Ventilação Intrapulmonar Percussiva - (VIP)

INTRAPULMONARY PERCUSSIVE VENTILATION (IPV®)
What is Intrapulmonary Percussive Ventilation (IPV®)?

The term Intrapulmonary Percussive Ventilation (IPV®) was coined by Dr. Forrest M Bird in 1980, to describe a Clinical Protocol and the Administering Device, to mechanically ventilate the Lungs with successive Percussive Sub Tidal Volume Deliveries, without firing the Hering Breuer stretch receptors, provoking an expiratory "cough like response”.

Essentially, IPV® in oversimplified terms, assists the respiration of patients with diseases which limit their normal respiration by helping to clear retained secretions from the lungs and then providing deep breathing to increase oxygen delivery to the alveoli as well as flushing carbon dioxide from the pulmonary airways.

To receive this type of mechanical ventilation, the patient breathes through an IPV® accessory device called a Phasitron®, which delivers rapid, high flow, mini-bursts (percussions) of Air or Oxygen into the lungs while simultaneously delivering therapeutic aerosols. IPV® loosens and helps propel deep retained airway secretions upward from the lungs where they can be more easily expectorated (coughed up).

IPV® has been proven to be an outstanding combining therapeutic procedure, in patients with obstructive pulmonary diseases; including, Bronchiolitis, Cystic Fibrosis, Asthma, Chronic Bronchitis, Bronchiectasis, Neuro-muscular disorders, Emphysema, (General COPD), as well as for Post Operative and Emergency Room (ER) airway management. IPV® can be self administered by home care patients through a mouthpiece or mask. In the hospital IPV® can be administered by, mouthpiece, mask or endotracheal tubes, as well as in combination with an intensive care ventilator.

IPV® is a universal Ventilatory program, combining the maximum Clinical Efficacies of all existing routine mechanical ventilatory procedures, directed toward:

1. Mobilizing pulmonary airways, congested by secretion retention, mucosal and sub mucosal edema and bronchiolar spasm.

2. Creating a bilateral uniform alveolar ventilation for enhancing oxygen uptake and carbon dioxide elimination.

3. Mechanically mixing Intrapulmonary Gases through "diffuse intrapulmonary percussion” to enhance endobronchial diffusion of Oxygen and the mobilization of peripheral CO2.

4. Providing a major periodic "Convective Tidal Flow” to wash out CO2.

5. Potentially providing a Mechanical "Vesicular Peristalsis” to augment "Physiological Vesicular Peristalsis” within the Pulmonary and Bronchial Circulation’s, as well as to provide for an augmenting "Intrathoracic Lymph Pump”.

Essentially, IPV® COMBINES the best features of ALL existing Pulmonary Care devices including:

1. High Density Aerosol Therapy.
2. Extrathoracic Percussion (Chest Physiotherapy).
3. Intermittent Positive Pressure Breathing.
4. Mechanical Chest Thumpers, Squeezers and Vibrators.
5. Upper Airway Secretion mobilizers.
6. Bi level (I-E PAP) breathing devices.
7. CPAP devices.
8. Postural Drainage.

The institutional use of IPV®, beyond secretion clearance and the resolution of diffuse or localized atelectasis, has been greatly expanded, secondary to the recent incrimination of High Intrapulmonary Tidal Volume deliveries under High Inspiratory Flowrates, creating Preferential Airway Delivery leading to barotrauma within the dependant lung structures.

CLASSICAL WAVE FORMAT DEPICTING IPV® LOGIC

A special manifold assembly, can interconnect the IPV® Phasitron® and Aerosol Generator assembly into conventional breathing circuits, employed on the majority of volume oriented ventilators. This enables the intrabronchial "Percussive Mechanical Mixing” of Respiratory Gases being delivered convectively, during scheduled tidal exchange.

Therefore, IPV® when employed during controlled volume oriented convective ventilation, provides for percussive intrapulmonary gas mixing and associated diffusion, thus allowing a decrease in the scheduled Tidal Volume pressure amplitude (PIP), without the atelectatic consequences of Low Tidal Volume Programming

Additionally, aerosolized medications and wetting agents can be delivered during the continuous IPV® percussion, of the pulmonary structures.

IPV® programming, allows the patient to breathe spontaneously through the "percussive ventilatory programming”, providing for an assisted step inflation of the lungs, followed by a percussive step down deflation to the programmed expiratory baseline; during passive exhalation.

GENERAL CLINICAL DESCRIPTION OF INTRAPULMONARY PERCUSSIVE VENTILATION (IPV®)

What are some of the cardinal Clinical considerations of (IPV®)?

Intrapulmonary Percussive Ventilation (IPV®) is a form of cardio-respiratory therapy, administered to the Pulmonary Airways by a pneumatic (air) powered device called a Percussionator®.

The patient breathes through a mouthpiece which delivers high flow mini-bursts of air into the lungs at rates of over one hundred fifty (150) times each minute.

During the percussive bursts of air into the lungs, a continued pressure wedge is maintained, while a high velocity percussive inflow opens airways and enhances intra-bronchial secretion mobilization.

A traditional medication for Aerosol Therapy, called racemic epinephrine in a 2.25% aqueous concentration, one half cc (6 drops), is diluted with 20 cc of water and aerosolized into the lungs by a special therapeutic mist generator.

NOTE: Beta (bronchial dilators) are widely used with IPV®, they should be diluted with normal (.85%) Saline. Do not employ Pharmaceutical Agents for intrapulmonary topical delivery without Clinical Data to support their dilution and use during IPV® therapy.

The aerosol mist is delivered topically throughout the lungs, during therapeutic percussion, by the IPV® Intrapulmonary Percussionator®.

The misting of topical dilute Alpha/Beta aerosols within the lungs, reduces the adhesive and cohesive forces of retained airway secretions, decreases swelling within the walls of the pulmonary airways and relaxes potential spasm of the terminal bronchioles (small terminal airways) of the lungs.

Each percussive interval is programmed by the Clinician and/or Patient. Normally, the ON/OFF Percussion Button is depressed, creating a continuous Percussion allowing the Patient to Breath through the Percussion as desired. While the Percussion Button is held depressed, the lungs are percussed, mixing oxygen, carbon dioxide and nitrogen with a medicated mist. At the end of the Percussive Interval, the Percussive Button is released allowing the exhalation of the well mixed intrapulmonary gases from the lungs. The Button is only released to Expectorate or rest.

After each deep exhalation, the percussive interval is started anew, refilling the lungs with fresh, moist, medicated respiratory gases. The cyclical intrapulmonary exchange of well mixed respiratory gases serves to flush out carbon dioxide and renew oxygen.

Whenever there is a desire to cough or expectorate, the Percussion Button is released until the coughing episode is completed or the secretions are raised and cleared. A routine IPV® therapy session lasts approximately twenty minutes.

Who can potentially benefit from IPV® Therapy?

IPV® therapy is a combination of Therapeutic Aerosol, Volume Oriented IPPB, CPAP and Chest Physiotherapy, directed toward the mobilization and raising of retained endobronchial secretions and the resolution of diffuse patchy atelectasis. Therefore, Patients who typically would be expected to respond to these therapeutic regimes, would encompass: Institutionalized Patients with compromised cardiopulmonary functions secondary to accidental trauma, burns, surgical protocols, myopathic limitations and acute insults to chronic obstructive pulmonary diseases.

Such potentials would include, Acute patients requiring Emergency Room stabilization because of cardiopulmonary shock, acute obstructive pulmonary disease, neuromuscular disorders, smoke inhalation, aspiration of intrapulmonary irritants, left congestive heart failure complicated with acute pulmonary edema. Chronic Patients with obstructive pulmonary disease, presenting with mild to moderate or severe clinical symptoms. Patients with combination Fibrotic Obstructive Disease with Cor Pulmonale etc.

TAKING A TREATMENT WITH IPV®

What is involved in taking IPV® Treatments?

Every IPV® device is shipped with Instruction Manuals and general instructions. Home care IPV® Percussionators® are shipped with a VHF Video Tape. A qualified IPV® Technician must teach each patient how to use IPV®, with both a Mouthpiece as well as a Mask. Without proper Instruction a patient may only receive a small component of the potential Clinical Efficacy of IPV®.

After the IPV® Device is turned ON, there is a continuous flow of aerosol (Nebulization). To create Intrapulmonary Percussion, the Trigger (Button) must be held compressed by a thumb or finger. After the first few IPV® Therapy Sessions, the patient will learn to relax and let the Percussionator® do the work of Breathing. Taking a Breath during Lung Percussion, will override the Intrapulmonary Percussion. Normally, a continuous Percussion is maintained, with the patient taking a normal breath whenever they feel the urge, with pauses to expectorate or have brief conversations etc.

Basic IPV Check List:

1. Select 30 psig Regulated Pressure and EASY (full counterclockwise) on IPV® Percussionator® control knob.
2. Set up Breathing Head and Install solution in Nebulizer.
3. Rotate ON/OFF Switch to ON and check aerosol mist flow from the Phasitron®.
4. Hold the Mask tightly over the face and/or use the mouthpiece, forming a tight seal with the lips. Avoid Nose Clips. Breathe the issuing aerosol.
5. Depress the Percussion Button for Percussion, allowing the Percussive Breaths to freely enter the lungs, only taking breaths when desired.

NOTE: Initial nasal venting is a common occurrence and can be corrected by employing the soda straw analogy, "sucking in and then blowing out through the mouthpiece”, until nasal venting is eliminated. When Breathing through active Percussion "the physiological inspiratory demand”, is percussively assisted by the step inflation of the lungs. During Exhalation, the Percussion produces a passive step deflation of the lungs. Learn to let the Percussion do the work of breathing and only take a breathe through the continuous percussion when desired.

6. When expectorating, release the Percussion Button, remove the mouthpiece and cough up raised secretions.
7. It is important "to raise” the mobilized endobronchial secretions. This is accomplished by increasing the force of percussion within the lungs. This is scheduled by gradually increasing the Percussive Amplitude, by rotating the PERCUSSION control knob Arrow (clockwise) until the index arrow is under or past the 12:00 position. This is started, after the first five minutes of Percussive Therapy, gradually rotate the Arrow on the control knob (clockwise) to the 12:00 position for several minutes. Continue to periodically move the PERCUSSION control knob back and forth between EASY and the 12:00 o’clock position, during the balance of the IPV® treatment.
8. It is important to keep the mouthpiece in the mouth between percussive pauses throughout the treatment, to receive the full benefit of aerosol, the Percussive Treatment usually takes about fifteen to twenty minutes.
9. If a more forceful Intrapulmonary Percussion is desired, increase the OPERATING PRESSURE upward toward 40 psig.

ABOUT INTRAPULMONARY PERCUSSIVE VENTILATION (IPV®)

What is the Logic for Control over the Percussive Delivery Pressures entering the Lungs?

A special calibration procedure provides the Percussionator’s with specific ratios between the Percussive Flow/No Flow intervals, determining the Pressure Wedge during repetitive Percussive Bursts. The amplitude (impaction) of the Percussive Bursts are controlled by the Operational Source Pressures. Nominal Regulated Source Pressures are between 30 and 40 psig. During recent years, the monitoring of Percussive Airway Pressures with a Manometer has been found to provide minimal Clinical Guidance.

More important is the monitoring of the Thorax during early teaching and follow on instructional periods, to make certain that the entire Thorax is being percussed (from the top to base parameters on both sides). If the Percussionator® is set up for Proximal Airway Monitoring, a Red Service Socket just behind the Mouthpiece is interconnected to the Gauge Socket on the Percussionator® Housing, by a Red Interfacing Tubing. Wedge pressure regulation is automatic, being determined by the Operational Source Pressure and the selected Percussive Impaction Frequency against pulmonary resistances. Nominally, Wedge pressures are maintained between 10 and 15 cm H2O.

What are the general provisions for Clinically Programming the family of IPV Percussionators?

· Normal Source Operational Pressures for the IPV® Percussionators are provided Institutionally by a 50-60 psi Air or Oxygen plumbing system. The Impulsator® Percussionator® has a self contained Medical Air Compressor and Regulation System. When standard 50-60 psig Air/Oxygen Source pressures are used, the Operational Pressures entering the Percussionators are precisely regulated by a line Pressure Regulator and Gauge, which is either internally or externally positioned depending upon the Percussionator® packaging. An OPERATIONAL PRESSURE control knob, allows the selection of the desired Operational Pressure, nominally, 30 psig for patient initiation, with optimal Therapeutic Pressures of 40 psig.

· The PRECISE mean Percussive Wedge Pressure, is established by the factory or authorized technician though the calibration of the Timing Circuit Outflow Orifice. The Percussive Frequency is then controlled by the Clinician or Patient by the rotation of a single control knob labeled PERCUSSION. The Impaction and associated Wedge Pressures are then controlled by rotation of the control knob.

· A (counterclockwise) control knob Arrow rotation toward EASY increases the Percussive Impaction Frequency by decreasing the Impaction Time, this position is nominally employed for initiating Patients. As the PERCUSSION control knob Arrow is rotated clockwise past the 12:00 position toward HARD, the Percussive Impaction is increased (with a decreasing Impaction Frequency) because of a lengthening Impaction Time. The 12:00 PERCUSSION control knob Arrow position, generally provides for the optimal therapeutic schedule.

NOTE: THE SOURCE GAS MUST PROVIDE FOR AN INSTANTANEOUS UNRESTRICTED DEMAND INFLOW of 1.4 cu. ft. per minute (40 liter) to the Percussionator® at 50 psi.

WARNING: DO NOT USE COMMERCIAL AIR COMPRESSORS WITHOUT TOTAL WATER SEPARATION FACILITIES.

UNDERSTANDING THE COMPONENTS OF THE BREATHING HEAD ASSEMBLY

How does the Percussionaire® Aerosol Generator (Nebulizer) Manufacture a Dense Therapeutic Mist?

The novel pneumatic Aerosol Generator manufactures a specific Therapeutic spectrum of Particles forming a dense mist for Intrapulmonary Transport. Air or Oxygen under a pressure of about 20 psi is delivered into a (yellow) Service Socket on the bottom of the Aerosol Generator Bowl.

Air under pressure flows from the (hollow orificed), Jet Post, through an orificed Sleeve, creating a suction between the Post and the Sleeve. The Therapeutic Solution within the Nebulizer Bowl is drawn into a space between the hollow orificed Post and the Sleeve, through holes in the bottom of the Sleeve. Liquid Solution is blown out the hole (orifice) in the top of the Sleeve to impact against a Diffractor (ball). The Diffractor breaks up the stream of Liquid into a countless number of micro-particles, forming a dense Therapeutic Mist.

How does the Aerosol Generator deliver the micro-particles into the Lungs?

The Aerosol Generator manufactures a constant dense mist of Micro-particles from its approximate 20 cc of initial Liquid Solution. The mist is delivered into the Entrainment Port of the Phasitron® Injector/Exhalation Valve which is coupled to the Outlet Tee of the Aerosol Generator. The mist flows through the inside of the Phasitron® Venturi, through the Patients Mouthpiece then into the Lungs. The mist, being continuous, allows the Patient to Breathe Therapeutic Aerosol alone or during Intrapulmonary Percussion.

THE DYNAMIC IPV® THERAPEUTIC BREATHING CIRCUIT, IN CROSS SECTION

Briefly explain how the IPV® Breathing Circuits Work?

The Breathing Head in Cross Section demonstrates the role of the KEY Phasitron® in providing for the NOVEL concept of Intrapulmonary Percussive Ventilation (IPV®). Essentially, the Phasitron® synchronizes the pulsed flow of Respiratory Gases from the Percussionator®, into Percussive Air/Oxygen Injections into the Pulmonary Airways. Without the Phasitron®, with its clean near instantaneous opening and closing, the PERCUSSIVE DELIVERY of Intrapulmonary Gases would not be possible, because of increasing inadvertent Positive End Expiratory Pressures (PEEP), as cycling rates are increased.

The Venturi (without back pressure) within the Phasitron® entrains (draws in) about 5 molecules of room air, mixed with mist from inside the Aerosol Generator through the Entrainment Port of the Phasitron®, for every molecule Injected from the Venturi Jet (Orifice).

Therefore, the Phasitron Venturi initially increases the volume (size) of the near sonic Air Bursts entering the Lungs, by adding entrained molecules to each molecule delivered from the Venturi Jet. The Venturi forms a unique air clutch which protects the Lungs against a sharp (dissecting) pressure rise. The Entrainment within the Venturi responds to Intrapulmonary back pressures, as back pressures rise, the number of entrained molecules (for intrapulmonary delivery) are automatically decreased (regulated).

The Venturi is moved back and forth within the Phasitron Body by an orificed Diaphragm. The Venturi Assembly is moved forward during Percussive Impaction, to inject a Burst of Respiratory Gases through the Mouthpiece etc. into the Lungs. Between Bursts (stroke deliveries), the Venturi Assembly moves backwards uncovering the Exhalation Port. This allows some of the previous Injected Respiratory Gases to flow out of the Lungs to Ambient (into the room), between successive Bursts.

The Percussionator maintains a precise Automatic ratio between Phasitron® opening and closing times, the base calibration RATIO is 1:2.5 which will vary slightly with selected Impaction Frequency. It is this automatic control over the opening and closing ratios, which determines the precise Therapeutic Intrapulmonary wedge pressure. The flow of mist from the Aerosol Generator is continuous, mixing with both inspiratiory and expiratory gas flows. Exhaled condensate (moisture) is collected within a corrugated tubing "Condenser”, after leaving the Exhalation Port, to prevent ambient contamination as well as the sprinkling of clothing.

Essentially, the Phasitron® opens and closes about 100 to 300 times each minute during the Percussive Interval, to provide for a pressurized Percussive physical/physiological gas inflow, then opens during the passive physiological outflow from the lungs.

WARNING: Without proper internal calibration, the Percussive I/E (i/e) Ratios will not provide the correct mean "Intrapulmonary Wedge Pressures” for Optimal Percussion. This condition can reduce the therapeutic efficacies, as well as make Therapy most uncomfortable.

INTRAPULMONARY PERCUSSIVE VENTILATION (IPV®) FOR THE HOME CARE PATIENT

What is the suggested Percussionaire® IPV® Percussionator® for Home Care?

THE IPV® HOME CARE IMPULSATOR® THERAPY SYSTEM

IPV® IMPULSATORS now serve in thousands of homes, on medical prescription, to assist Patients with chronic Cardiopulmonary Diseases, in order to maintain an improved quality of life, while typically decreasing the number of annual hospitalizations, secondary to acute infections.

Home Care Patient populations consist of Cystic Fibrosis, status Asthma, Chronic Bronchitis, Bronchiectasis, Myopathic Disorders Pulmonary Emphysema, (COPD), and other cardiopulmonary combinations.

Like any Clinical Therapeutic Protocol, the patient must be taught to correctly perform IPV® and schedule daily sessions for maximum clinical efficacy. The normal revelation of Patients who are not engaged in an effective IPV® HOME CARE PROGRAM, is when their hospitalizations before IPV® was commenced, are essentially the same after Domiciliary IPV® treatments have been supposedly continued on a daily schedule, for over a year.

The IMPULSATOR® is a total IPV® Therapy Station, with a special heavy duty medical Air Compressor capable of delivering the required 1.4 cu ft. per minute of demand Airflow at pressures of 50 psi. Two ac voltage and cycle (hz) combinations are available, 115/60 and 220/50. Special mated power cords are required. The 115/60 device is U/L listed in the US, along with ISO 9000-2 and CE in Europe.

Engineered cooling and the internal warming of the IPV timing and flow circuits prevent the condensation of water within the functional pneumatic circuits of the Impulsator®. The condensation of water within pneumatic devices has long served to deteriorate functions and limit long term durability of medical Respirators.

The IMPULSATOR® is well constructed, employing "state of the art" technology to allow Portability, when properly protected and not dropped. A Handle for transport, is built into the top overall design of the system. The Impulsator® should be set up in a clean dust free environment away from sources of high humidity. The unit weighs approximately 20 pounds and should be set up on a Table that is level and secure to prevent it's dynamic migration.

An Electrical Rocker Switch is employed to turn the IMPULSATOR® - ON and OFF).

The IMPULSATOR® employs a dynamic Pressure Regulator with selectable Operational Pressures of from 25 to over 40 psig.

Four color coded Service Sockets provide for the interfacing of an IPV® Interfacing Harness with the IPV® Breathing Head and/or (Semi Disposable) single patient use Breathing Head Assembly.

On special order, a Manometer can be attached to the IMPULSATOR® for research purposes etc.

The dust filter on the intake port must be serviced in accordance with the operational environment.

Domiciliary patients using IPV® should have their IMPULSATORS® serviced annually or at any time clinical efficacy is not as expected.

BIBLIOGRAPHY FOR INTRAPULMONARY PERCUSSIVE VENTILATION (IPV®)

1. Deakins, K., RRT, Smith, P, DO, Cancellaire, S., RRT, Chatburn, R.L, RRT: "Comparison of Conventional CPT with Intrapulmonary Percussive Ventilation for Treatment of Atelectasis in the Intubated Patient” Abstract Respiratory Care, Vol. 44, No. 10, P 1248, 1999

2. Deakins, K, RRT, Chatburn, RL, RRT: "Pilot Study of Intrapulmonary Percussive Ventilation for Treatment of Atelectasis in the Intubated Pediatric Patient” Abstract Respiratory Care, Vol. 44, No. 10, P 1248, 1999

3. Castile, R.,Tice, J., Fluke, R., Filbrun, D., Varekojis, S., Mccoy, K., "Comparison of Three Sputum Clearance Methods in In-Patients with Cystic Fibrosis" Pediatric Pulmonology, 1998;

4. Varnell , Margaret, RN, RRT, Nichols, K. , RRT. "IPV Use Expands to More Patients". Advance for Respiratory Care Practitioners, July 13, 1998, 26-27.

5. Stegmaier, James, RRT, RPFT: Lewarski, Joseph, RRT. "IPV Beneficial for Treating Refractory Hypoxemia." Advance for Respiratory Care Practitioners, March 31, 1997, pg 6, 54.

6. Miller, Charles R.,MS,RRT; "Comparing Flutter Device to IPV." Advance for Respiratory Care Practitioners October 13, 1997 pg.11 & 1

7. Lentz, Christopher W., MD; H.D. Peterson, DDS, MD. "Smoke inhalation is a multilevel insult to the pulmonary system." Critical Care, 1996, 2:230- 235.

8. Ennis, John, RRT, CCT. "Rural Hospital Offers High-Tech Care." Advance for Managers of Respiratory Care., 17 June, 1996, p. 20

9. Birnkrant, David J., MD, FCCP; John F. Pope, MD; Joe Lewarski, RRT, RCP: Jim Stegmaler, RRT, RCP. "Persistent Pulmonary Consolidation, Treated With Intrapulmonary Percussive Ventilation." Pediatric Pulmonology, 1996, 21, pp. 246-249. 10.

10.Varnell, Margaret, RRT; "IPV Finds New Applications for Use". Advance for Manager of Respiratory Care, July 15, 1996, p 15 con't p 38.

11. Miller, Charles R., MS, RRT; Pam Gibbs, AS, RRT. "Intrapulmonary Percussive Ventilation." Advance for Manager of Respiratory Care, March 20, 1995.

12. Homnick DN, MD., MPH., FCCP; C. Spillers, F. White. "The Intrapulmonary Percussive Ventilator Compared to Standard Aerosol Therapy and Chest Physiotherapy In The Treatment of Patients With Cystic Fibrosis." Pediatric Pulmonology, 1995; 20, pp 50-55.

13. Natale JE, MD, PhD; Pfeifle J., RRT; Douglas N. Homnick, MD., MPH., FCCP. "Comparison of Intrapulmonary Percussive Ventilation and Chest Physiotherapy: A Pilot Study in Patients with Cystic Fibrosis." Chest , 1994: 105:1789-1793.

14. Miller, Charles R., MS, RRT; Pam Gibbs, RRT. "IPV Offers Cost-Effective Method For Self-Administered Therapy." Advance for Manager of Respiratory Care, Jan/Feb, 1993, Vol. 2/Number 1, pp 32-33.

15. Soudon, PH; "Mechanical Ventilation by Tracheostomy in Neuromuscular Disease: Experience and Evaluation." European Respiratory Review, 1993, 3:12, pp 300-304.

To this date, there has never been a major HOME CARE STUDY on any Therapeutic Respirator/Ventilator. Most reviews are Anecdotal. Home Care studies are very difficult if not impossible to assemble in a scientific meaningful format. Several years ago, a new format came out of England called the Saint George profile. A very major ongoing study of "Home Care Patients” using IPV® in Europe, is now underway, with hundreds of HOME CARE IPV® patients entered into a modified "Saint George Format”.

Volumetric Diffusive Ventilation (VDR®) is the Institutional Critical Care Version of IPV®. Therefore, published "Objective Scientific Documentation” derived from these patient populations, with similar cardiopulmonary embarrassments, objectively project into the Clinical aspects of IPV® therapy.

BIBLIOGRAPHY FOR VOLUMETRIC DIFFUSIVE RESPIRATION (VDR®)

1. SMOKE INHALATION IS A MULTILEVEL INSULT TO THE PULMONARY SYSTEM; Lentz, Christoper W., MD; H.D. Peterson, DDS, MD.; Critical Care, 1996, 2:230- 235.

2. VENTILATOR STRATEGIES FOR SMOKE INHALATION: Mlcak, R.P., The Journal for Respiratory Care Practitioners, February/March 1996; 103-106.

3. COMBINED PRESSURE CONTROL/HIGH-FREQUENCY VENTILATION IN ADULT RESPIRATORY DISTRESS SYNDROME AND SICKLE CELL ANEMIA: Baird, J.S., Johnson, J.L., Escudero, J., Powers, D.R.: Chest 1994; 106(6): 1913-1916.

4. THE FIFTH QUINTENNIUM: 1989 to 1993; Warden, Glenn: Burn Care Rehabilitation 1993.

5. DECREASED PULMONARY DAMAGE IN PRIMATES WITH INHALATION INJURY TREATED WITH HIGH-FREQUENCY VENTILATION; Cioffi, William G. and others; Surgery 1993; 218:3. 328-337.

6. DECREASED PULMONARY BAROTRAUMA WITH THE USE OF VOLUMETRIC DIFFUSIVE RESPIRATION IN PEDIATRIC PATIENTS WITH BURNS; Rodeberg, DA and others; Burn Care Rehabilitation 1992; 13:506-511. Abstract published in Year Book of Surgery 1993; pages 80-81.

7. PROPHYLACTIC USE OF HIGH-FREQUENCY PERCUSSIVE VENTILATION IN PATIENTS WITH INHALATION INJURY; Cioffi, William G. and others; Surgery 1991; 213:6 575-582.

8. HIGH FREQUENCY PERCUSSIVE VENTILATION; Davis, K. and others; Problems in Respiratory Care 1989; 2:1. 39-47.

9. HIGH-FREQUENCY PERCUSSIVE VENTILATION IN PATIENTS WITH INHALATION INJURY; Cioffi, William G. and others; Trauma 1989; 29:3. 350-354.

10. THE ROLE OF HIGH-FREQUENCY VENTILATION IN POST-TRAUMATIC RESPIRATORY INSUFFICIENCY; Hurst, J.M. and others: Trauma 1987; 27:3. 236-241.

11. HIGH-FREQUENCY PERCUSSIVE VENTILATION COMPARED WITH CONVENTIONAL MECHANICAL VENTILATION; Gallagher, T. James and others; Presented at Society of Critical Care Medicine, May, 1985; updated in Intensive Care and Emergency Medicine, 1987.

12. LUNG COMPLIANCE, AIRWAY RESISTANCE, AND WORK OF BREATHING IN CHILDREN AFTER INHALATION INJURY; Mlcak, R. and others: Journal of Burn Care and Rehabilitation NOV/DEC 1997; 531-534.

13. THE USEFULNESS OF COMBINED HIGH-FREQUENCY PERCUSSIVE VENTILATION DURING ACUTE RESPIRATORY FAILURE AFTER SMOKE INHALATION; P. Reper, R. Dankaert, F. VanHille, Y. VanLaeke, L. Duinslaeger, A. Vanderkelen; Burns, 1998; 24:34-38.

14. FIFTY YEARS OF POSITIVE PRESSURE BREATHING; Bird Institute of Biomedical Technology, F. M. Bird 2000

15. THE PHARMACOLOGICAL CONSIDERATIONS AND ASSOCIATED CLINICAL REVELATIONS OF INTRAPULMONARY VENTILATION (IPV®), Bird Institute of Biomedical Technology, F.M. Bird 1998

16. INTRAPULMONARY PERCUSSIVE VENTILATION (IPV®) and associated MECHANICAL INTRATHORACIC VESICULAR PERISTALSIS; Bird Institute of Biomedical Technology, F.M. Bird 1999

17. UNDERSTANDING WEDGE PRESSURE, PERIPHERAL AIRWAY STABILIZATION AND ESOPHOGEAL OPENING PRESSURES DURING INTRAPULMONARY PERCUSSIVE VENTILATION (IPV®); Bird Institute of Biomedical Technology, F.M. Bird 2000

INSTITUTIONAL IPV® DEVICES

Define the IPV® Percussionators® that are available for hospital use?

A number of the standard IPV® family of devices, for various levels of convenience, are addressed through unique packaging. Each Therapeutic IPV® Device, employs the same Phasitron® Breathing Head and Injectron® type aerosol generator.

All Therapeutic IPV® devices can employ a Mouthpiece (physiological airway, controlled by the patients lip pressure), to prevent leakage to ambient and/or a face mask for patients unable to use a mouthpiece.

Institutionalized patients with endotracheal tubes, can be ventilated by connecting the Phasitron® directly to the 15 mm male end of the ET. "Percussive Inspiratory Flowrates” are regulated by operational pressures”, which can be adjusted for Un-cuffed or Semi Cuffed endotracheal tubes, to cover "cephalad leakage” and comply with the existing gross pulmonary compliance.

WARNING: DO NOT ADULTERATE PERCUSSIONAIRE® BREATHING CIRCUITS, BY SUBSTITUTION OF COMPONENTS.

Beyond the standard IPV Therapy Breathing Circuit is a Single Patient use IPV® Breathing Head Assembly. The Single Patient Use "Semi Disposable” Therapeutic Breathing Head Assembly, consists of a Lexan® Housing, forming an integral Phasitron/Injectron® unit with only a removable Nebulizer Bowl.

The components of the IPV® Therapy Phasitron/Injectron use the same internal components as the Autoclavable multi use IPV® Phasitron injector/exhalation valve and the Injectron® intensive care Aerosol Generator. Therefore: The Therapeutic Efficacy of the DUO™ PHASITRON® is the same as the reusable (multi-patient) Autoclavable IPV® Phasitron Breathing Head Assembly.

The Single Patient integrated Design, allows minimal re-assembly. The Phasitron and Nebulizer are integral, therefore, only the Nebulizer Bowl is removable. The unit can be mechanically washed and/or cold sterilized between treatments. Lexan® is a fine strong (polycarbonate) plastic, however; it can not be autoclaved under high temperatures. The unit can be reverse flushed during cleansing by removing the Nebulizer Bowl. The IPV start/stop Trigger enables left or right Handed Patients operational ease. The Injectron® Nebulizer is a powerful IPV® Nebulizer with boosted spectrum and output.

NOTE: Both the Phasitron and Injectron Jet Chambers can be "purged of sterilizing solutions by flipping”. Internal Cavities can be positionally self drained. The Phasitron® "Duo Assembly™” uses the standard IPV Interfacing Harness.

THE SINGLE PATIENT USE PHASITRON® DUO™ BREATHING HEAD

INSTITUTIONAL IPV® DEVICES ARE COMPREHENSIVE

THE IPV-1 PERCUSSIONATOR ® FOR INSTITUTIONAL USE Part # F00001

The Institutional "Work Horse” is the IPV-1 which is a Universal IPV® Percussionator® employing Institutional Oxygen and Air sources to provide for the selectable, regulated, operational Percussive Sub Tidal delivery ranges.

The family of IPV-1® Percussionators continue to be employed to provide for the Percussive High Frequency Modulation of Convective Tidal Volumes and CPAP/PEEP. This has been satisfied by providing standard Volume Oriented Ventilators, with a programmable intrapulmonary Mechanical Mixing of the endobronchial gases, to effectively enhance blood gas interfaces.

Intrapulmonary Percussive Ventilation (IPV®) in association with convective "Volume Oriented Mechanical Ventilation”, has long served to decrease existing Peak Inspiratory Delivery Pressures (PIP), thus; decreasing pulmonary barotrauma secondary to Preferential Airway delivery, into hyperinflated Dependent Lung Structures.

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THE PERCUSSIONAIRE® *GOLD EDITION IPV-1S® UNIVERSAL PERCUSSIONATOR

The Millennium year 2000 is the twentieth anniversary of Intrapulmonary Percussive Ventilation (IPV®), as conceived by Dr. Forrest M Bird. Over the years, both the Institutional and Domiciliary uses for IPV® has continued to expand. Out of this IPV® expansion, there were requests for a Special Ruggedized Low Profile Universal IPV® Percussionator packaging, which would universally adapt to existing Volume Oriented Critical Care Devices. The IPV-1S is a member of the IPV® family with the same functions as the IPV-1.

The low profile IPV-1S® *Gold Edition, is packaged in an all metal housing with a Universal Mounting Bracket, which will interface with existing Volume Ventilators world wide. The IPV-1S® serves to resolve Pulmonary Atelectasis and mobilize Endobronchial secretions, as well as enhance intrapulmonary gas exchange.

Because of the current warnings in the Medical Literature, to reduce conventional Tidal Volume Delivery, to limit barotramatic potential, Pulmonary Atelectasis can be expected to increase, further justifying the use of adjunctive IPV®.

· The Gold Edition housings may have custom color finishes etc.

THE UNIVERSAL TXP® PERCUSSIONATOR® VENTILATOR

The Universal TXP® Ventilator is a completely self contained Ventilatory System, for Institution or Home use, utilizing standard world wide ac power to operate the self contained high volume compressor. This TXP® Percussionator®/Ventilator has a selectable standard CMV "Time Cycled Ventilator”, as well as, an Internal Percussionator® for standard IPV® Therapy.

The TXP® Universal VENTILATOR Percussionator® will ventilate the smallest to the largest lungs, in all patient populations. This unit is ideal for the small hospital and/or the remote medical Emergency Room, without installed wall oxygen and air sources. Additionally, this Ventilator can serve as an ideal IPV® Therapy System, for Home Care Respirator Dependent patients. The TXP® Universal Ventilator, with a complete "Time Cycled Standard Respirator” can be powered alternatively by Oxygen, Air and/or standard Electricity should the primary home care respirator/ventilator fail.

The IPV® Spanker® and mini-Spanker Percussionators, have the same Percussive programming potential as the entire family of IPV® Percussionators. The Spankers are packaged in miniaturized housings. They are Ideal for mobile Institutional use, or for use in restricted accommodations. Additionally, they present low cost acquisition with the same integrity as the entire family of IPV® devices. The Spanker has a standard Manometer in the reverse end of the cylinder, as opposed to the mini-Spanker which does not have a Manometer. Each Spanker comes complete with all necessary operational accessories.

The mini-Spanker MPS # F00019 with included Spanker accessories

IPV® BREATHING CIRCUIT SET UP INSTRUCTIONS

What should I know about setting up the IPV® Breathing Circuits?

The setup for both the multi use and semi disposable IPV® Breathing Circuits for attachment to the family of IPV® Percussionators®, are very much the same.

1. Assemble the multi use Phasitron®.

2. Note: The Single Patient use IPV® Breathing Head is permanently assembled, with only the Nebulizer Bowl being Removable.

3. Install the prescribed medication in the Nebulizer Bowl. Dilute with 20 cc of water if aqueous and/or physiological (.85%) saline, then twist lock the Nebulizer Bowl to the Nebulizer Housing by positioning and rotational locking.

4. Force lock, the green inlet port of the multi use Phasitron® into the IPV® Nebulizer outlet port, in the desired position.

5. Attach the mouth piece to the multi use Phasitron® and/or the Mask, to either the multi use or "semi disposable” Patient Breathing outlet of the Phasitron®.

6. Attach the Interfacing Harness as follows:

7. The Red tubing interconnects to the Red GAUGE port of the Percussionator® and the Red Monitoring Port of the Phasitron®.

8. The Yellow tubing interconnects to the Yellow AEROSOL Port of the Percussionator and the Yellow Nebulizer Elbow on the bottom of the Nebulizer Bowl.

9. The White tubing interconnects to the White PHAS port of the Percussionator and the White Phasitron Jet Port on the white Phasitron Cap.

10. The Green tubing interconnects to the Green REMOTE Port of the Percussionator and the Green Interrupter Port on the Nebulizer Housing.

11. Attach the large bore condenser tubing to the IPV® Phasitron Outlet, of either the multi use or semi disposable Breathing Head Assemblies.

Note: IPV® Manuals and Educational Tapes provide more detailed assembly procedures.

THE ADMINISTRATION OF INTRAPULMONARY PERCUSSIVE VENTILATION (IPV®)

Explain the General Administration of IPV®?

Many Patients are first introduced to IPV within the Hospital Facilities after accidents, surgical, recuperation or acute infections.

Other Patients are directed to Outpatient Facilities by their prescribing Physicians. Outpatient Facilities provide for large Patient populations requiring Recovery Programs, as well as those who have experienced acute infections aggravating underlying COPD.

Patients with chronic forms of COPD are best served with a Home Care program sponsored by their Physician, Medical Facility or Ethical Care Organization. Ideally, the Home Care Program will address total Physician coverage, Technician training and re-training by a competent Respiratory or Physical Therapist, a visiting Nurse to cover Hygienic and Environmental considerations and last but not least a well qualified Dietitian.

BRIEF SET-UP PROCEDURES FOR IPV® THERAPUTIC PERCUSSIONATORS

1. Interconnect and organize the IPV Breathing Circuit.

2. Service the Aerosol Generator (Nebulizer) with .5 cc (6 drops) of a 2.25% Racemic Epinephrine, diluted with 20 cc of clean water and/or Medical Prescription.

3. Rotate the PERCUSSION control knob Arrow with the Index under the 12:00 top position.

4. Confirm and activate the 35-60 psig source of Medical Air or Oxygen.

5. Select an Operating Pressure of 35 psig on the Percussionaire® Line Pressure Regulator.

6. Check out IPV functions.
a) Observe mouthpiece or mask for a dense aerosol mist.
b) Hold Percussion Button Down and observe a cyclic Percussive function.
c) Rotate the Percussion control knob Arrow full travel in both directions, and observe a change in Percussive Impaction rates. Release Percussion Button and rotate Percussion Control Knob Arrow to EASY the (full counterclockwise) position.

7. Start IPV Therapy by first Breathing mist for up to one minute.

8. With lips tight around Mouthpiece, Hold Percussive Button down and allow the Percussionator® to keep the Lungs semi inflated with continuous Percussion. When desired, inhale and exhale through the Phasitron®, only releasing the ON/OFF Button to Expectorate or pause during Therapy. The Therapy session usually lasts from fifteen to twenty minutes.

9. Adjust the PERCUSSION control knob (clockwise) toward the 12:00 Index for increased Percussion and/or increase Operational Pressures up toward 40 psig if desired, then schedule the desired Impaction Rate on the PERCUSSION control knob. Breathe Aerosol Mist through the Mouthpiece when not Percussing. When the Nebulizer is empty discontinue treatment.

Correct Patient orientation is an important component of IPV® Therapy. Position the Elbow on an Armchair Restpad, the Thumb or Finger on the Percussion Button and the Phasitron Mouthpiece or Mask correctly angled to the Lips.

Patient positioning is all important for maximum Clinical Efficacy, whether in the recumbent of sitting positions. Under no circumstances should the Patient be "bent over" the spine should be fairly straight (within pathophysiological limits) in a comfortable relaxed position whether in bed or in an ARM CHAIR. Do not use hard uncomfortable armless chairs.

THE SINGLE PATIENT (DUO™) BREATHING HEAD ASSEMBLY

The Single Patient integrated Design, allows minimal re-assembly, the Phasitron® and Nebulizer are integral, therefore, only the Nebulizer Bowl is removable. The unit can be mechanically washed and/or cold sterilized between treatments. Lexan is a fine strong (polycarbonate) plastic, however; it can not be autocalved under high temperatures.

The IPV start/stop Trigger enables left or right Handed Patients operational ease. The Injectron® Nebulizer is a powerful IPV® Nebulizer with boosted spectrum and output. Both the Phasitron® and Injectron® Jet Chambers can be "purged of sterilizing solutions by flipping”. Internal Cavities can be positionally self drained. The Phasitron® Duo™ assembly uses the standard IPV® Interfacing Harness.

The (semi disposable) Single Patient use DUO™ PHASITRON® and Nebulizer Assembly, functions exactly like the multi use Phasitron®, eliminating assembly procedures. Clinical efficacy of both Breathing Heads are identical.

WHAT TWENTY YEARS EXPERIENCE WITH IPV® PATIENTS HAS REVEALED

What has been learned about IPV® since it was first introduced?

At this writing, certain (living) home COPD patients have used IPV® for over eighteen years. During this period of time, IPV® protocols employed in the home and institution, have not demonstrated any side effects or trauma which would not be expected by any other positive pressure (trach positive) mechanical respirator/ventilator. Because IPV® does not maintain a static apneustic "peak inspiratory pressure” against the pulmonary structures, which is possible with "volume oriented mechanical ventilators”, little if any barotrauma could be expected when IPV® advisory programs are followed and typical contraindications for all trach-positive ventilatory devices are honored.

Experiences from Home Care patients remaining on IPV® for many years, confirm the Safety and Effectiveness of IPV®. Backing up Domiciliary Care are many Institutional experiences with IPV® which continue to expand in scope and quantity. Current Guidelines for IPV® Therapy have been influenced by these experiences.

Intrapulmonary Percussive Ventilation (IPV®), if not properly introduced and administered to the Patient, can provoke considerable apprehension. To minimize initial stress, the Patient must be assured he or she has control over the device at all times. This is one of the reasons why all Clinicians teaching IPV® protocols must have totally mastered all IPV ® concepts on themselves.

The IPV® device should be prepared in accordance with recommended initial instructions. The Patient must be comfortably positioned in a sitting or recumbent posture. Additionally, the rational for IPV® Therapy should have been explained to the cooperative Patient before actual Therapy is started. Experience has demonstrated, it is not necessary to employ traditional "postural drainage" positions for IPV® Patients, during or after the Therapeutic session.

After activation of the Air or Oxygen Respiratory Gas source, the Patient should become familiar with the device by breathing Aerosol alone; without Percussion. Special attention must be directed toward sealing the lips around the flange of the Mouthpiece.

By learning how to "pucker" the lips around the mouthpiece, minimal "cheek flapping" will occur, when Percussive Therapy is started. Have the Patient learn the correct relaxed holding positions.

After the Patient has totally conformed to Dense Aerosol Therapy, and is comfortably managing the holding positions, a low amplitude Percussive Therapy can commence.

Establish an Operational Pressure of 30 psig and rotate the PERCUSSION control knob Arrow to EASY (the fastest cycling rate). First ask the Patient (with the Breathing Head held away from the lips) to repeatedly press and release the REMOTE start/stop (ON/OFF BUTTON). Briefly, further explain the Percussive Impactions (Bursts of Air) from the Mouthpiece.

Second, have the Patient actually start low amplitude Percussion by "puckering" the lips around the mouthpiece and holding the Remote Percussion Button depressed. Ask the Patient to breathe in and out of the Mouthpiece whenever he or she feels like taking a breath.

This is a critical point in the teaching of IPV®. More than likely the Patient will either not keep their lips tight around the Mouthpiece or they will let Air out of their Nose. Nasal "venting" must be stopped "NOW”. Nose Clips will "NOT” be used. Ask the Patient to more forcefully exhale through the Mouthpiece. Observe the Chest and look for a Percussive "shaking" as the Patient forcefully exhales. Keep repeating your exhale commands until a constant Percussion is noted by observing the Chest, during both the inspiratory and expiratory effort. If the Patient tires have them breathe Aerosol without Percussion for a minute or so, as you further explain "Nasal Venting".

Continue to Coach the Patient to Breathe through the Mouthpiece only, with the lips sealed comfortably around the Mouthpiece. If excessive "cheek flapping" is observed, ask the Patient to hold his cheeks by "puckering" a bit more. With proper training "nasal venting " can be resolved within very few minutes. Make certain the Patient is allowed to rest if stress is observed.

Check to see if the Patient is actually Percussing his or her Lungs, by looking at the Chest and observing a Percussive "shaking" on both sides from top to bottom. If the IPV® device does have a Proximal Airway Pressure Manometer the Needle should be Oscillating between 5-15 cm H2O. If Intrapulmonary Percussion is not observed revert to the basic teaching program.

When the Patient obligatorily has to cough or expectorate, the ON/OFF Button must be released. Do not obstruct a cough with a Mouthpiece.

The Leaking of Air through the Nose (Nasal Venting) is an initial problem with some Patients. If this event persists as indicated by failure to observe a Percussion (shaking chest), further Patient Coaching is required. One often effective method is to ask the Patient to "puff" in and out through the Mouthpiece, then relax and let the Percussionator® do the work, only taking a breath when desired. These commands can be repeated as necessary until total thoracic Percussion is observed.

NOTE: A Face Mask should only be used, if the patient "absolutely” can not master a mouthpiece.

After the mastering of nasal venting "cheek flapping" should be gradually concentrated upon.

During each Percussive Impaction, the Cheeks can absorb a considerable amount of the Percussive Energy, decreasing the Intrapulmonary Therapeutic Impaction. The Patient should be periodically reminded to "hold" his or her Cheeks firm.

The next Gateway is to teach the Patient control over the Therapeutic Interval. Simply hold the Button down for continuous Percussion, breathing in and out through the Percussion as desired. Release the Button when expectoration or a rest period is desired. This is the typical method which may be observed in Patients with Chronic Bronchitis, aggravated with Sub Clinical left congestive failure. This is NOT Harmful in any way. At this point a Patient may ask how often they can use IPV®? The answer is, as often as they desire, the same general IPV®/VDR® protocol is used to Ventilate Critical Care Patients for weeks at a time.

Remember to imprint upon the Patient, that they can Start or Stop Percussion any time they desire, by their total control over the Remote Percussion ON/OFF Switch. This is especially important when they feel as if they must cough or expectorate.

Initial rest periods of several minutes are acceptable as long as Aerosol is breathed while not Percussing.

After the Patient has mastered initial instructions and is performing well, the Amplitude of Percussion should be increased by increasing the Operational Pressure to 35-40 psig. This will provide a 10-15 cm H2O Needle Oscillation if a Manometer is used. Increasing the Percussive Operational Pressure increases the Impact Velocities at all Percussive rates. If Percussive Operational Pressures are too high (before the Patient has gained lip control over the Mouthpiece), leakage between the lips and the mouthpiece will be observed.

Therefore, slowly upgrade the Percussive Impaction forces. Ideally, a Percussive pressure selection should provide for an Intrapulmonary Wedge Pressure of about 5-10 cm H2O, which should be the ultimate goal after lip sealing fatigue is mastered. This will be scheduled with Operational Pressures of from 35-40 cm H2O with the PERCUSSION control knob Arrow under the 12:00 Index. Lip and Cheek control is similar to learning to play a Wind Instrument.

During the developmental years of Intrapulmonary Percussive Ventilation (IPV®), unique sine waves were studied to determine Impaction Forces which were compatible with "stretch receptors" (Hering Breuer) within the Lungs. With the advent of the Phasitron® physical/physiological converter, the proper Venturi Geometry for absolute fluid clutching was determined under Clinical conditions. The advent of the novel Phasitron® injector/exhalation valve was a major key in obtaining high levels of Clinical Efficacy.

While IPV® evolved from a long lineage of F. M. Bird conceived Pulmonary Care devices, the quest for determining a universal Calibration, evolved from a considerable data base. Essentially, IPV® is based upon a composite of High Density Aerosol Therapy, Volume oriented Intermittent Positive Pressure Breathing, CPAP and Chest Physiotherapy.

Note: A special Hydrophobic Filter is available to install in the (red) Manometric Pressure Sensing Tubing in IPV Devices employed for multiple Patient use.

PERCUSSIONAIRE EQUIPMENT CONDITION

Explain how IPV® Percussionators® and their accessories are kept clean?

All new Percussionaire® products are packaged clean. They should not be considered sterile or decontaminated. Prior to their use, it is recommended that breathing circuit components, Phasitron® and Aerosol Generator be disassembled and cleansed /decontaminated.

AVAILABLE ASEPTIC PROCEDURES

GAS STERILIZATION

Cold Ethylene Oxide (ETO) sterilization can be utilized for Percussionaire® respirators/ventilators. Percussionaire® breathing circuits and accessories may also be sterilized utilizing the ethylene oxide technique. IPV® components should not be exposed to temperatures in excess of 60°c (140° F).

Aeration times must be strictly observed as ETO is readily absorbed during the sterilization process. If an aerator is utilized, a forty-eight hour time period is required. If no aerator is used, equipment should not be placed in service for seven days.

COLD STERILIZATION

Liquid chemicals and cold sterilization are accepted methods of decontamination for all Percussionaire® breathing components and accessories. Most disinfectants are to be used only on inanimate objects and can cause damage to tissues. Equipment should be immersed according to manufacturers recommendations.

Equipment should be thoroughly rinsed then dried and packaged.

The mixing of the solutions and the techniques of decontamination should be based upon the instructions supplied by the manufacturer of the sterilizing solution.

Note: The respirators and monitoring equipment are not immersible.

PASTEURMATIC

Equipment sterilized utilizing the Pasteurmatic®, should be thoroughly rinsed prior to commencing the process. The cleaning cycle preset, should be 170°F. Equipment exposed to spores, fungus, tuberculosis etc. should be immersed in liquid chemicals following the manufacturers recommendations, prior to being sterilized in the Pasteurmatic.

The time period can be up to ten hours. Typical Non disposable anesthesia and respiratory equipment can tolerate repeated pasteurization without harm. Components should be assembled and packaged after cleaning process is completed.

STEAM AUTOCLAVE

Equipment sterilized utilizing a Steam Autoclave should be thoroughly rinsed prior to commencing process. The cleaning cycle is preset at 210°F.

Equipment exposed to the effects of spores should be immersed in liquid chemicals for a minimum of ten hours and rinsed prior to steam autoclaving.

Components should be assembled and packaged after the cleaning process is completed.

Steam autoclave can only be used on breathing head accessories not including semi-disposable tubing’s and certainly not the devices themselves.

Note: Do not autoclave multi-colored breathing harness.

SURFACE AREAS

The IPV® family of Percussionators® should be wiped down between patient use, with an institutionally approved disinfectant, compatible with thermoplastics.

Disinfectant solution should not be sprayed directly onto the IPV® devices. The solution should be sprayed onto a cloth then the cloth used to wipe the unit down.

The IPV® series of Respirator/Ventilators can be sterilized utilizing Ethylene Oxide Technique (ETO) cold cycle. Aeration time should be a minimum of forty-eight hours when utilizing the chamber and several additional days (ambient) prior to being placed back in use.

Note: Percussionaire® does not claim any responsibility for damage to their devices, secondary to aseptic procedures, because of the great variance in suggested techniques.

Note: Phasitron and Nebulizer must be completely disassembled for aseptic procedures.

How can I keep my Home Care IPV® Percussionators clean?

Self infection from home care Respiratory Therapy devices can be a REAL THREAT to the Patients well being. Therefore specific aseptic procedures must be adhered to by all Domiciliary Patients.

While a daily mechanical wash, if done well can be effective, a weekly soak can increase overall effectivity. Once each week, soak all Breathing Head components in a solution of white vinegar and water. One cup of white vinegar to a gallon of water is average. The following week alternate to a soak with a Chlorine Base solution such as Clorox® etc. Follow the chlorine base product manufacturer’s recommendations for an average household solution. After a twenty plus minute soak in the cleansing solution, rinse thoroughly in clean fresh water and dry.

NOTE: There are a number of excellent hospital approved cleansing solutions that can be alternatively employed in the home. Make certain that you obtain competent technical advise when alternative solutions are considered.

Percussionaire® can guarantee that its Breathing Head Components will have a potential for self infection if they are not maintained under clean conditions. All Breathing Equipment must be kept sparkling clean at all times. Cleansing must be a continual scheduled practice.

THE PHASITRON® DUO®, SEMI DISPOSABLE SINGLE PATIENT BREATHING HEAD ASSEMBLY, CAN BE MECHANICALLY PROCESSED WITH STANDARD ASEPTIC PROCEDURES. HOWEVER, ONLY COLD STERILIZATION TECHNIQUES CAN BE EMPLOYED. The PHASITRON® DUO®,BREATHING HEAD assembly can be reverse flushed during cleansing by removing the Nebulizer Bowl. Jet Chambers must be "purged of sterilizing solutions by flipping”. Internal Cavities can be positionally self drained.

BASIC TROUBLESHOOTING FOR THE IMPULSATOR®

If my Percussionator® doesn’t function properly what might I do?

PROBLEM: UNIT WILL NOT START

PROBLEM: UNIT HAS DELAYED STARTUP

PROBLEM: UNIT FAILS TO MAINTAIN PEAK INSPIRATORY PRESSURE

BRIEF SUMMARY OF IPV® WHEN EMPLOYED AS A COMBINATION VENTILATOR AND AIRWAY MOBILIZATION DEVICE

Explain the basic Clinical Functions and Justifications for IPV®?

1. During the Percussive Interval, IPV® maintains an Intrapulmonary Wedge Pressure serving to Stabilize the Airway Patency (size). With the maintenance of a mean (average) Wedge Pressure (mechanical obturator), a repetitive Percussive Pressure Change (through the Wedge Pressure) serves as a pneumatic Air Hammer to open obstructed Pulmonary Airways by Breaching retained Endobronchial Secretions etc.

2. After Airway Breaching and the delivery of air, Distal To the Endobronchial Obstructions, a basic mechanical means of endobronchial secretion mobilization begins.

3. Concomitant with mechanical airway dilation, an aerosolized topical vasoconstrictor, bronchodilator and secretion bond breaker, in the form of an aqueous Racemic Epinephrine, can be delivered in a Therapeutic Mist.

4. Alternatively, a Beta (bronchodilator) in a saline solution can be employed, without the vasoconstrictor properties of R.E. During the Percussive Therapeutic Interval, forceful pulsatile intrabronchial Impulses at the rate of 100 to 300 cycles per minute serve most effectively to mechanically mix (shake up) intrapulmonary gases and aerosol particles. The diffuse bilateral delivery and exchange of Respiratory Gases during Percussion, serves to provide a more effective Blood Gas Interface.

5. Intrapulmonary gas mixing is greatly enhanced during sustained Percussion. With an effective volume of Inspiratory Gases in the peripheral Pulmonary Structures, under pulsatile positive pressures, a major flow gradient to ambient from the distal Pulmonary Airways can be created. This peripheral air load when exhaled against Percussion serves to raise mobilized Secretions.

6. The greater the Pulsed passive Expiratory Flow Velocity, as compared to the progressive mechanically pulsed Inspiratory Flow Rates, the more effective the mechanical removal of retained Endobronchial Secretions.

7. Through the Vasoconstrictor (alpha) action of Racemic Epinephrine, the IPV® Aerosol Generator provides for a topical delivery of the Mist to reduce mucosal and sub mucosal edema, within the walls of the Pulmonary Airways. A secondary Bronchodilator (beta) action serves to reduce potential Bronchiolar Spasm of the smooth muscle of the Terminal Bronchioles.

8. Water employed as a diluent for the racemic epinephrine, serves to lower both adhesive and cohesive forces of the retained endobronchial secretions, thus serving as a bond breaking vehicle. Additionally, the osmotic pressures of water creates a rapid topical uptake of the active medications.

9. Therefore, IPV® serves as a medium to mechanically and chemically mobilize retained Endobronchial Secretions. This includes:
a) Maintaining and Percussing the Pulmonary Airways.
b) Delivering a Topical Aerosolized Vasoconstrictor, Bronchodilator and bond breaker to reduce Endobronchial congestion.
c) Enhancing Expiratory flow velocity for the Cephalad mobilization of retained Endobronchial Secretions.

10. It is well recognized, that Alveoli can not be ventilated through obstructed Airways. After Airway mobilization, Percussive IPV® programming increases the blood/gas interface, by mechanically mixing the Intrapulmonary Gases, to enhance both Oxygen and Carbon Dioxide Diffusion, as well as provide for periodic increased convective ventilation for CO2 Washout.

MECHANICAL VESICULAR PERISTALSIS

Briefly explain Mechanical Vesicular Peristalsis?

There are certain circulatory considerations, associated with intrathoracic percussion, which centers around the augmentation of intrathoracic "Physiological Vesicular Peristalsis” to the Bronchial and Pulmonary Circulations. Additionally IPV® can conceivably, when properly programmed, create a definitive Enhancement to the flow of Intrathoracic Lymph toward the Thoracic Duct. In other words, a potentially powerful mechanical” Lymph Pump” can be created by Intrapulmonary Percussive Ventilation employing (IPV®).

HOME CARE MAINTENANCE ON IPV® REGIMES

How is a Home Care Patient indoctrinated and maintained on Intrapulmonary Percussive Ventilation (IPV®)?

Unless the Patient or a responsible Guardian has received competent Medical Advice and is generally conversant with the overall logic of IPV, the therapeutic efficacy of the protocol might well be compromised.

Each Patient must be under ethical medical prescription with a defining follow-up program in effect. The device must be initially delivered and maintained by a responsible qualified Agency who will properly instruct the Patient and continue to oversee individual competence.

Unless the Patient employs the IPV® protocol in total compliance with recommended schedules, therapeutic efficacy can be less than optimal. Without maximum Clinical Efficacy, the Patient will be compromised and those who have endeavored to bring about an ethical Medical Protocol will be "handicapped”.

Therefore, if a deviation from the Clinical protocol is contemplated by the Patient, such as continuing to smoke, IPV® therapy should not be considered. By negating their own welfare, the Patient embarrasses everyone else associated with the program.

If you, a concerned party have read this document in context, a level of general overall understanding, relative to the IPV® protocol, should have been reached. It must be understood that this treatise has been directed toward those with a general Medical knowledge, which is possessed by several levels of interest, namely, the Physician, the Nurse, the Respiratory and/or Physical Therapist and all those involved in the Administration of the IPV® Clinical protocols. Most important the average Patient can find the answers to many pertinent questions he or she might have, relative to what IPV® Therapy is all about.

THIS DOCUMENT IS NOT ALL INCLUSIVE, ADDITIONAL DATA AND INFORMATION, AS WELL AS, CLINICAL RESTRICTIONS MAY BE FOUND IN ASSOCIATED OPERATIONAL MANUALS AND LABELING.

Where can Percussionaire be contacted?

I   intrapulmonary            a twenty year learning curve 1980-2000
P   percussive                    by PERCUSSIONAIRE® corporation
V   ventilation

Representante Exclusivo para o Brasil:

+Av. Washington Luís, 364 - Santos, SP, Brasil
( (013) 3234-1130 (Santos) ou (011) 274-2019 (São Paulo)
FAX: (013) 3236-6319

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