High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV)

Study Overview
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Brief Summary
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The purpose of this pilot study is to evaluate the effect of high intensity non-invasive positive pressure ventilation (HINPPV) for stable, hypercapnic COPD patients. The investigators believe that HINPPV, used at least 6 hours nocturnally over three months, will benefit the stable hypercapnic COPD patient through a reduction in the daytime partial pressure of carbon dioxide in arterial blood (PaCO2) levels.

Detailed Description
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The High Intensity Non-invasive Positive Pressure trial is a single arm interventional study. The purpose of this study is to evaluate the effect of High Intensity Non-invasive ventilation (HINPPV) in stable Chronic Obstructive Pulmonary patients with chronically elevated carbon dioxide levels. Participants will undergo various testing ( arterial blood gas (ABG), Pulmonary Function Test (PFTs), Polysomnography (PSGs), 6 minute walk tests)over a 3 month period to determine if this type of therapy will improve daytime carbon dioxide levels. The participants will also complete quality of life questionnaires to help ascertain improvements in their daily living activities.

Official Title
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High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV) for Stable Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Device: Bilevel positive airway pressure (BiPAP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patient diagnosed with chronic obstructive pulmonary disease (COPD) Age < or = to 80 years Forced expiratory volume in one second (FEV1) < 50% of predicted value FEV1/Forced vital capacity (FVC) < 70% of predicted value Total lung capacity (TLC) > 90% predicted by plethysmography Body Mass Index (BMI) < 35 Patient has provided written informed consent using a form that has been approved by the Internal Review Board (IRB) Daytime PaCO2 ≥ 52 mm Hg, at rest on room air (Denver > 48 mm Hg) with one of the following symptoms of hypercapnia: Fatigue Sleepiness Headaches Post hospital discharge at least one month prior to screening visit Participant is willing and able to complete all required assessments and procedures Participant has no child bearing potential OR a negative pregnancy test in a woman of childbearing potential Exclusion Criteria FEV1 < 15% of predicted value Diagnosis of obstructive sleep apnea (OSA) [Apnea hypopnea index (AHI) > 15 per hour] Current Non-invasive Positive Pressure Ventilation (NIPPV), Positive Airway Pressure (PAP) or Non-invasive Ventilation (NIV) users Signs / symptoms of acute exacerbation within the previous month: two of the following criteria: Increasing cough Purulent sputum Current use of antibiotics pH < 7.35 Any major non COPD disease or condition that interferes with completion of initial or follow-up assessments, such as uncontrolled malignancy, end-stage heart disease, liver or renal insufficiency (that requires current evaluation for liver or renal transplantation or dialysis), amyotrophic lateral sclerosis, or severe stroke, or other as deemed appropriate by investigator as determined by review of medical history and / or patient reported medical history History of pneumothorax Anatomical facial abnormalities precluding placement of a nasal or facial mask Diffuse parenchymal lung disease other than emphysema Inability to maintain Oxygen (O2) saturation >90% on 5L/min ( five liters) nasal O2 at rest Sustained need for >10 mg prednisone daily or equivalent dose of other systemic corticosteroid Pregnancy Excessive alcohol intake (≥ 6oz hard liquor daily), or illicit drug use Daily use of narcotics (greater than 30 mg morphine equivalent) Patient is currently enrolled in another interventional clinical trial

Ages Eligible for Study
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Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity Non Invasive Pos.Pressure<br>The High Intensity Non-invasive Pos.Pressure trial is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive high intensity non-invasive positive pressure ventilation (HINPPV) for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O (centimeters of water); or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O. | Device: Bilevel positive airway pressure (BiPAP)<br>* This is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive high intensity non-invasive positive pressure ventilation(HINPPV). Participants will receive HINPPV via bilevel positive airway pressure (BiPAP) via a Synchrony ventilator if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O; or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.<br>* Other names: Synchrony BiPAP ventilator and Trilogy Ventilator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2) | Daytime PaCO2 levels assessed after using high intensity non-invasive positive pressure ventilation (HINPPV) are compared to the participants' baseline daytime PaCO2 levels. | Before and after 3 months of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Status | Health status was assessed by completing different surveys at baseline and after 3 months of therapy. The Calgary Sleep Apnea Quality of Life was administered at baseline and 3 months. It is a 35-item, interview-administered scale, the SAQLI evaluates four domains of quality of life associated with sleep apnea: daily functioning, social interactions, emotional functioning, and symptoms. The SAQLI use a 7-point Likert scale ranging from 1 (maximal impairment) to 7 (no impairment). | Before and after 3 months of therapy | 
| Maximal Inspiratory Pressure | The Maximal inspiratory pressure (MIP) is the maximum negative pressure that can be generated from one inspiratory effort starting from functional residual capacity (FRC) or residual volume (RV). This was assessed at baseline and after 3 months of therapy. | Before and after 3 months of therapy | 
| Exercise Capacity | Exercise capacity will be measured by comparing the 6 minute walk test as measured in meters from baseline to 3 months | Before and after 3 months of therapy | 
| Dyspnea at Rest and With Exertion | The modifed Borg scale was used to measure dyspnea. The Dyspnea Borg scale measures patients perceived level of dyspnea. The scale ranges from 0 to 10, 0- nothing at all and 10 is maximal. | Before and after 3 months of therapy | 
| Sleepiness | Sleepiness will be evaluated by measuring the the baseline and 3 month Epworth Sleepiness Scale. The Epworth Sleepiness Scale is an 8 question survey regarding daytime sleepiness. The higher the score the higher the chance of dozing during the day. Each question is rated on a 0 to 3 scale of chance of dozing or sleeping. 0 would be no chance, 3 would be the highest chance. | Before and after 3 months of therapy | 
| Duration of Sleep | Duration of sleep will be measured using total sleep time. Total sleep time is the overall number of minutes of sleep, this will be compared from baseline to 3 months. | Before and after 3 months of therapy | 
| Efficiency of Sleep | Sleep efficiency will be measured by taking the total sleep time by the total time in bed. This is measured as a percentage and compared from baseline to 3 months | Before and after 3 months of therapy |