High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV) for Stable Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Sponsor
- Philips Respironics
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)
Time Frame: Before and after 3 months of therapy
Daytime PaCO2 levels assessed after using high intensity non-invasive positive pressure ventilation (HINPPV) are compared to the participants' baseline daytime PaCO2 levels.
Secondary Outcomes
- Exercise Capacity(Before and after 3 months of therapy)
- Dyspnea at Rest and With Exertion(Before and after 3 months of therapy)
- Maximal Inspiratory Pressure(Before and after 3 months of therapy)
- Efficiency of Sleep(Before and after 3 months of therapy)
- Health Status(Before and after 3 months of therapy)
- Sleepiness(Before and after 3 months of therapy)
- Duration of Sleep(Before and after 3 months of therapy)