N/A
N=20
High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV)
Chronic Obstructive Pulmonary Disease (COPD)
Bottom Line
View on ClinicalTrials.gov: NCT01214200 ↗Enrolled (actual)
20
Serious AEs
44.4%
Results posted
Jan 2019
Primary outcome: Primary: Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2) — 53; 50 mmHg — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bilevel positive airway pressure (BiPAP) (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Philips Respironics
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2) |
53; 50 | 0.01 sig |
| SECONDARY Health Status |
4.34; 4.78 | — |
| SECONDARY Maximal Inspiratory Pressure |
7.04; 6.85 | — |
| SECONDARY Exercise Capacity |
211; 236 | — |
| SECONDARY Dyspnea at Rest and With Exertion |
0.7; 6.9; 0.6; 4.6 | — |
| SECONDARY Sleepiness |
9.3; 7.2 | — |
| SECONDARY Duration of Sleep |
329; 337 | — |
| SECONDARY Efficiency of Sleep |
80.6; 83.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patient diagnosed with chronic obstructive pulmonary disease (COPD)
- Age 90% predicted by plethysmography
- Body Mass Index (BMI) 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 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 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
Data sourced from ClinicalTrials.gov (NCT01214200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.