N/A Completed N=20 Treatment

High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV)

Chronic Obstructive Pulmonary Disease

Source: ClinicalTrials.gov NCT01214200 ↗

Enrolled (actual)

Serious AEs

44.4%

Results posted

Jan 2019

Primary outcomePrimary: Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2) — 53; 50 mmHg — p=0.01

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.