Clinical Trials Directory

Trials / Completed

CompletedNCT01722773

Trial of Non-invasive Ventilation for Stable COPD

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
University of Iowa · Academic / Other
Sex
All
Age
35 Years
Healthy volunteers
Not accepted

Summary

The use of domiciliary non-invasive positive pressure ventilation (NPPV) in stable chronic obstructive pulmonary disease (COPD) with chronic hypercapnic respiratory failure has yielded variable effects on survival, quality of life and dyspnea. The investigators hypothesized that use of NPPV in stable COPD might result in improvement in quality of life and dyspnea.

Detailed description

Chronic obstructive pulmonary disease (COPD) is associated with progressive decline in lung function with resultant chronic respiratory failure. This leads to significant rates of hospitalization, disability, and death. COPD is also associated with sleep disordered breathing and nocturnal hypoventilation, resulting in nocturnal and daytime hypoxemia and hypercapnia. These, in turn, can contribute to fatigue, dyspnea and impaired quality of life. Presence of hypercapnia is associated with a 33% 5-year survival. Nocturnal NPPV can theoretically rest overloaded respiratory muscles, prevent nocturnal hypoventilation, and reset central respiratory drive in patients with hypercapnia. The use of non-invasive positive pressure ventilation (NPPV) in late stage COPD appears logical to change this inexorable course, to alleviate symptoms and to improve quality of life. While NPPV has a definite role in the management of acute hypercapnic respiratory failure, its role in the management of late stage stable COPD is controversial. Multiple studies have shown no survival benefit for nocturnal NPPV in chronic hypercapnic stable COPD patients. The effects on quality of life and dyspnea scores in such patients have been inconsistent. The variable efficacy might have been due to late administration of the intervention in the course of disease, in the presence of advanced hypercapnic respiratory failure. We sought to assess the effect of applying NPPV on indices of health-related quality of life in patients with relative normocapnia. We hypothesized that patients with stable severe COPD have improved quality of life and reduced dyspnea with the use of NPPV.

Conditions

Interventions

TypeNameDescription
DEVICEBipap (Respironics, Inc)Bipap every night pressure at 15/5 with heated humidifier

Timeline

Start date
2001-04-01
Primary completion
2004-04-01
Completion
2004-04-01
First posted
2012-11-07
Last updated
2012-11-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01722773. Inclusion in this directory is not an endorsement.