COPD
Conditions
Keywords
COPD
Brief 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.
Interventions
DEVICEBipap (Respironics, Inc)
Bipap every night pressure at 15/5 with heated humidifier
Sponsors
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* stable chronic obstructive pulmonary disease (COPD) defined as forced expiratory volume in the first second (FEV1)/forced vital capacity (FVC) ratio of \<0.70, with at least 10 pack-years smoking history
Exclusion criteria
* congestive heart failure, obstructive sleep apnea, chronic respiratory conditions other than COPD, age \< 35 years, any disease limiting life expectancy to less than two years, active malignancy other than non-melanotic skin cancer in the previous two years, and with any anatomic variation or disease process that precluded wearing a nasal mask
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRDQ | 6 months | Chronic Respiratory Disease Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-minutes walk test | 6 months | Walking distances in feet |
| TDI | 6 months | Transitional Dyspnea Index |
| PO2 | 6 months | Oxygenation |
| NIF | 6 months | Negative Inspiratory force |
Other
| Measure | Time frame | Description |
|---|---|---|
| Side effect questionnaire | 6 months | Side effects with mask use |
Countries
United States
Outcome results
None listed