A study to investigate intermittent and continuous oxygen and ventilation support during physical activity in exertional hypoxemic COPD patients

Recruiting

Conditions: chronic obstructive pulmonary disease (COPD)

Registration Number: NL-OMON43753

Lead Sponsor: Philips

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 13

Inclusion Criteria

Subjects eligible for participation should meet the following criteria:
1. Patients with a diagnosis of COPD, which is spirometrically confirmed with FEV1/FVC ratio below 0.7 and staged as GOLD 2 or higher, which is FEV1 < 80% of predicted according to validated reference values.
2. Age between 40 and 80 years.
3. No hypoxia requiring long term oxygen treatment and no hypercapnia. Normal blood gases are defined as pO2 levels * 7.3 kPa and pCO2 levels below 6.5 kPa.
4. Pulseoxymetre measured hemoglobin oxygen desaturation during 6 minute walking distance below 88%.
5. Presence of static hyperinflation, measured as an increase in residual volume > 150% of predicte values according to validated reference values.
6. Stable state COPD, which is free from exacerbations or respiratory infections for at least two weeks.
7. Signed informed consent.

Exclusion Criteria

Subjects eligible for participation should not meet the following criteria:
1. Active malignancy
2. Previous pulmonary surgery
3. Unstable cardiovascular disease as unstable coronary artery disease, heartfailure or claudicatio intermittens as these might infere with the safety of the exercise.
4. Orthopedic problems that interfere with walking tests
5. Use of walking aids or wheel chair
6. Contraindications for use of non-invasive ventilation: acute sinusitis or otitis media, low blood pressure, inability to adequately clear secretions, etc..

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To investigate whether or not COPD patients with normal blood gases and static<br /><br>hyperinflation at rest, but hemoglobin oxygen desaturation during exercise have<br /><br>beneficial effects of continuous or intermittent oxygen therapy combined with<br /><br>bilevel positive pressure non-invasive ventilation, in terms of time to<br /><br>recovery after exercise and duration of continuation of exercise after<br /><br>recovery. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objective of the study is to compare the intermittent use of oxygen<br /><br>and bilevel positive pressure non-invasive ventilation to continuous use, in<br /><br>terms of time to recovery after exercise and duration of continuation of<br /><br>exercise after recovery.<br /><br><br /><br>Additional secondary objectives of the study are to investigate whether or not<br /><br>the interventions described in the primary objective have beneficial effects on<br /><br>heart rate, heart rate recovery, exercise induced oxygen desaturation, exercise<br /><br>induced changes in transcutaneously measured pCO2, changes in breathing<br /><br>frequency, dynamic hyperinflation, dyspnea scores, leg discomfort. </p><br>