exertional hypoxemic COPD
Conditions
Interventions
Ventilation and oxygen support during exercise.
Sponsors
Philips Group Innovation - Research,
High Tech Campus 34
5656 AE Eindhoven, The Netherlands
Eligibility
Inclusion criteria
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 8.0 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
Exclusion criteria: Exclusion criteria for subject selection 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..
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the present study is to investigate whether or not patients with COPD with normal blood gases and static hyperinflation at rest, but hemoglobin oxygen desaturation during exercise have beneficial effects of continuous or intermittent oxygen therapy combined with bilevel positive pressure non-invasive ventilation, in terms of time to recovery after exercise and duration of continuation of exercise after recovery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective of the study is to compare the intermittent use of oxygen and bilevel positive pressure non-invasive ventilation to continuous use, in terms of time to recovery after exercise and duration of continuation of exercise after recovery Additional secondary objectives of the study are to investigate whether or not the interventions described in the primary objective have beneficial effects on heart rate, heart rate recovery, exercise induced oxygen desaturation, exercise induced changes in transcutaneous measured pCO2, changes in breathing frequency, dynamic hyperinflation, dyspnea scores, leg discomfort. | — |
Contacts
Public ContactDenny Mathew
Philips Research,
Outcome results
None listed