chronic obstructive pulmonary disease (COPD) chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
A commercially available CE certified Philips-Respironics V60 ventilator,
connected to a wall supply of Oxygen will be used to provide the COPD patient
with combined supplemental oxygen and ventilat
Sponsors
Philips
Eligibility
Age
18 Years to 99 Years
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 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: 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 |
|---|---|
| To investigate whether or not COPD patients 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 transcutaneously measured pCO2, changes in breathing frequency, dynamic hyperinflation, dyspnea scores, leg discomfort. | — |
Countries
Netherlands
Outcome results
None listed