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…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
chronic obstructive pulmonary disease (COPD)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
The project is aimed to evaluate new opportunities for oxygen therapy/delivery
for COPD management and the project is conducted with close consultation with
Home respiratory care business. A detailed literature study is conducted for
identifying the clinical needs of COPD patients and various Oxygen therapies
[such as long term oxygen therapy, ambulatory oxygen therapy, short burst
oxygen therapy] used in COPD management, which helps to relieve the symptoms
such as breathlessness. And, the current study addresses one of the
opportunity to move upstream from very severe to patients to
less-severe/moderate patients and could be considered as a pilot study prior to
a large clinical study.
Study objective
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.
Study design
A longitudinal, single blind, sham controlled, cross-over pilot study with 20
patients. This design was chosen to investigate the beneficial effects of the
interventions compared to the sham situation in the individual patient..
Intervention
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 ventilation support during six minute
walk test.
Study burden and risks
There are no anticipated adverse device effects. Residual risks associated with
investigational device are only minimal as we will only use CE marked devices
within their intended purpose, and make use of an application expert for set up
and instruction. A combination of continuous positive air pressure during
ventilation in combination with supplemental oxygen is expected to improve the
exercise capacitance in these patients and probably also their recovery from
exertion. These benefits outweigh the minimal risks associated with the
treadmill walking tests.
High Tech Campus 34
Eindhoven 5656 AE
NL
High Tech Campus 34
Eindhoven 5656 AE
NL
Listed location countries
Age
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..
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL54204.100.15 |