Chronic Obstructive Pulmonary Disease, Exercise, Aerobic, Non Invasive Ventilation
Conditions
Brief summary
The purpose of this study is to determine wether the interface (facial or nasal mask) influences performance in patients with chronic obstructive pulmonary disease exercising with non-invasive ventilation.
Interventions
DEVICENon invasive ventilation during exercise with facial or nasal mask.
Every patients will achieve 3 constant work load test (CWLT) at 75% Wpic. The first CWLT will be realized without any ventilatory support. The 2 others CWLT will be achieved with non-invasive ventilation support using facial or nasal interface in a randomized order.
Sponsors
ADIR Association
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Chronic obstructive pulmonary disease Gold III-IV * Eligible for pulmonary rehabilitation * Exercise limitation : at least respiratory limitation (ventilatory reserve ≤ 30%) Non-inclusion Criteria: * Pregnant woman or likely to be * Familiar with home non-invasive ventilation * Patient under guardianship
Exclusion criteria
* Acute exacerbation of chronic obstructive pulmonary disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endurance time (Tlim, in second) during Constant Work Load Test (CWLT). | The outcome will be measure after every CWLT. The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. | Patients will achieve 3 Constant Work Load Test Under different conditions (1 without noninvasive ventilation and 2 with noninvasive ventilation using in a randomised order facial or nasal mask). Endurance time (sec) will be recorded at the end of every test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comfort of different masks using numerical scale (0-10) after exercising with noninvasive ventilation. | The outcome will be measure after every CWLT achieved with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. | The comfort of the different interfaces is assessed after every CWLT using numerical scale. |
| Dyspnea during CWLT using modified Borg Scale (0-10). | The outcome will be measure during every CWLT.The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be collected every 30s during tests. | The dyspnea will be assessed every 30sec during CWLT. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test). |
| Exhaustion during CWLT using modified Borg Scale (0-10). | The outcome will be measure during every CWLT.The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be collected every 30s during tests. | The exhaustion will be assessed every 30sec during CWLT. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test). |
| Heart rate (rpm) during CWLT using capnograph. | The outcome will be measure during every CWLT (with or without noninvasive ventilation).The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected. | Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test). |
| Blood pressure (mmHg) before and after every CWLT using electrical blood pressure device. | The outcome will be assessed before and after every CWLT. The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. | — |
| Transcutaneous carbon dioxide pressure (PtcCO2, mmHg) during CWLT using capnograph. | The outcome will be measure during every CWLT (with or without noninvasive ventilation).The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected. | Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test). |
| Respiratory rate (rpm) during CWLT with noninvasive ventilation using ventilator monitoring. | The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. | Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 2 tests) and iso time (defined as the Tlim or the shortest test). |
| Inspiratory tidal volume (Vti, in liter) during CWLT with noninvasive ventilation using ventilator monitoring. | The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. | Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 2 tests) and iso time (defined as the Tlim or the shortest test). |
| Leak (liter per minute) during CWLT with noninvasive ventilation using ventilator monitoring. | The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. | Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 2 tests) and iso time (defined as the Tlim or the shortest test). |
| Oxygen saturation (SpO2, %) during CWLT using capnograph. | The outcome will be measure during every CWLT (with or without noninvasive ventilation).The 3 CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. Data will be continuously collected. | Outcome will be continuously recorded. Results will be shown at Tlim (Tlim for the 3 tests) and iso time (defined as the Tlim or the shortest test). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ventilatory asynchronism during CWLT with noninvasive ventilation using ventilator monitoring. | The outcome will be measure during CWLT with noninvasive ventilation. CWLT will be carried out in different days, separate from 1 day minimum for a total time frame of 2 weeks maximum. | Outcome will be continuously recorded. |
Countries
France
Outcome results
None listed