Interfaces of Non-invasive Ventilation on Performance in Patients With Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Various Interfaces of Non-invasive Ventilation on Performance During Exercise in Patients With Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease, Non Invasive Ventilation, Exercise, Aerobic

Intervention / Treatment
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* Device: Non invasive ventilation during exercise with facial or nasal mask.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CWLT with facial mask<br>This study has a cross-over design. Patients will achieve CWLT with non-invasive ventilation using facial or nasal mask in a randomised order. | Device: Non invasive ventilation during exercise with facial or nasal mask.<br>* 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.<br>|
| Experimental: CWLT with nasal mask<br>This study has a cross-over design. Patients will achieve CWLT with non-invasive ventilation using facial or nasal mask in a randomised order. | Device: Non invasive ventilation during exercise with facial or nasal mask.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endurance time (Tlim, in second) during Constant Work Load Test (CWLT). | 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. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort of different masks using numerical scale (0-10) after exercising with noninvasive ventilation. | The comfort of the different interfaces is assessed after every CWLT using numerical scale. | 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. | 
| Dyspnea during CWLT using modified Borg Scale (0-10). | 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). | 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. | 
| Exhaustion during CWLT using modified Borg Scale (0-10). | 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). | 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. | 
| Heart rate (rpm) during CWLT using capnograph. | 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). | 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. | 
| 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. | 
| Oxygen saturation (SpO2, %) during CWLT using capnograph. | 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). | 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. | 
| Transcutaneous carbon dioxide pressure (PtcCO2, mmHg) during CWLT using capnograph. | 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). | 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. | 
| Respiratory rate (rpm) during CWLT with noninvasive ventilation using ventilator monitoring. | 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). | 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. | 
| Inspiratory tidal volume (Vti, in liter) during CWLT with noninvasive ventilation using ventilator monitoring. | 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). | 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. | 
| Leak (liter per minute) during CWLT with noninvasive ventilation using ventilator monitoring. | 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). | 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. |