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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Exercise, Aerobic; Non Invasive Ventilation
• Interventions: Device: Non invasive ventilation during exercise with facial or nasal mask.

• Registration Number: NCT02796599
• Lead Sponsor: ADIR Association

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-30
• Study Start: 2016-06
• Study First Submitted QC: 2016-06-09
• Study First Posted: 2016-06-10
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CWLT with nasal mask	Non invasive ventilation during exercise with facial or nasal mask.	This study has a cross-over design. Patients will achieve CWLT with non-invasive ventilation using facial or nasal mask in a randomised order.
CWLT with facial mask	Non invasive ventilation during exercise with facial or nasal mask.	This study has a cross-over design. Patients will achieve CWLT with non-invasive ventilation using facial or nasal mask in a randomised order.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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).
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).
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).
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.
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.
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).
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).
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).

Trial Locations

Locations (1)

ADIR Association; 🇫🇷 Bois-Guillaume, France