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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02796599
Other study ID # Exercise-NIV
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date February 2018

Study information

Verified date January 2019
Source ADIR Association
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date February 2018
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Device:
Non 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.

Locations

Country Name City State
France ADIR Association Bois-Guillaume

Sponsors (1)

Lead Sponsor Collaborator
ADIR Association

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Ventilatory asynchronism during CWLT with noninvasive ventilation using ventilator monitoring. Outcome will be continuously recorded. 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.
Primary 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 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
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