Chronic Obstructive Pulmonary Disease Clinical Trial
— Exercise-NIVOfficial title:
Impact of Various Interfaces of Non-invasive Ventilation on Performance During Exercise in Patients With Chronic Obstructive Pulmonary Disease
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 |
Verified date | January 2019 |
Source | ADIR Association |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | ADIR Association | Bois-Guillaume |
Lead Sponsor | Collaborator |
---|---|
ADIR Association |
France,
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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