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

Chronic Obstructive Pulmonary Disease Clinical Trial

— Exercise-NIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796599
• Other study ID #: Exercise-NIV
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Exercise, Aerobic
• Lung Diseases
• Lung Diseases, Obstructive
• Non Invasive Ventilation
• Pulmonary Disease, Chronic Obstructive

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.