Clinical trial NCT02796599: Interfaces of Non-invasive Ventilation on Performance in Patients With Chronic Obstructive Pulmonary Disease
Official title: Impact of Various Interfaces of Non-invasive Ventilation on Performance During Exercise in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Non Invasive Ventilation
Exercise, Aerobic
Lead sponsor: ADIR Association
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Endurance time (Tlim, in second) during Constant Work Load Test (CWLT).
timeFrame: 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 outcomes:
measure: Comfort of different masks using numerical scale (0-10) after exercising with noninvasive ventilation.
timeFrame: 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.
measure: Dyspnea during CWLT using modified Borg Scale (0-10).
timeFrame: 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.
measure: Exhaustion during CWLT using modified Borg Scale (0-10).
timeFrame: 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.
measure: Heart rate (rpm) during CWLT using capnograph.
timeFrame: 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.
measure: Blood pressure (mmHg) before and after every CWLT using electrical blood pressure device.
timeFrame: 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.
measure: Oxygen saturation (SpO2, %) during CWLT using capnograph.
timeFrame: 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.
measure: Transcutaneous carbon dioxide pressure (PtcCO2, mmHg) during CWLT using capnograph.
timeFrame: 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.
measure: Respiratory rate (rpm) during CWLT with noninvasive ventilation using ventilator monitoring.
timeFrame: 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.
measure: Inspiratory tidal volume (Vti, in liter) during CWLT with noninvasive ventilation using ventilator monitoring.
timeFrame: 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.
measure: Leak (liter per minute) during CWLT with noninvasive ventilation using ventilator monitoring.
timeFrame: 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.
Other outcomes:
measure: Ventilatory asynchronism during CWLT with noninvasive ventilation using ventilator monitoring.
timeFrame: 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.
Locations:
city: Bois-Guillaume
country: France
facility: ADIR Association
Study officials:
affiliation: CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
name: Catherine Viacroze, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
name: Catherine Tardif, MD
role: STUDY_CHAIR
affiliation: CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
name: David Debeaumont, MD
role: STUDY_CHAIR
affiliation: CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; ADIR Association, Bois-Guillaume, France
name: Jean-François Muir, Prof, PhD
role: STUDY_CHAIR
affiliation: ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
name: Tristan Bonnevie, PT, MsC
role: STUDY_CHAIR
affiliation: ADIR Association, Bois-Guillaume, France
name: Francis-Edouard Gravier, PT
role: STUDY_CHAIR
affiliation: UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France. Service de réanimation, Groupe Hospitalier du Havre, France
name: Clément Médrinal, PT, MsC
role: STUDY_CHAIR
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