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Interfaces of Non-invasive Ventilation on Performance in Patients With Chronic Obstructive Pulmonary Disease (Exercise-NIV)

Primary Purpose

Chronic Obstructive Pulmonary Disease, Non Invasive Ventilation, Exercise, Aerobic

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Non invasive ventilation during exercise with facial or nasal mask.
Sponsored by
ADIR Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ADIR Association

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CWLT with facial mask

CWLT with nasal mask

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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).
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).
Blood pressure (mmHg) before and after every CWLT using electrical blood pressure device.
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).
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).
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).
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).
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).

Full Information

First Posted
May 30, 2016
Last Updated
January 8, 2019
Sponsor
ADIR Association
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1. Study Identification

Unique Protocol Identification Number
NCT02796599
Brief Title
Interfaces of Non-invasive Ventilation on Performance in Patients With Chronic Obstructive Pulmonary Disease
Acronym
Exercise-NIV
Official Title
Impact of Various Interfaces of Non-invasive Ventilation on Performance During Exercise in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ADIR Association

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Non Invasive Ventilation, Exercise, Aerobic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CWLT with facial mask
Arm Type
Experimental
Arm Description
This study has a cross-over design. Patients will achieve CWLT with non-invasive ventilation using facial or nasal mask in a randomised order.
Arm Title
CWLT with nasal mask
Arm Type
Experimental
Arm Description
This study has a cross-over design. Patients will achieve CWLT with non-invasive ventilation using facial or nasal mask in a randomised order.
Intervention Type
Device
Intervention Name(s)
Non invasive ventilation during exercise with facial or nasal mask.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Endurance time (Tlim, in second) during Constant Work Load Test (CWLT).
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Comfort of different masks using numerical scale (0-10) after exercising with noninvasive ventilation.
Description
The comfort of the different interfaces is assessed after every CWLT using numerical scale.
Time Frame
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.
Title
Dyspnea during CWLT using modified Borg Scale (0-10).
Description
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).
Time Frame
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.
Title
Exhaustion during CWLT using modified Borg Scale (0-10).
Description
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).
Time Frame
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.
Title
Heart rate (rpm) during CWLT using capnograph.
Description
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).
Time Frame
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.
Title
Blood pressure (mmHg) before and after every CWLT using electrical blood pressure device.
Time Frame
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.
Title
Oxygen saturation (SpO2, %) during CWLT using capnograph.
Description
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).
Time Frame
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.
Title
Transcutaneous carbon dioxide pressure (PtcCO2, mmHg) during CWLT using capnograph.
Description
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).
Time Frame
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.
Title
Respiratory rate (rpm) during CWLT with noninvasive ventilation using ventilator monitoring.
Description
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).
Time Frame
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.
Title
Inspiratory tidal volume (Vti, in liter) during CWLT with noninvasive ventilation using ventilator monitoring.
Description
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).
Time Frame
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.
Title
Leak (liter per minute) during CWLT with noninvasive ventilation using ventilator monitoring.
Description
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).
Time Frame
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 Pre-specified Outcome Measures:
Title
Ventilatory asynchronism during CWLT with noninvasive ventilation using ventilator monitoring.
Description
Outcome will be continuously recorded.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Viacroze, MD
Organizational Affiliation
CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Catherine Tardif, MD
Organizational Affiliation
CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David Debeaumont, MD
Organizational Affiliation
CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jean-François Muir, Prof, PhD
Organizational 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
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tristan Bonnevie, PT, MsC
Organizational Affiliation
ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francis-Edouard Gravier, PT
Organizational Affiliation
ADIR Association, Bois-Guillaume, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Clément Médrinal, PT, MsC
Organizational 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
Official's Role
Study Chair
Facility Information:
Facility Name
ADIR Association
City
Bois-Guillaume
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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