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

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ClinicalTrials.gov Identifier: NCT02796599
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
ADIR Association

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Non Invasive Ventilation Exercise, Aerobic Device: Non invasive ventilation during exercise with facial or nasal mask. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Various Interfaces of Non-invasive Ventilation on Performance During Exercise in Patients With Chronic Obstructive Pulmonary Disease
Study Start Date : June 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. Endurance time (Tlim, in second) during Constant Work Load Test (CWLT). [ 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. ]
    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 :
  1. Comfort of different masks using numerical scale (0-10) after exercising with noninvasive ventilation. [ 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. ]
    The comfort of the different interfaces is assessed after every CWLT using numerical scale.

  2. Dyspnea during CWLT using modified Borg Scale (0-10). [ 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. ]
    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).

  3. Exhaustion during CWLT using modified Borg Scale (0-10). [ 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. ]
    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).

  4. Heart rate (rpm) during CWLT using capnograph. [ 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. ]
    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).

  5. 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. ]
  6. Oxygen saturation (SpO2, %) during CWLT using capnograph. [ 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. ]
    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).

  7. Transcutaneous carbon dioxide pressure (PtcCO2, mmHg) during CWLT using capnograph. [ 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. ]
    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).

  8. Respiratory rate (rpm) during CWLT with noninvasive ventilation using ventilator monitoring. [ 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. ]
    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).

  9. Inspiratory tidal volume (Vti, in liter) during CWLT with noninvasive ventilation using ventilator monitoring. [ 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. ]
    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).

  10. Leak (liter per minute) during CWLT with noninvasive ventilation using ventilator monitoring. [ 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. ]
    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).


Other Outcome Measures:
  1. Ventilatory asynchronism during CWLT with noninvasive ventilation using ventilator monitoring. [ 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. ]
    Outcome will be continuously recorded.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796599


Locations
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France
ADIR Association
Bois-Guillaume, France
Sponsors and Collaborators
ADIR Association
Investigators
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Principal Investigator: Catherine Viacroze, MD CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
Study Chair: Catherine Tardif, MD CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Study Chair: David Debeaumont, MD CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Study Chair: Jean-François Muir, Prof, PhD 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
Study Chair: Tristan Bonnevie, PT, MsC ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
Study Chair: Francis-Edouard Gravier, PT ADIR Association, Bois-Guillaume, France
Study Chair: Clément Médrinal, PT, MsC 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

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Responsible Party: ADIR Association
ClinicalTrials.gov Identifier: NCT02796599     History of Changes
Other Study ID Numbers: Exercise-NIV
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases