NCT02796599

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

1.7 years

First QC Date

May 30, 2016

Last Update Submit

January 8, 2019

Conditions

Chronic Obstructive Pulmonary DiseaseNon Invasive VentilationExercise, Aerobic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Comfort of different masks using numerical scale (0-10) after exercising with noninvasive ventilation.

    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.

  • Dyspnea during CWLT using modified Borg Scale (0-10).

    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.

  • Exhaustion during CWLT using modified Borg Scale (0-10).

    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.

  • Heart rate (rpm) during CWLT using capnograph.

    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.

  • 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.

  • +5 more secondary outcomes

Other Outcomes (1)

  • Ventilatory asynchronism during CWLT with noninvasive ventilation using ventilator monitoring.

    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.

Study Arms (2)

CWLT with facial mask

EXPERIMENTAL

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.

CWLT with nasal mask

EXPERIMENTAL

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.

Interventions

Non invasive ventilation during exercise with facial or nasal mask.DEVICE

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.

CWLT with facial maskCWLT with nasal mask

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Chronic obstructive pulmonary disease Gold III-IV
  • Eligible for pulmonary rehabilitation
  • Exercise limitation : at least respiratory limitation (ventilatory reserve ≤ 30%)
  • Pregnant woman or likely to be
  • Familiar with home non-invasive ventilation
  • Patient under guardianship

You may not qualify if:

  • Acute exacerbation of chronic obstructive pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ADIR Association

Bois-Guillaume, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Catherine Viacroze, MD

    CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2016

First Posted

June 10, 2016

Study Start

June 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

January 9, 2019

Record last verified: 2019-01

Locations

FR(1)