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

NCT ID: NCT02796599

Last Updated: 2019-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease Non Invasive Ventilation Exercise, Aerobic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Non invasive ventilation during exercise with facial or nasal mask.

Intervention Type 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 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.

Group Type EXPERIMENTAL

Non invasive ventilation during exercise with facial or nasal mask.

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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%)


* Pregnant woman or likely to be
* Familiar with home non-invasive ventilation
* Patient under guardianship

Exclusion Criteria

* Acute exacerbation of chronic obstructive pulmonary disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ADIR Association

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Catherine Viacroze, MD

Role: PRINCIPAL_INVESTIGATOR

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

Catherine Tardif, MD

Role: STUDY_CHAIR

CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France

David Debeaumont, MD

Role: STUDY_CHAIR

CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France

Jean-François Muir, Prof, PhD

Role: STUDY_CHAIR

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

Tristan Bonnevie, PT, MsC

Role: STUDY_CHAIR

ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France

Francis-Edouard Gravier, PT

Role: STUDY_CHAIR

ADIR Association, Bois-Guillaume, France

Clément Médrinal, PT, MsC

Role: STUDY_CHAIR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ADIR Association

Bois-Guillaume, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Exercise-NIV

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.