Prevalence and Risk Factors of Reventilation Syndrome in a Population of Patients Under Ventilation for Whatever Reason

NCT ID: NCT02851446

Last Updated: 2016-08-02

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

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Brief Summary

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Non-invasive nocturnal ventilation is an effective treatment for chronic respiratory failure, whether due to obstructive (COPD), restrictive or neuromuscular causes, notably for patients in the last two categories for whom it significantly prolongs life expectancy. Overall, the treatment is well tolerated, its principal adverse effects being discomfort related to the mask.

In certain patients, morning dyspnoea when the mask is removed has been described. This is disabling as it limits everyday activities for at least 30 minutes, and defines deventilation syndrome. The pathophysiology of this syndrome is uncertain, notably the roles of hyperinflation, patient/ventilator asynchrony, or the sudden increase in diaphragmatic work after a night of rest.

The aim of this study is to investigate the prevalence of and factors associated with reventilation syndrome (DS) in a population of patients with ventilation whatever the reason, in a stable state, and followed by the medical devices department of Dijon CHU, so as to better understand the mechanisms. Patients with DS will subsequently be invited to participate in a therapeutic trial.

Detailed Description

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Conditions

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Prevalence of and Factors Associated With Reventilation Syndrome (DS)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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DS

measure dyspnoea> Borg 7

Intervention Type OTHER

no DS

measure dyspnoea> Borg 7

Intervention Type OTHER

Interventions

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measure dyspnoea> Borg 7

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients over 18 years old
* ventilation for whatever reason
* in the ST mode
* not in life support
* at more than 1 month after the last episode of respiratory decompensation

Exclusion Criteria

* guardianship
* inability to understand instructions and provide consent
* uncontrolled psychiatric disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Dijon Bourgogne

Dijon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Clément FOIGNOT

Role: CONTACT

03.80.29.37.72 ext. 33

Facility Contacts

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Clément FOIGNOT

Role: primary

03.80.29.37.72 ext. 33

Other Identifiers

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FOIGNOT 2015

Identifier Type: -

Identifier Source: org_study_id

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