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

• Conditions: Prevalence of and Factors Associated With Reventilation Syndrome (DS)
• Interventions: Other: measure dyspnoea> Borg 7

• Registration Number: NCT02851446
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

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

Not available

Study Timeline

• Study Start: 2015-10
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-08-01
• Last Update Submitted: 2016-08-01
• Last Update Posted: 2016-08-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
no DS	measure dyspnoea> Borg 7	-
DS	measure dyspnoea> Borg 7	-

Primary Outcome Measures

Name	Time	Method
presence of diagnostic criteria for reventilation Syndrome (dyspnoea > Borg 7)	at withdrawal of the machine, disabling for everyday activities for at least 30 minutes after stopping the ventilation

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France