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

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

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.

Study Overview

• Status: Unknown
• Conditions: Prevalence of and Factors Associated With Reventilation Syndrome (DS)
• Intervention / Treatment: Other: measure dyspnoea> Borg 7

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • Recruiting
    • CHU Dijon Bourgogne
    • Contact: Clément FOIGNOT; Phone Number: 33 03.80.29.37.72; Email: clement.foignot@chu-dijon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

population of patients with ventilation whatever the reason, in a stable state, and followed by the medical devices department of Dijon CHU

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DS	Other: measure dyspnoea> Borg 7
no DS	Other: measure dyspnoea> Borg 7

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (ESTIMATE): August 1, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): August 2, 2016
• Last Update Submitted That Met QC Criteria: August 1, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: FOIGNOT 2015