Prevalence of and Factors Associated With Reventilation Syndrome (DS) Clinical Trial
— DEVENTILATIONOfficial title:
Prevalence and Risk Factors of Dreentilation Syndrome in a Population of Patients Under Ventilation for Whatever Reason
| NCT number | NCT02851446 |
| Other study ID # | FOIGNOT 2015 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | July 28, 2016 |
| Last updated | August 1, 2016 |
| Start date | October 2015 |
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.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Dijon Bourgogne | Dijon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire Dijon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |