Study Results
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.
COMPLETED
60 participants
OBSERVATIONAL
2013-05-31
2013-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The main objective is to quantify the loss of diaphragm function by measuring the diaphragm force (using the non invasive method by phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion) in a selected population of patients with critical illness neuromyopathy (defined as a MRC score \< 48).
The second end points are to evaluate its incidence, the consequences on the patients outcome (extubation success or failure; ICU stay) and to evaluate the relations between diaphragm function (twitch airway pressure during airway occlusion, maximal inspiratory pressure and diaphragm thickness evaluated by ultrasound) and peripheral limbs force (evaluated by the Medical Research Council - MRC score).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
All these measurements will be made at the time of the spontaneous breathing trial (SBT) during the weaning phase. No modification of the clinical practices of the care should be modified by the study. The twitch airway pressure during airway occlusion will be assessed at the begining of the SBT. The other measurements will be performed 30 mn after the SBT if this one will be well tolerated.
Participants will be followed for the duration of ICU stay.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Critical illness neuromyopthy
Non invasive phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion
Non invasive phrenic nerve stimulation
Non invasive phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Non invasive phrenic nerve stimulation
Non invasive phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ready for weaning from mechanical ventilation
Exclusion Criteria
* impossibility to perform a magnetic stimulation
* cervical spine injury
* bihemispheric or brain stem lesion
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Montpellier
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Samir Jaber, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Anesthesiology & Critical Care, St Eloi University
Montpellier, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
9163
Identifier Type: -
Identifier Source: org_study_id