Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT04273360
Eligibility Criteria:
Inclusion criteria :
* Patients fulfilling all the following criteria will be eligible:
* Adults ≥ 18 years
* MV expected for at least ≥ 48 hours
* Invasive MV in the ICU for a duration inferior to 6 hours
* eligible to prescription for physical contention
Exclusion criteria :
Patients meeting one of the following criteria will not be considered for inclusion:
* Documented delirium prior to ICU admission according to the CAM-ICU
* History of dementia (Mini mental test \< 24)
* Alcoholic withdrawal syndrome expected
* Admission for any neurological disease including post-cardiopulmonary resuscitation (including cardiac arrest, stroke, traumatic brain injury, meningoencephalitis, and status epilepticus)
* Serious auditory or visual disorders
* Unable to understand French
* Pregnant or lactating women
* SAPS II \> 65 points at screening
* Do-not-resuscitate orders (advance directives)
* No affiliation to a social security regime (beneficiary or assignee)
* Patient or person of confidence (if present at the time of inclusion) opposing the patient's participation in research
* Patient already involved in another interventional clinical research whose main objective is related to delirium
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04273360
Study Brief:
Protocol Section:
NCT04273360