Status:
COMPLETED
Restrictive Use of Restraints and Delirium Duration in ICU
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Restraint, Physical
Mechanical Ventilation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The R2D2-ICU study will be a prospective, parallel-group, open label, multicenter (6 centers) randomized controlled trial. All consecutive eligible patients will be included. Patients will be randomly...
Detailed Description
Physical restraint (PR) is defined by the HAS (Haute Autorité de Santé française) as the use of any intervention that prevent or limit movements capability, to protect a person from an inappropriate o...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2025
Estimated Enrollment :
423 Patients enrolled
Trial Details
Trial ID
NCT04273360
Start Date
January 25 2021
End Date
September 8 2025
Last Update
November 24 2025
Active Locations (1)
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1
Hôpital Bichat-Claude Bernard
Paris, France, 75018