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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT06620393
Eligibility Criteria:
Inclusion Criteria:
1. Adults (≥18 years) admitted to ICU with a critically ill moderate or severe TBI patients. Severity of TBI will be determined with the first Glasgow Coma Score (GCS). TBI patients with polytrauma and patients undergoing neurosurgical interventions will be eligible.
2. Undergoing mechanically ventilation (of any duration) at the time of assessment.
3. Anticipated ICU stay of 48 hours or more.
Exclusion Criteria:
1. Patients at very high risk of short-term mortality (e.g., GCS of 3 without sedation, or unreactive pupils, or declared brain-dead when assessed for eligibility and patients in whom there is a lack of commitment to ongoing life support
2. Patients unable to communicate in English or French (interfering with posttraumatic amnesia assessments)
3. Patients with cognitive impairment as per family evaluation
4. Pregnant or breastfeeding
5. Patients currently receiving DEX or clonidine
6. Allergy, bradycardia or hypotension precluding use of dexmedetomidine as per treating physician
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06620393
Study Brief:
Protocol Section:
NCT06620393