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:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT06311604
Eligibility Criteria:
Inclusion Criteria:
* Patient \> 18 years old
* Hospitalized in surgical intensive care (CPR and RNC) for severe head trauma
* On intravenous hypnotic therapy for at least 24 hours with at least 2 lines of IV hypnotics and requiring continued sedation for at least 24 hours, with a RASS of between -3 and -5
* Initial ICP \< 15 mmHg on introduction of isoflurane
* Functional intracranial pressure sensor
* Transcranial Doppler measurements performed within 24 hours
* Written informed consent from a legal representative/relative/trusted person. In the absence of a legal representative, the patient may be included under the emergency procedure.
Exclusion Criteria:
* Patients who have had a decompressive craniectomy
* Patients with a personal or family history of malignant hyperthermia
* Patients with a history of long QT syndrome
* Patients taking MAOI-type antidepressants (iproniazid (MARSILID) and moclobemide (MOCLAMIDE))
* Patients with known hypersensitivity to isoflurane or other volatile halogenated anaesthetic agents
* Patients who have experienced liver damage, jaundice, unexplained fever, or eosinophilia after administration of a halogenated anaesthetic.
* Patients expected to die within the next 24 hours
* Subject in a period of exclusion from another clinical trial,
* Technical unavailability of the inhaler
* Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, women in childbirth, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure).
* No European social security
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06311604
Study Brief:
Protocol Section:
NCT06311604