protocolSection identificationModule nctId: NCT06311604, orgStudyIdInfo id: 38RC22.0272, briefTitle: Evaluation of the Safety of Inhaled Sedation With Isoflurane in Head Trauma Patients, acronym: IsoSAFE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University Hospital, Grenoble, class: OTHER, descriptionModule briefSummary: Intensive care management of patient with severe traumatic brain injury (TBI) includes deep and prolonged sedation with intravenous hypnotics (propofol, midazolam, ketamine) in combination with opioids to prevent and/or treat episodes of intracranial hypertension. However, some patients may develop tachyphylaxis with a gradual increase of administered intravenous hypnotics and opioids to maintain the same level of sedation. This situation leads to a failure in controlling intracranial pressure (ICP) and/or to the risk of adverse effects due to high-dose sedatives: haemodynamic instability, prolonged mechanical ventilation, neuromyopathy, delirium, withdrawal syndrome.Halogenated agents (Isoflurane, Sevoflurane) are a class of hypnotics routinely used in the operating room. However, doses used in surgical patients (\> 1 Minimal Alveolar Concentration, MAC) are not suitable in neuro-intensive care unit (ICU) patients at risk of intracranial hypertension because of the cerebral vasodilator effects of halogenated agents at this dosage, hence the risk of high ICP and compromised cerebral perfusion pressure.The use of halogenated agents has been recently possible in the ICU through dedicated medical devices (Sedaconda ACD, Mirus). Recommended dosage are lower in the ICU, i.e. 0.3-0.7 MAC, because of their association with intravenous hypnotics and the absence of surgical stimuli. Several clinical studies in general ICUs showed improved sedation quality, reduced duration of mechanical ventilation, faster arousal and shorter extubation time, and lower costs in halogenated group compared with control group receiving midazolam or propofol. At low doses, the effects on ICP and intracerebral haemodynamics of halogenated agents are minor according to the available literature. In addition, beneficial effects were found on cerebral ischaemic volume in animal models treated with halogenated agents. However, there is a need to explore the benefit-risk ratio of the use of halogenated agents in the severe TBI population.The investigator hypothesise that 0.7 MAC Isoflurane can be administered in this population without deleterious effect on ICP., conditionsModule conditions: Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, open-label, single-centre, interventional dose escalation study, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Isoflurane, outcomesModule primaryOutcomes measure: To assess the safety of sedation with 0.7 MAC of inhaled isoflurane in cranial trauma patients in terms of intracranial pressure., secondaryOutcomes measure: To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma., secondaryOutcomes measure: To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma., secondaryOutcomes measure: To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma., secondaryOutcomes measure: To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma., secondaryOutcomes measure: To assess the extra-neurological effects of inhaled isoflurane sedation in head trauma patients, secondaryOutcomes measure: To assess the extra-neurological effects of inhaled isoflurane sedation in head trauma patients, secondaryOutcomes measure: To assess the extra-neurological effects of inhaled isoflurane sedation in head trauma patients, secondaryOutcomes measure: To assess the savings in intravenous hypnotics associated with isoflurane inhalation sedation in head trauma patients, secondaryOutcomes measure: To assess the feasibility of inhaled sedation with isoflurane in patients with head trauma, secondaryOutcomes measure: To assess the neurological outcome at D28 after inhaled sedation in head trauma patients, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Grenoble, city: Grenoble, state: Choisir Une Région, zip: 38043, country: France, contacts name: barthélémy H Grenoble, MD, role: CONTACT, phone: +33476766879, email: bbertrand4@chu-grenoble.fr, contacts name: Anais ADOLLE, role: CONTACT, phone: +33476766879, email: aadolle@chu-grenoble.fr, geoPoint lat: 45.16667, lon: 5.71667, hasResults: False