ISOFLURANE for Delirium

Inclusion criteria

• {"criterion_text":"- Patient aged 18 and over\n- Patient requires mechanical ventilation for at least 24 hours\n- Patient requires immediate continuous sedation for comfort, safety and to facilitate the administration of life-sustaining measures.\n- Consent obtained from patient or relative"}

Exclusion criteria

• {"criterion_text":"- Patient admitted for the following reasons : - Cardiac arrest - Refractory status epilepticus - Moderate to severe head trauma - Cerebrovascular accident\n- Minors\n- Pregnant or breast-feeding women\n- Patient not affiliated to the social security system\n- Auditory or visual impairment, or aphasia prior to inclusion, making CAM-ICU impossible to perform\n- Sedation for more than 24 hours\n- Impaired cognitive function and/or dementia\n- Contraindication to halogenated gas (personal or family history of malignant hyperthermia, acute or chronic neuromuscular disease, hepatocellular insufficiency with TP<30%)\n- Severe ARDS (Berlin criteria: PaO2/FiO2<100 after ventilatory optimization)\n- PaCO2 at inclusion > 50 mmHg with pH<7.2 after ventilatory optimization\n- Patient for whom a \"limitation of active therapies\" procedure is envisaged on inclusion\n- Patient under guardianship or curatorship"}

Primary endpoints

• {"endpoint_text":"- Occurrence (yes/no) of delirium in intensive care unit","definition_or_measurement_approach":"Occurrence recorded as yes/no; CAM-ICU scale is used in the study (CAM-ICU scale listed as an assessment performed twice daily)."}

Secondary endpoints

• {"endpoint_text":"- ICU mortality, D28 mortality","definition_or_measurement_approach":"Mortality in ICU and mortality at day 28"}
• {"endpoint_text":"- Length of stay in intensive care","definition_or_measurement_approach":"Duration of ICU hospitalization"}
• {"endpoint_text":"- Number of days living without mechanical ventilation in intensive care at D28","definition_or_measurement_approach":"Number of days alive and free from mechanical ventilation up to day 28"}
• {"endpoint_text":"- CAM-ICU scale (2 times/day)","definition_or_measurement_approach":"Assessment using the CAM-ICU scale performed twice daily"}
• {"endpoint_text":"- The quality of sedation is defined by: compliance (yes/no) with the sedation target (sedation score set as the target when prescribing)","definition_or_measurement_approach":"Compliance (yes/no) with predefined sedation target score at prescription"}
• {"endpoint_text":"- Need for additional medication to alleviate agitation (yes/no, and if yes neuroleptic, benzodiazepine, dexmedetomidine)","definition_or_measurement_approach":"Recorded as yes/no and, if yes, type of additional medication (neuroleptic, benzodiazepine, dexmedetomidine)"}
• {"endpoint_text":"- Need for additional physical restraint to alleviate a state of agitation (yes/no)","definition_or_measurement_approach":"Recorded as yes/no for requirement of additional physical restraint"}
• {"endpoint_text":"- Number of accidental removals by the patient of intubation tubes, vascular access tubes, nasogastric tubes and urinary catheters, based on the number of days in intensive care.","definition_or_measurement_approach":"Count of accidental removals normalized per number of days in ICU"}
• {"endpoint_text":"- Number of self- or hetero-aggressive acts per number of days in intensive care","definition_or_measurement_approach":"Count of self- or hetero-aggressive acts normalized per number of days in ICU"}
• {"endpoint_text":"- Average hospital costs per patient","definition_or_measurement_approach":"Mean hospital cost per patient"}
• {"endpoint_text":"- Daily and cumulative dose of sedative","definition_or_measurement_approach":"Recording of daily and cumulative sedative doses"}
• {"endpoint_text":"- Cognitive consequences will be assessed. Calculation of CDR and IQCODE scores. Cognitive, psychological and quality of life assessment at 3 and 12 months.","definition_or_measurement_approach":"Cognitive consequences assessed via calculation of CDR and IQCODE scores and additional cognitive, psychological and QoL assessments at 3 and 12 months"}

France

Earliest CTIS Part Ii Submission Date

07-08-2024

Latest Decision Or Authorization Date

02-06-2025

Processing Time Days

299

Number Of Sites

11

Number Of Participants

250

Primary sponsor

Full Name

Centre Hospitalier Regional Et Universitaire De Brest

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France