Comparison of an inhaled sedation strategy with an intravenous sedation strategy in intensive care patients treated with invasive mechanical ventilation: INASED study

Phase 1

• Conditions: Delirium; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2024-513530-37-00
• Lead Sponsor: Centre Hospitalier Regional Et Universitaire De Brest

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-31
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified