Comparison of an inhaled sedation strategy to an intravenous sedation strategy in ICU patients treated with invasive mechanical ventilatio

Phase 1

• Conditions: Prevention of delirium; MedDRA version: 21.0Level: LLTClassification code 10072852Term: Post-injection delirium/sedation syndromeSystem Organ Class: 100000004852; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2019-004537-16-FR
• Lead Sponsor: CHRU de Brest

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-10
• Last Update Posted: 15 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Patient aged 18 and over
• Patient requiring mechanical ventilation for at least 24 hours
• Consent obtained from the patient or a relative
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient hospitalized for the following reasons for admission:
-Cardiac arrest
- State of refractory epilepticus
- Head trauma
- Stroke
• Hearing, visual or aphasia disorders before inclusion
• Sedation started more than 24 hours ago
• Impairment of cognitive functions and / or dementia
• Contraindication to halogenated gases (personal or family history of malignant hyperthermia, acute or chronic neuromuscular disease, hepatocellular insufficiency with PT <30%)
• Severe SDRA (Berlin criteria)
• PaCO2 at inclusion> 50 mmHg
• Pregnancy in progress or lactating woman
• Patient for whom a procedure of limitation of active therapies is envisaged at inclusion
• Patient under guardianship or curatorship

Study & Design

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