Status:
RECRUITING
Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation
Lead Sponsor:
University Hospital, Brest
Conditions:
Prevention of Delirium
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of the study is to determine the impact on the frequency of occurrence of delirium of an early inhaled sedation strategy (from induction in rapid sequence if intubation in intensive care...
Detailed Description
Sedation-analgesia is used in most patients treated with mechanical ventilation (MV). The usual benzodiazepine and morphine sedation reduces pain and anxiety and allows tolerance of invasive procedure...
Eligibility Criteria
Inclusion
- Patient aged 18 and over
- Patient requiring mechanical ventilation for at least 24 hours
- The patient requires continuous and immediate sedation for more comfort, safety and to facilitate the administration of survival measures.
- Consent obtained from patient or relative
Exclusion
- Patient hospitalized for the following reasons for admission:
- Cardiac arrest
- State of refractory epilepticus
- Head trauma
- Stroke
- Hearing, visual or aphasia disorders before inclusion making it impossible to take the CAM-ICU
- 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 acute respiratory distress syndrome (ARDS) (Berlin criteria: PaO2 / FiO2 \<100 after ventilatory optimisation))
- PaCO2 at inclusion\> 50 mmHg after ventilatory optimisation
- Patient for whom a procedure of "limitation of active therapies" is envisaged at inclusion
- Patient under guardianship or curatorship
- Minor patient
- Pregnant or breastfeeding woman
- Patient not affiliated to the social security scheme
Key Trial Info
Start Date :
August 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04341350
Start Date
August 6 2020
End Date
August 1 2026
Last Update
April 4 2025
Active Locations (12)
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1
CH Bourges
Bourges, France, 18000
2
CHU de Brest
Brest, France, 29200
3
CH Corbeil Essonnes
Corbeil-Essonnes, France, 91106
4
CH Le Mans
Le Mans, France, 72039