NCT04341350 Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation
| NCT ID | NCT04341350 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Brest |
| Condition | Prevention of Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2020-08-06 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 250 participants in total. It began in 2020-08-06 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, or from admission if intubated in pre -hospital) by Isoflurane using an ANACONDA ™ type system, compared to a conventional intravenous sedation strategy.
Eligibility Criteria
Inclusion Criteria: * 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 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 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
Contact & Investigator
Pierre Bailly, MD
PRINCIPAL INVESTIGATOR
CHRU BREST
Frequently Asked Questions
Who can join the NCT04341350 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Prevention of Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04341350 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 250 participants.
Is NCT04341350 currently recruiting?
Yes, NCT04341350 is actively recruiting participants. Contact the research team at pierre.bailly@chu-brest.fr for enrollment information.
Where is the NCT04341350 trial being conducted?
This trial is being conducted at Bourges, France, Brest, France, Corbeil-Essonnes, France, Le Mans, France and 8 additional locations.
Who is sponsoring the NCT04341350 clinical trial?
NCT04341350 is sponsored by University Hospital, Brest. The principal investigator is Pierre Bailly, MD at CHRU BREST. The trial plans to enroll 250 participants.