Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT04341350

Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation

Led by University Hospital, Brest · Updated on 2025-04-04

250

Participants Needed

12

Research Sites

312 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged 18 and over
  • Patient requiring mechanical ventilation for at least 24 hours
  • Patient requires continuous and immediate sedation for comfort, safety, and survival measures
  • Consent obtained from patient or relative
Not Eligible

You will not qualify if you...

  • Hospitalized due to cardiac arrest
  • State of refractory epilepticus
  • Head trauma
  • Stroke
  • Hearing, visual, or aphasia disorders preventing CAM-ICU assessment
  • Sedation started more than 24 hours ago
  • Cognitive impairment or dementia
  • Contraindication to halogenated gases (malignant hyperthermia history, neuromuscular disease, severe liver insufficiency)
  • Severe acute respiratory distress syndrome (PaO2/FiO2 <100 after ventilation optimization)
  • PaCO2 > 50 mmHg after ventilation optimization
  • Planned limitation of active therapies
  • Under guardianship or curatorship
  • Minor patient
  • Pregnant or breastfeeding woman
  • Not affiliated with social security scheme

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 12 locations

1

CH Bourges

Bourges, France, 18000

Actively Recruiting

2

CHU de Brest

Brest, France, 29200

Actively Recruiting

3

CH Corbeil Essonnes

Corbeil-Essonnes, France, 91106

Actively Recruiting

4

CH Le Mans

Le Mans, France, 72039

Actively Recruiting

5

GHBS Lorient

Lorient, France, 56322

Actively Recruiting

6

CH Melun

Melun, France, 77000

Actively Recruiting

7

CHU Montpellier

Montpellier, France, 34295

Suspended

8

CH Morlaix

Morlaix, France, 29672

Actively Recruiting

9

CHU Poitiers

Poitiers, France, 86021

Actively Recruiting

10

CHU Rennes

Rennes, France, 35033

Actively Recruiting

11

CHU Tours - Réanimation Chirurgicale

Tours, France, 37044

Not Yet Recruiting

12

CHU Tours

Tours, France, 37044

Actively Recruiting

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Research Team

P

Pierre Bailly, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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