Comparing inhaled and intravenous sedation for ICU patients on mechanical ventilation
Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation : INASED Study
This study is testing if using inhaled sedation instead of intravenous sedation can help ICU patients on mechanical ventilation feel more comfortable and reduce the chances of developing delirium.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 12 sites (Bourges and 11 other locations) |
| Trial ID | NCT04341350 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of an inhaled sedation strategy using Isoflurane compared to traditional intravenous sedation in patients receiving invasive mechanical ventilation. The focus is on reducing the incidence of delirium, a common complication that can worsen patient outcomes. Participants will be monitored for sedation effectiveness and overall recovery, with the goal of improving comfort and safety during mechanical ventilation. The study will include patients aged 18 and older who require sedation for at least 24 hours.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over who require mechanical ventilation for at least 24 hours and need continuous sedation.
Not a fit: Patients with severe acute respiratory distress syndrome, cognitive impairments, or contraindications to halogenated gases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of delirium in ICU patients, leading to better recovery outcomes.
How similar studies have performed: Previous studies have shown promising results with inhaled sedation strategies, suggesting potential benefits in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bourges and 11 other locations
- CH Bourges — Bourges, France (Recruiting)
- CHU de Brest — Brest, France (Recruiting)
- CH Corbeil Essonnes — Corbeil-Essonnes, France (Recruiting)
- CH Le Mans — Le Mans, France (Recruiting)
- GHBS Lorient — Lorient, France (Recruiting)
- CH Melun — Melun, France (Recruiting)
- CHU Montpellier — Montpellier, France (Suspended)
- CH Morlaix — Morlaix, France (Recruiting)
- CHU Poitiers — Poitiers, France (Recruiting)
- CHU Rennes — Rennes, France (Recruiting)
- CHU Tours - Réanimation Chirurgicale — Tours, France (Not_yet_recruiting)
- CHU Tours — Tours, France (Recruiting)
Study contacts
- Principal investigator: Pierre Bailly, MD — Chru Brest
- Study coordinator: Pierre Bailly, MD
- Email: pierre.bailly@chu-brest.fr
- Phone: 02 98 34 71 81
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.