Informations générales (source: ClinicalTrials.gov)

NCT04341350 En recrutement
Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation : INASED Study (INASED)
Interventional
  • Délire avec confusion
Phase 3
University Hospital, Brest (Voir sur ClinicalTrials)
août 2020
août 2026
05 avril 2025
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.
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Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU de Brest - 29200 - Brest - France Pierre Bailly, MD En recrutement Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CH Bourges - 18000 - Bourges - France Anna BOURREAU, Dr En recrutement Contact (sur clinicalTrials)
CH Corbeil Essonnes - 91106 - Corbeil-Essonnes - France Billiou Cecilia, MD En recrutement Contact (sur clinicalTrials)
CH Le Mans - 72039 - Le Mans - France Christophe GUITTON, Dr En recrutement Contact (sur clinicalTrials)
CH Melun - 77000 - Melun - France Sandie MAZERAND, MD En recrutement Contact (sur clinicalTrials)
CH Morlaix - 29672 - Morlaix - France Pierre-Yves EGRETEAU, Dr En recrutement Contact (sur clinicalTrials)
CHU Montpellier - 34295 - Montpellier - France Suspendu Contact (sur clinicalTrials)
CHU Poitiers - 86021 - Poitiers - France Arnaud THILLE, Pr En recrutement Contact (sur clinicalTrials)
CHU Rennes - 35033 - Rennes - France Florian REIZINE, Dr En recrutement Contact (sur clinicalTrials)
CHU Tours - 37044 - Tours - France Stephan EHRMANN, Pr En recrutement Contact (sur clinicalTrials)
CHU Tours - Réanimation Chirurgicale - 37044 - Tours - France Mathilde BARBAZ Recrutement non commencé Contact (sur clinicalTrials)
GHBS Lorient - 56322 - Lorient - France Guillaume GRILLET, Dr En recrutement Contact (sur clinicalTrials)

Critères

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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



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