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RECRUITING
NCT04341350
PHASE3

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

Sponsor: University Hospital, Brest

View on ClinicalTrials.gov

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.

Official title: Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation : INASED Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2020-08-06

Completion Date

2026-08

Last Updated

2025-04-04

Healthy Volunteers

No

Interventions

DRUG

Propofol + analgesic drug

sedation according to a written, standardized Nurse management protocol using at least one sedative drug (propofol) and one analgesic drug. It uses the nurse driven analgesia protocol of each ward involved in the study. It uses a pain assessment score (BPS, VICOMORE, FLACC), local or regional anesthesia, non-opioïd adjuncts (acetaminophen, NSAIDs, nefopam), opioïds (per os opioïds, bolus of sufentanyl followed by continuous infusion if necessary, continuous infusion of remifentanyl

DRUG

Isoflurane + analgesic drug

sedation by inhalation of halogenated gas (Isoflurane) delivered by the Anesthetic-Conserving Device (ACD) system ANACONDA ™ associated with the administration of a analgesic drug. It uses the nurse driven analgesia protocol of each ward involved in the study. It uses a pain assessment score (BPS, VICOMORE, FLACC), local or regional anesthesia, non-opioïd adjuncts (acetaminophen, NSAIDs, nefopam), opioïds (per os opioïds, bolus of sufentanyl followed by continuous infusion if necessary, continuous infusion of remifentanyl.

Locations (12)

CH Bourges

Bourges, France

CHU de Brest

Brest, France

CH Corbeil Essonnes

Corbeil-Essonnes, France

CH Le Mans

Le Mans, France

GHBS Lorient

Lorient, France

CH Melun

Melun, France

CHU Montpellier

Montpellier, France

CH Morlaix

Morlaix, France

CHU Poitiers

Poitiers, France

CHU Rennes

Rennes, France

CHU Tours - Réanimation Chirurgicale

Tours, France

CHU Tours

Tours, France