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

PHASE3RecruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

August 6, 2020

Primary Completion Date

August 31, 2025

Study Completion Date

August 31, 2026

Conditions
Prevention of Delirium
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.

Trial Locations (12)

18000

RECRUITING

CH Bourges, Bourges

29200

RECRUITING

CHU de Brest, Brest

29672

RECRUITING

CH Morlaix, Morlaix

34295

SUSPENDED

CHU Montpellier, Montpellier

35033

RECRUITING

CHU Rennes, Rennes

37044

NOT_YET_RECRUITING

CHU Tours - Réanimation Chirurgicale, Tours

RECRUITING

CHU Tours, Tours

56322

RECRUITING

GHBS Lorient, Lorient

72039

RECRUITING

CH Le Mans, Le Mans

77000

RECRUITING

CH Melun, Melun

86021

RECRUITING

CHU Poitiers, Poitiers

91106

RECRUITING

CH Corbeil Essonnes, Corbeil-Essonnes

All Listed Sponsors
lead

University Hospital, Brest

OTHER

NCT04341350 - Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation | Biotech Hunter | Biotech Hunter