RecruitingPhase 3NCT04341350

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


Sponsor

University Hospital, Brest

Enrollment

250 participants

Start Date

Aug 6, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Isoflurane + analgesic drug and Propofol + analgesic drug for people with prevention of delirium. The study is currently recruiting participants at 12 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPropofol + 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

DRUGIsoflurane + 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

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NCT04341350