Randomized Clinical Trial of Inhaled Sedation with Sevoflurane in Critically Ill Patients at Risk of Developing the Acute Respiratory Distress Syndrome

CHU Gabriel-Montpied1 site in 1 country80 target enrollmentOctober 10, 2024

DrugsUSL-261 NIMBEX 5 mg/ml, solution injectable/pour perfusion HYPNOVEL 1 mg/ml, solution injectable ICI-35868 Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion DIPRIVAN 20 mg/ml, émulsion injectable en seringue pré-remplie SEVOFLURANE BAXTER 1 ml/ml, liquide pour inhalation par vapeur 2,6-Bis(PROPAN-2-YL)PHENOL DISOPROFOL

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: CHU Gabriel-Montpied
Enrollment: 80
Locations: 1
Primary Endpoint: longitudinal evolution in the PaO2/FiO2 ratio
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To assess the efficacy of inhaled sevoflurane, compared to current intravenous sedation practice, for improving PaO2/FiO2 in ICU patients at high risk for ARDS.

Detailed Description

MAIN OBJECTIVE To assess the efficacy of inhaled sevoflurane, compared to current intravenous sedation practice, for improving PaO2/FiO2 in ICU patients at high risk for ARDS. HYPOTHESIS The investigators hypothesized that a strategy of inhaled sedation with sevoflurane could be more effective than current intravenous sedation practice at improving pulmonary function during the early days of ICU admission, in patients at risk of ARDS.

Registry

euclinicaltrials.eu

Start Date

October 10, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional

Investigators

Sponsor

CHU Gabriel-Montpied

Responsible Party

Principal Investigator

Lise Laclautre

Scientific

CHU Gabriel-Montpied

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years
•Admitted to participating ICUs with at least one known risk factor for ARDS and a LIPS equals to, or greater than 4
•Patient under invasive mechanical ventilation
•With expected duration of sedation superior or equal to 4 hours
•Affiliation to the French Sécurité Sociale

Exclusion Criteria

•Patient under a tutelage measure
•Presence of ARDS prior to randomization
•Endotracheal ventilation for greater than 24 hours prior to randomization
•Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep-disordered breathing
•Tidal volume of 6 mL/kg predicted body weight (PBW) below 200 mL (i.e. height inferior to 134cm for a man and 139cm for a woman)
•Moribund patient, i.e. not expected to survive 24 hours despite intensive care
•Previous hypersensitivity or anaphylactic reaction to sevoflurane or to the intravenous sedation agent routinely used in the participating ICU (such as midazolam, propofol, or dexmedetomidine)
•Contra-indications to the intravenous sedative agent routinely used in the participating ICU (such as midazolam, propofol, or dexmedetomidine
•Medical history of malignant hyperthermia
•Long QT syndrome at risk of arrhythmic events

Outcomes

Primary Outcomes

longitudinal evolution in the PaO2/FiO2 ratio

Secondary Outcomes

Progression to ARDS will be assessed according to the Berlin criteria, including chest radiographs
Rate of pneumonia
Ventilator-free days
Organ failure-free days
Mortality
Length of ICU-stay
Physiological measures
ICU-acquired delirium
Biomarker measurements