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

Phase 3

Recruiting

Conditions: Patients in ICU with risks of Acute Respiratory Distress Syndrome

Registration Number: 2024-517670-15-00

Lead Sponsor: CHU Gabriel-Montpied

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.

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 80

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

Medical history of liver disease attributed to previous exposure to a halogenated agent (including sevoflurane)

Suspected or proven intracranial hypertension

Enrollment in another interventional trial with direct impact on oxygenation

Patient under judicial protection, guardianship or supervision

Patient under psychiatric care as defined by art. L1121-6 of the Public Health Code

Known pregnancy

Study & Design

Study Type: INTERVENTIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
longitudinal evolution in the PaO2/FiO2 ratio		longitudinal evolution in the PaO2/FiO2 ratio

Secondary Outcome Measures

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

Trial Locations

Locations (1): University Hospital Of Clermont-Ferrand
🇫🇷
Clermont-Ferrand, France
University Hospital Of Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
Matthieu JABAUDON
Site contact
+33473750501
mjabaudon@chu-clermontferrand.fr