Inhaled Sevoflurane for ARDS Prevention

Last updated: July 26, 2024
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Active - Recruiting

Phase

3

Condition

Lung Injury

Respiratory Failure

Acute Respiratory Distress Syndrome (Ards)

Treatment

Intravenous sedation (current practice)

Inhaled sedation with sevoflurane

Clinical Study ID

NCT05849779
IPA trial (AOI 2019 JABAUDON)
  • Ages > 18
  • All Genders

Study Summary

This study focuses on patients who are at risk of developing a serious, life-threatening respiratory disease called Acute Respiratory Distress Syndrome (ARDS), which severely disrupts the function of their lungs.

Preclinical studies have shown that the use of a volatile anesthetic agent such as Sevoflurane could be beneficial in the treatment and prevention of this respiratory condition. By improving gas exchange and attenuating pulmonary inflammation in particular, this agent would make it possible to prevent deterioration or to restore pulmonary function more rapidly.

Half of the patients will receive inhaled sedation with sevoflurane and the other half will receive intravenous sedation already routinely used in participating ICUs (typically propofol, dexmedetomidine or a benzodiazepine, i.e. drugs approved for sedation).

The aim of this study is to assess whether the use of Sevoflurane could be beneficial in the prevention of ARDS.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years

  2. Admitted to participating ICUs with at least one known risk factor for ARDS and aLIPS equals to, or greater than, 4 (Appendix D)105

  3. Patient under invasive mechanical ventilation

  4. With expected duration of sedation superior or equal to 4 hours

  5. Affiliation to the French Sécurité Sociale

Exclusion

Exclusion Criteria:

  • Patient under judicial protection, guardianship or supervision, as defined by artL1121-8 of the Public Health Code

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

  • Patient deprived of their freedom by judiciary or administrative order

  • Known pregnancy

  • 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 forCPAP/BIPAP used solely for sleep-disordered breathing

  • Tidal volume of 6 mL/kg predicted body weight (PBW) below 200 mL (i.e. heightinferior 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 theintravenous sedation agent routinely used in the participating ICU (such asmidazolam, propofol, or dexmedetomidine)

  • Absolute contra-indications to the intravenous sedation agent routinely used in theparticipating 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 halogenatedagent (including sevoflurane)

  • Suspected or proven intracranial hypertension

  • Enrollment in another interventional trial with direct impact on oxygenation

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Intravenous sedation (current practice)
Phase: 3
Study Start date:
July 24, 2023
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • CHU Clermont-Ferrand

    Clermont-ferrand, Not Required For This Country 63000
    France

    Active - Recruiting

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