Inhaled Sevoflurane for ARDS Prevention (IPA)

University Hospital, Clermont-Ferrand

Status and phase: Enrolling; Phase 3

Conditions: Acute Respiratory Distress Syndrome

Treatments: Drug: Intravenous sedation (current practice); Drug: Inhaled sedation with sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT05849779

IPA trial (AOI 2019 JABAUDON)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years
2. Admitted to participating ICUs with at least one known risk factor for ARDS and a LIPS 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 criteria

• Patient under judicial protection, guardianship or supervision, as defined by art L1121-8 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 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)
• Absolute contra-indications to the intravenous sedation 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Inhaled sedation with sevoflurane

Experimental group

Description:

Sevoflurane as vaporized via the Anesthesia Conserving Device (Sedaconda-ACD-S, Sedana Medical, Danderyd, Sweden).

Treatment:

Drug: Inhaled sedation with sevoflurane

Intravenous sedation

Active Comparator group

Description:

The investigators will not mandate the sedative type, but rather encourage the use of sedatives that are already routinely used in participating ICUs (typically a benzodiazepine, propofol, or dexmedetomidine, i.e. drugs approved for sedation).

Treatment:

Drug: Intravenous sedation (current practice)