NCT02166853

Brief Summary

Numerous trials support the efficacy and safety of volatile anesthetic agents, namely inhalation of sevoflurane through dedicated devices, for the sedation of ICU patients. Several preclinical studies have shown that sevoflurane inhalation improves gas exchange and decreases pulmonary and systemic inflammation in experimental models of acute respiratory distress syndrome (ARDS). The purpose of our prospective monocentric, randomized, controlled trial is to evaluate the effects of an early 48-hour sevoflurane inhalation on gas exchange and inflammation in patients with ARDS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

June 16, 2014

Last Update Submit

April 16, 2026

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute respiratory distress syndrome (ARDS)SevofluraneMechanical ventilationIntensive Care Unit (ICU)Prospective studyLung injuryGas exchangeInflammationReceptor for advanced glycation end-produts (RAGE)sRAGE

Outcome Measures

Primary Outcomes (1)

  • PaO2/FiO2 ratio

    at 48 hours

Secondary Outcomes (12)

  • - Plasma and alveolar levels of proinflammatory cytokines : tumor necrosis factor alpha (TNFα, interleukin (IL)-1β, IL-6, IL-8

    at 48 hours

  • Plasma and alveolar levels of sRAGE

    at 48 hours

  • PaO2/FiO2 ratio

    at day 1, day 3, day 5

  • Lowest PaO2/FiO2 during the first 5 days of the study

    at 5 days

  • Mean PaO2/FiO2 ratio during the first 5 days of the study

    at 5 days

  • +7 more secondary outcomes

Study Arms (2)

conventional group

EXPERIMENTAL

a "conventional group", in which intravenous sedation with midazolam will be administered

Drug: midazolam

sevoflurane group

EXPERIMENTAL

a "sevoflurane group", in which patients will inhale sevoflurane during a 48 hour-period, through dedicated devices

Drug: sevoflurane

Interventions

sevofluraneDRUG

Sedation with inhaled sevoflurane

sevoflurane group
midazolamDRUG

Sedation with intravenous midazolam

conventional group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with criteria for moderate to severe ARDS since less than 24 hours (
  • Informed consent

You may not qualify if:

  • Suspected or proven intracranial hypertension
  • Midazolam, sevoflurane or cisatracurium allergy
  • Medical history of malignant hyperthermia
  • Severe liver failure
  • Chemotherapy treatment in the last month
  • Severe neutropenia (\< 0.5 G/l)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • Jabaudon M, Boucher P, Imhoff E, Chabanne R, Faure JS, Roszyk L, Thibault S, Blondonnet R, Clairefond G, Guerin R, Perbet S, Cayot S, Godet T, Pereira B, Sapin V, Bazin JE, Futier E, Constantin JM. Sevoflurane for Sedation in Acute Respiratory Distress Syndrome. A Randomized Controlled Pilot Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):792-800. doi: 10.1164/rccm.201604-0686OC.

    PMID: 27611637RESULT

MeSH Terms

Conditions

Respiratory Distress SyndromeLung InjuryInflammation

Interventions

SevofluraneMidazolam

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersThoracic InjuriesWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Matthieu JABAUDON

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2014

First Posted

June 18, 2014

Study Start

April 1, 2014

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

FR(1)