Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
37 participants
INTERVENTIONAL
2020-02-23
2022-01-01
Brief Summary
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Detailed Description
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These patients will receive inhaled sevoflurane as a standard practice of sedation that is routinely used in participating ICUs. After inclusion, the mechanical ventilation protocol must be initiated within two hours (if not already being used). In both groups, deep sedation followed by neuromuscular blockade must be initiated within four hours of inclusion.
Adult patients admitted to the ICU within 12 hours of moderate-severe ARDS onset and under sedation with sevoflurane will be enrolled in the study with inclusion criteria. They will be enrolled, depending on their morphotype (focal or nonfocal), as routinely assessed in participating centers using CT-scan, chest x-ray and/or lung ultrasound.
These patients will receive inhaled sevoflurane as a standard practice of sedation that is routinely used in participating ICUs. After inclusion, the mechanical ventilation protocol must be initiated within two hours (if not already being used). In both groups, deep sedation followed by neuromuscular blockade must be initiated within four hours of inclusion.
Blood sample will be collected at different times after the onset of sevoflurane administration and after its cessation.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
Sevoflurane infusion rate will be adapted from manufacturer's instructions in order to reach a target of expired sevoflurane fraction (FEsevo) of 0.8-1.1.
Mechanical ventilation will be protocolized in both arms, based on recent results of a RCT from our group, in which 90-day survival was improved in patients with nonfocal ARDS when an individualized ventilation strategy was applied, compared to the ARDSNet strategy (PEEP set according to FiO2). We will recommend sites wait at least 12 hours before proning, as in the PROSEVA study.
In both groups, patients will receive cisatracurium besylate for neuromuscular blockade, and deep sedation will be protocolized to Richmond Agitation-Sedation Scale (RASS) of -4 to -5 (Ramsay of 5-6, or Riker of 1-2) before starting, and during, the cisatracurium besylate infusion.
TREATMENT
SINGLE
Study Groups
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Nonfocal ARDS
ARDS patient with nonfocal lung imaging phenotype
Deep sedation by Sevoflurane on the Morphotype of ARDS in ICU patieNts
Pharmacokinetic of inhaled sevoflurane used for sedation
Focal ARDS
ARDS patient with focal lung imaging phenotype
Deep sedation by Sevoflurane on the Morphotype of ARDS in ICU patieNts
Pharmacokinetic of inhaled sevoflurane used for sedation
Interventions
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Deep sedation by Sevoflurane on the Morphotype of ARDS in ICU patieNts
Pharmacokinetic of inhaled sevoflurane used for sedation
Eligibility Criteria
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Inclusion Criteria
* Presence for ≤ 12 hours of all of the following conditions, within one week of a clinical insult or new or worsening respiratory symptoms :
a PaO2/FiO2 \< 200 mmHg with positive end-expiratory pressure (PEEP) ≥ 8 cmH2O (or, if arterial blood gas not available : SpO2/FiO2 ratio that is equivalent to a PaO2/FiO2 \< 200 mmHg with PEEP ≥8 cmH2O, and a confirmatory SpO2/FiO2 ratio between 1-6 hours after the initial SpO2/FiO2 ratio determination) b Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules c Respiratory failure not fully explained by cardiac failure or fluid overload; need objective assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk factor present
Exclusion Criteria
* Continuous sedation with inhaled sevoflurane at enrollment
* Currently receiving ECMO therapy
* Chronic respiratory failure defined as PaCO2 \> 60 mmHg in the outpatient setting
* Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep-disordered breathing
* Body mass index \> 40 kg/m2
* Chronic liver disease defined as a Child-Pugh score of 12-15
* Expected duration of mechanical ventilation \< 48 hours
* Tidal volume of 6 mL/kg predicted body weight (PBW) below 200 mL
* Decision to withhold life-sustaining treatment; except in those patients committed to full support except cardiopulmonary resuscitation
* Moribund patient, i.e. not expected to survive 24 hours despite intensive care
* Burns \> 70% total body surface
* Previous hypersensitivity or anaphylactic reaction to sevoflurane
* Medical history of malignant hyperthermia
* Suspected or proven intracranial hypertension
* Know pregnancy - Pregnancy testing will be systematically performed to rule out pregnancy in female patients of reproductive age
* Enrollment in another interventional ARDS trial with direct impact on sedation and PEEP
* Endotracheal ventilation for greater than 120 hours (5 days)
18 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Raiko Blondonnet, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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Centre Jean Perrin
Clermont-Ferrand, , France
CHU
Clermont-Ferrand, , France
APHP - University hospital of Saint-Louis
Paris, , France
Countries
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Other Identifiers
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2018-003511-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPIDERMAN Study
Identifier Type: -
Identifier Source: org_study_id