Status:
UNKNOWN
Effects of Sevoflurane on Extravascular Lung Water and Pulmonary Vascular Permeability in Patients With ARDS
Lead Sponsor:
Bicetre Hospital
Conditions:
ARDS
ARDS, Human
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
The study will investigate the effects of inhaled sedation with sevoflurane using the AnaConDa device on extravascular lung water index (EVLWi) and the pulmonary vascular permeability index (PVPI) in ...
Detailed Description
Background: Inhaled sedation with volatile anesthetic agents has been proposed as an efficient and safe alternative to usual intravenous sedation such as propofol or midazolam in the intensive care u...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Presence of acute respiratory distress syndrome for ≤24 hours of all of the following conditions, within one week of a clinical insult or new or worsening respiratory symptoms:
- PaO2/FiO2 \<150 mmHg with positive end-expiratory pressure (PEEP) ≥8 cmH2O (or, if arterial blood gas not available, SpO2/FiO2 that is equivalent to a
- PaO2/FiO2 \<150 mmHg with PEEP ≥8 cmH2O and a confirmatory SpO2/FiO2 between 1-6 hours after the initial SpO2/FiO2 determination)
- Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules
- 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
- PaO2/FiO2 \<200 mmHg after meeting inclusion criteria and before randomization
Exclusion
- Absence of affiliation to the French Sociale security
- Patient under a tutelage measure or placed under judicial protection
- Known pregnancy
- Currently receiving ECMO therapy
- Chronic liver disease defined as a Child-Pugh score of 12-15
- Severe hepatic failure
- Expected duration of mechanical ventilation \<48 hours
- 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
- Medical history of liver disease attributed to previous exposure to a halogenated agent
- Known hypersensitivity to propofol or any of its components
- Suspected or proven intracranial hypertension
- Tidal volume of 6 mL/kg predicted body weight (PBW) below 200 mL (as recommended by the manufacturer for the use of the AnaConDa-S (Sedana Medical, Danderyd, Sweden)
- Enrollment in another interventional ARDS trial with direct impact on sedation and mechanical ventilation
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04530188
Start Date
November 1 2020
End Date
November 1 2022
Last Update
August 28 2020
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