Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT04023305
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* 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:
* Lack of informed consent
* 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)
* PaO2/FiO2 (if available) \> 200 mmHg after meeting inclusion criteria and before start of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04023305
Study Brief:
Protocol Section:
NCT04023305