Status:
SUSPENDED
Inhalational (Sevoflurane) Versus Intravenous (Propofol) Sedation in Adults With a Moderate Form of ARDS
Lead Sponsor:
Negovsky Reanimatology Research Institute
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The American European Consensus Conference (AECC) 1994 defined acute respiratory distress syndrome (ARDS) as an acute inflammatory syndrome manifesting as diffuse pulmonary edema and respiratory failu...
Eligibility Criteria
Inclusion
- Age \> 18
- Endotracheal intubation or tracheostomy
- Timing: Acute onset of new or worsening of chronic respiratory symptoms within 72 hours before the randomization
- Chest imaging: Bilateral opacities-not fully explained by effusions, lobar/lung collapse, or nodules
- Origin of edema: Respiratory failure not fully explained by cardiac failure or fluid overload
- Oxygenation: 100 mm Hg \< PaO2/FiO2 ≤ 200 mm Hg with PEEP ≥ 5 cm H2O
Exclusion
- History or family history of malignant hyperthermia
- History of propofol infusion syndrome
- Documented or suspected increased intracranial pressure
- Chronic restrictive pulmonary disease
- Chronic obstructive pulmonary disease
- Neuromuscular disease
- Chest wall disorder
- Pulmonary vascular disease
- NYHA class ≥ 3
- Severe pulmonary hypertension (mean pulmonary artery pressure \> 40 mmHg)
- Documented ongoing COVID-19 infection
- Ongoing immunosuppressive therapy
- Previous randomization in this trial
- Post randomization exclusion criterion: Documented ongoing COVID-19 infection during the first 48 hours after the randomization
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 25 2026
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT05259631
Start Date
March 14 2022
End Date
February 25 2026
Last Update
February 1 2023
Active Locations (1)
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1
Demikhov Municipal Clinical Hospital 68
Moscow, Russia