Inhaled Sedation in Critically Ill Patients
NCT07000526 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 620
Last updated 2026-05-19
Summary
The proposal of this study is to compare inhaled sedation with isoflurane administered via the Sedaconda ACD-S system with intravenous sedation with propofol. Patients will be randomized 1:1 to receive either inhaled sedation with isoflurane administered via the Sedaconda ACD device (Sedana Medical, Uppsala, Sweden) or intravenous propofol. The primary endpoint is the number of ventilator-free days at 28 days after randomization.
Conditions
- Sedation
- Airway Extubation
Interventions
- DRUG
-
Isoflurane
Inhaled sedation with isoflurane via Sedaconda ACD-S
- DRUG
-
Propofol
Intravenous sedation with Propofol 20 mg/ml
Sponsors & Collaborators
-
Instituto de Salud Carlos III
collaborator OTHER_GOV -
Instituto de Investigación Hospital Universitario La Paz
lead OTHER
Principal Investigators
-
José M. Añón, MD, PhD · Hospital Universitario La Paz. IdiPAZ
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-15
- Primary Completion
- 2027-03-31
- Completion
- 2027-12-31
Countries
- Spain
Study Locations
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