Inhaled Sedation in Critically Ill Patients

Recruiting Phase 4 Interventional Study
Sedation Airway Extubation
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
620 (estimated)
Sponsor
Instituto de Investigación Hospital Universitario La Paz · Other
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About This Trial
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 day…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: \- Adult patients receiving mechanical ventilation, with an anticipated duration \>48 hours after randomization, and requiring deep sedation (target RASS between -3 and -5). Exclusion Criteria: * Contraindication to isoflurane or propofol * Patients with maternal ancestry from…
Contacts

José M. Añón, MD, PhD

+(34) 912071307

jmaelizalde@gmail.com

CONTACT