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.
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