Status:
RECRUITING
Inhaled Sedation in Critically Ill Patients
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
Sedation
Airway Extubation
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 receiv...
Detailed Description
Justification: Isoflurane has recently emerged as an attractive alternative for intensive care unit (ICU) sedation. Due to their favorable pharmaco-kinetic and dynamic profile, this agent has been pro...
Eligibility Criteria
Inclusion
- \- Adult patients receiving mechanical ventilation, with an anticipated duration \>48 hours after randomization, and requiring deep sedation (target RASS between -3 and -5).
Exclusion
- Contraindication to isoflurane or propofol
- Allergy to isoflurane or propofol
- Cardiopulmonary arrest
- History of ventricular tachycardia or long QT syndrome
- Tidal volume \< 300 mL or PaCO₂ \> 50 mmHg at the time of randomization.
- Invasive mechanical ventilation for more than 48 hours at the time of randomization.
- Pregnancy
- Breast feeding
- Acute neurological condition
- ECMO
- ECCO2R
- Active humidification strictly required
- Burns
- Lack of informed consent
Key Trial Info
Start Date :
December 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
620 Patients enrolled
Trial Details
Trial ID
NCT07000526
Start Date
December 15 2025
End Date
December 1 2027
Last Update
December 26 2025
Active Locations (22)
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1
Hospital Vega Baja
Orihuela, Alicante, Spain
2
Hospital Universitario Doctor José Molina Orosa
Arrecife, Lanzarote-Canary Islands, Spain, 35500
3
Hospital Universitario de Albacete
Albacete, Spain
4
Hospital Germans Trias i Pujol
Badalona, Spain