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RECRUITING
NCT07000526
PHASE4

Inhaled Sedation in Critically Ill Patients

Sponsor: Instituto de Investigación Hospital Universitario La Paz

View on ClinicalTrials.gov

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.

Official title: Inhaled Sedation in Critically Ill Patients: a Multicentre Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

620

Start Date

2025-12-15

Completion Date

2027-12

Last Updated

2026-03-02

Healthy Volunteers

No

Interventions

DRUG

Isoflurane

Inhaled sedation with isoflurane via Sedaconda ACD-S

DRUG

Propofol

Intravenous sedation with Propofol 20 mg/ml

Locations (22)

Hospital Vega Baja

Orihuela, Alicante, Spain

Hospital Universitario Doctor José Molina Orosa

Arrecife, Lanzarote-Canary Islands, Spain

Hospital Universitario de Albacete

Albacete, Spain

Hospital Germans Trias i Pujol

Badalona, Spain

Corporacio Sanitaria Parc Taulí

Barcelona, Spain

Hospital Universitario de Bellvitge

Barcelona, Spain

Hospital Universitario Valle de Hebron

Barcelona, Spain

Hospital General Universitario Santa Lucía

Cartagena, Spain

Hospital Arnau de Vilanova

Lleida, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Univeritario Puerta de Hierro

Madrid, Spain

Hospital Universitario de Getafe

Madrid, Spain

Hospital Universitario de la Princesa

Madrid, Spain

Hospital Universitario Gregorio Marañon

Madrid, Spain

Hospital Universitario Infanta Leonor

Madrid, Spain

Hospital Universitario Rey Juan Carlos

Madrid, Spain

Hospital Reina Sofía

Murcia, Spain

Hospital Universitario Virgen de la Arrixaca

Murcia, Spain

Hospital Universitario Joan XXIII

Tarragona, Spain

Hospital Universitario de Toledo

Toledo, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

Hospital Universitario Rio Hortega

Valladolid, Spain