Inhaled Sedation in Critically Ill Patients
IS-CRITIC
2 other identifiers
interventional
620
1 country
22
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2025
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2025
CompletedFirst Posted
Study publicly available on registry
June 3, 2025
CompletedStudy Start
First participant enrolled
December 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 2, 2026
February 1, 2026
1.2 years
May 22, 2025
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ventilator-free days at day 28 from randomization
Number of days between randomization and day 28 during which the patient is alive and free from invasive mechanical ventilation. Patients who die before day 28, or who remain on mechanical ventilation at day 28, are assigned zero ventilator-free days.
From randomization until day 28
Secondary Outcomes (9)
Key secondary objective: ICU-free days at day 28 post-randomization
From randomization until day 28
Time to extubation
From randomization until day 28
Administration of rescue sedation
From randomization until day 28
Sedation efficacy
From randomization until extubation or day 28
Number of Participants With Delirium
From randomization until extubation or day 28
- +4 more secondary outcomes
Study Arms (2)
Study group
EXPERIMENTALInhaled sedation with Isoflurane. Initial dose: 3 mL/h. Gradual dose increase until target RASS is achieved. Do not exceed 14 mL/h. Guided by end tidal isoflurane concentration (EtISO), the recommended maximum dose for prolonged use is 1%. Short periods at up to 1.5% may be considered. If the target RASS is not achieved at the maximum dose, a second hypnotic agent may be added.
Control group
ACTIVE COMPARATORIntravenous sedation with propofol (20 mg/mL). Initial dose: 0.5-1 mg/kg/h. Gradual dose increase until target RASS is achieved. Do not exceed 4 mg/kg/h. If the target RASS is not achieved at the maximum dose, a second hypnotic agent may be added.
Interventions
Inhaled sedation with isoflurane via Sedaconda ACD-S
Intravenous sedation with Propofol 20 mg/ml
Eligibility Criteria
You may qualify if:
- \- Adult patients receiving mechanical ventilation, with an anticipated duration \>48 hours after randomization, and requiring deep sedation (target RASS between -3 and -5).
You may not qualify if:
- 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
- Patients expected to require repeated surgical interventions during their ICU stay.
- ECMO
- ECCO2R
- Active humidification strictly required
- Neuromuscular disease or high spinal cord injury likely to prevent discontinuation of mechanical ventilation due to baseline condition
- Requirement for benzodiazepine use for a specific indication
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Hospital Vega Baja
Orihuela, Alicante, Spain
Hospital Universitario Doctor José Molina Orosa
Arrecife, Lanzarote-Canary Islands, 35500, 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, 28029, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
José M. Añón, MD, PhD
Hospital Universitario La Paz. IdiPAZ
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Department of Critical Care Medicine
Study Record Dates
First Submitted
May 22, 2025
First Posted
June 3, 2025
Study Start
December 15, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
March 2, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share