Actively Recruiting
Inhaled Sedation in Critically Ill Patients
Led by Instituto de Investigación Hospital Universitario La Paz · Updated on 2026-03-02
620
Participants Needed
22
Research Sites
102 weeks
Total Duration
On this page
Sponsors
I
Instituto de Investigación Hospital Universitario La Paz
Lead Sponsor
I
Instituto de Salud Carlos III
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Inhaled Sedation in Critically Ill Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients receiving mechanical ventilation, with an anticipated duration greater than 48 hours after randomization
- Patients requiring deep sedation with a target Richmond Agitation Sedation Scale (RASS) score between -3 and -5
You will not qualify if you...
- Contraindication or allergy to isoflurane or propofol
- Cardiopulmonary arrest
- History of ventricular tachycardia or long QT syndrome
- Tidal volume less than 300 mL or PaCO2 greater than 50 mmHg at randomization
- Invasive mechanical ventilation for more than 48 hours at randomization
- Pregnancy or breastfeeding
- Acute neurological condition
- Expected need for repeated surgical interventions during ICU stay
- Use of ECMO or ECCO2R
- Requirement for active humidification
- Neuromuscular disease or high spinal cord injury likely to prevent ventilator discontinuation
- Requirement for benzodiazepine use for a specific indication
- Burns
- Life expectancy less than 48 hours or very high risk of death during ICU stay
- Any condition or language barrier preventing delirium or cognitive assessment
- Lack of informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Hospital Vega Baja
Orihuela, Alicante, Spain
Actively Recruiting
2
Hospital Universitario Doctor José Molina Orosa
Arrecife, Lanzarote-Canary Islands, Spain, 35500
Not Yet Recruiting
3
Hospital Universitario de Albacete
Albacete, Spain
Not Yet Recruiting
4
Hospital Germans Trias i Pujol
Badalona, Spain
Not Yet Recruiting
5
Corporacio Sanitaria Parc Taulí
Barcelona, Spain
Not Yet Recruiting
6
Hospital Universitario de Bellvitge
Barcelona, Spain
Not Yet Recruiting
7
Hospital Universitario Valle de Hebron
Barcelona, Spain
Actively Recruiting
8
Hospital General Universitario Santa Lucía
Cartagena, Spain
Not Yet Recruiting
9
Hospital Arnau de Vilanova
Lleida, Spain
Not Yet Recruiting
10
Hospital Universitario La Paz
Madrid, Spain, 28029
Actively Recruiting
11
Hospital Univeritario Puerta de Hierro
Madrid, Spain
Not Yet Recruiting
12
Hospital Universitario de Getafe
Madrid, Spain
Not Yet Recruiting
13
Hospital Universitario de la Princesa
Madrid, Spain
Actively Recruiting
14
Hospital Universitario Gregorio Marañon
Madrid, Spain
Not Yet Recruiting
15
Hospital Universitario Infanta Leonor
Madrid, Spain
Actively Recruiting
16
Hospital Universitario Rey Juan Carlos
Madrid, Spain
Actively Recruiting
17
Hospital Reina Sofía
Murcia, Spain
Not Yet Recruiting
18
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain
Not Yet Recruiting
19
Hospital Universitario Joan XXIII
Tarragona, Spain
Not Yet Recruiting
20
Hospital Universitario de Toledo
Toledo, Spain
Not Yet Recruiting
21
Hospital Clínico Universitario de Valencia
Valencia, Spain
Actively Recruiting
22
Hospital Universitario Rio Hortega
Valladolid, Spain
Actively Recruiting
Research Team
J
José M. Añón, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here