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Clinical Trials in Spain / NCT07000526
Recruiting Phase 4

Inhaled Sedation in Critically Ill Patients

NCT07000526 · tracked via the Priya Life Science Spain tracker
Phase
Phase 4
Started
2025-12-15
Last updated
2026-06-29

Condition(s) studied

SedationAirway Extubation

Investigational drug(s) / intervention(s)

Isoflurane →Propofol →

Isoflurane: Inhaled sedation with isoflurane via Sedaconda ACD-S

Propofol: Intravenous sedation with Propofol 20 mg/ml

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 Venezuela, due to the potential presence of an mt-ND4 gene mutation associated with neurological injury after exposure to certain volatile anaesthetic agents * Significant air leak, defined as a leak exceeding 30% of the delivered minute ventilation * 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 * Burns * Life expectancy less than 48 hours, or patients with such a level of severity that death during the ICU stay is considered highly likely. * Any condition (e.g., blindness, deafness, dementia) or language barrier that prevents the administration of delirium or cognitive assessment scales. * Lack of informed consent

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
Hospital Vega Baja Orihuela Alicante Recruiting
Hospital Universitario Doctor José Molina Orosa Arrecife Lanzarote-Canary Islands Not Yet Recruiting
Hospital Galdakao-Usansolo Ospitalea Galdakao Vizcaya Not Yet Recruiting
Hospital Universitario de Albacete Albacete Spain Not Yet Recruiting
Hospital Germans Trias i Pujol Badalona Spain Recruiting
Hospital Universitario de Bellvitge Barcelona Spain Recruiting
Hospital Universitario Valle de Hebron Barcelona Spain Recruiting
Hospital Universitario de Jaen Jaén Spain Not Yet Recruiting
Hospital Arnau de Vilanova Lleida Spain Not Yet Recruiting
Hospital Universitario de Fuenlabrada Madrid Spain Not Yet Recruiting
Hospital Universitario La Paz Madrid Spain Recruiting
Hospital Universitario Ramon y Cajal Madrid Spain Not Yet Recruiting
Hospital Univeritario Puerta de Hierro Madrid Spain Not Yet Recruiting
Hospital Universitario de la Princesa Madrid Spain Recruiting
Hospital Universitario Gregorio Marañon Madrid Spain Recruiting
Hospital Universitario Infanta Leonor Madrid Spain Recruiting
Hospital Universitario Rey Juan Carlos Madrid Spain Recruiting
Hospital Regional Universitario de Málaga Málaga Spain Not Yet Recruiting
Hospital Universitario Joan XXIII Tarragona Spain Recruiting
Hospital Universitario de Toledo Toledo Spain Not Yet Recruiting
Hospital Clínico Universitario de Valencia Valencia Spain Recruiting
Hospital Universitario Rio Hortega Valladolid Spain Recruiting

More Instituto de Investigación Hospital Universitario La Paz trials in Spain

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07000526 on ClinicalTrials.gov ↗ ← All trials in Spain