Inhaled Sedation in Critically Ill Patients

Recruiting now · Phase 4

Conditions studied: Sedation, Airway Extubation

In brief

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.

Key facts

Study ID

NCT07000526

Run by

Instituto de Investigación Hospital Universitario La Paz

People needed

620

Starts

2025-12-15

Expected to finish

2027-12-01

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Hospital Vega Baja — Orihuela, Alicante, Spain (enrolling)
• Hospital Universitario de Bellvitge — Barcelona, Spain (enrolling)
• Hospital Universitario Valle de Hebron — Barcelona, Spain (enrolling)
• Hospital Universitario La Paz — Madrid, Spain (enrolling)
• Hospital Universitario de la Princesa — Madrid, Spain (enrolling)
• Hospital Universitario Gregorio Marañon — Madrid, Spain (enrolling)
• Hospital Universitario Infanta Leonor — Madrid, Spain (enrolling)
• Hospital Universitario Rey Juan Carlos — Madrid, Spain (enrolling)
• Hospital Universitario Joan XXIII — Tarragona, Spain (enrolling)
• Hospital Clínico Universitario de Valencia — Valencia, Spain (enrolling)
• Hospital Universitario Rio Hortega — Valladolid, Spain (enrolling)
• Hospital Germans Trias i Pujol — Badalona, Spain (enrolling)
• Hospital Universitario Doctor José Molina Orosa — Arrecife, Lanzarote-Canary Islands, Spain
• Hospital Galdakao-Usansolo Ospitalea — Galdakao, Vizcaya, Spain
• Hospital Universitario de Albacete — Albacete, Spain
• Hospital Universitario Ramon y Cajal — Madrid, Spain
• Hospital Univeritario Puerta de Hierro — Madrid, Spain
• Hospital Regional Universitario de Málaga — Málaga, Spain
• Hospital Universitario de Jaen — Jaén, Spain
• Hospital Arnau de Vilanova — Lleida, Spain
• Hospital Universitario de Fuenlabrada — Madrid, Spain
• Hospital Universitario de Toledo — Toledo, Spain

Full record on ClinicalTrials.gov

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