Inhaled isoflurane versus IV propofol for sedation of ventilated ICU patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, phase 4 trial assigns adult ICU patients 1:1 to inhaled isoflurane via the Sedaconda ACD‑S device or to standard intravenous propofol for deep sedation. The primary outcome is ventilator-free days at 28 days after randomization, with key secondary outcomes including ICU-free days, time to extubation after sedation withdrawal, and adequacy of sedation. Eligible patients are adults on invasive mechanical ventilation expected to need more than 48 hours of ventilation with a target RASS between -3 and -5 and without contraindications such as ECMO, pregnancy, or severe respiratory derangements. The trial emphasizes longer sedation periods to address gaps left by earlier short-duration studies of inhaled ICU sedation.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital Vega Baja
  Orihuela, Alicante, Spain 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 La Paz
  Madrid, Spain Recruiting
• Hospital Universitario de la Princesa
  Madrid, Spain Recruiting

Study contacts

• Principal investigator: José M. Añón, MD, PhD — Hospital Universitario La Paz. IdiPAZ
• Study coordinator: José M. Añón, MD, PhD
• Email: jmaelizalde@gmail.com
• Phone: +(34) 912071307

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.