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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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
* Allergy to isoflurane or propofol
* Cardiopulmonary arrest
* History of ventricular tachycardia or long QT syndrome
* Tidal volume \< 300 mL or PaCOâ‚‚ \> 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
What they're measuring
1
Ventilator-free days at day 28 from randomization
Timeframe: From randomization until day 28
Trial details
NCT IDNCT07000526
SponsorInstituto de Investigación Hospital Universitario La Paz