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Inhaled Sedation in Critically Ill Patients

RecruitingPhase 4Ages 18 Years - 80 YearsAllInstituto de Investigación Hospital Universitario…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Isoflurane
  • Propofol
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Where

22 sites
Hospital Vega Baja
Orihuela, Spain
Hospital Universitario Doctor José Molina Orosa
Arrecife, Spain
Hospital Galdakao-Usansolo Ospitalea
Galdakao, Spain
Hospital Universitario de Albacete
Albacete, Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Universitario de Bellvitge
Barcelona, Spain
Hospital Universitario Valle de Hebron
Barcelona, Spain
Hospital Universitario de Jaen
Jaén, Spain

…and 14 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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