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Inhaled sedation in the critically ill patient
EU CTIS ID: 2024-518521-14-00
What this study is testing
To compare the days free of mechanical ventilation in patients receiving sedation with isoflurane versus those receiving intravenous sedation with propofol in critically ill patients in whom more than 48 hours of invasive mechanical ventilation are expected.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age equal to or greater than 18 years
- Mechanically ventilated patients in whom a minimum mechanical ventilation time of 48 hours from randomization is expected.
- Patients in whom it is necessary to maintain a RASS between -3 and -5.
You likely can't join if
- Contraindication for isoflurane or propofol.
- Acute neurological pathology (head trauma, intraparenchymal hemorrhage, subarachnoid hemorrhage or post-operative neurosurgery).
- Any type of disorder (blindness, deafness, dementia) or language barrier that prevents the completion of the scales for the assessment of delirium or cognitive assessment.
- Life expectancy of less than 48 hours or patients with such a level of severity that death during admission to the ICU is considered highly probable.
- Patients in whom repeated surgical interventions are expected during their stay in the ICU.
- Patients with extracorporeal oxygenation system (ECMO).
See the full eligibility criteria
- Age equal to or greater than 18 years
- Mechanically ventilated patients in whom a minimum mechanical ventilation time of 48 hours from randomization is expected.
- Patients in whom it is necessary to maintain a RASS between -3 and -5.
- Contraindication for isoflurane or propofol.
- Acute neurological pathology (head trauma, intraparenchymal hemorrhage, subarachnoid hemorrhage or post-operative neurosurgery).
- Any type of disorder (blindness, deafness, dementia) or language barrier that prevents the completion of the scales for the assessment of delirium or cognitive assessment.
- Life expectancy of less than 48 hours or patients with such a level of severity that death during admission to the ICU is considered highly probable.
- Patients in whom repeated surgical interventions are expected during their stay in the ICU.
- Patients with extracorporeal oxygenation system (ECMO).
- Mandatory need for active humidification.
- Need for benzodiazepine use due to a specific indication (e.g., withdrawal syndrome).
- Neuromuscular disease or high spinal cord injury that may prevent weaning from mechanical ventilation due to baseline condition.
- Lack of informed consent.
- Patients with extracorporeal CO2 extraction system (ECCO2R).
- Critical burn patients.
- Patients admitted due to recovered cardiorespiratory arrest.
- History of ventricular tachycardia/long QT syndrome.
- Patients who have remained on mechanical ventilation for more than 48 hours at the time of randomization.
- Tidal volume less than 300 ml or PaCO2 greater than 50 mm Hg at the time of randomization.
- Pregnancy.
- History of allergy or intolerance to isoflurane.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.