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Title A Phase 3, Multicenter, Randomized, Controlled, Open Label, Assessor-Blinded Study to Evaluate the Efficacy and Safety of Inhaled Isoflurane Delivered via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU 1)
Therapeutic Area Intensive Care
Principal Investigator Nicholas Hill, MD
Min Age 18 Years
Gender Any
Contact Daniel Strick


This study aims to compare the effects of inhaled isoflurane sedation with the standard of care IV sedative propofol. Patients enrolled on this study will be on a ventilator (breathing machine) for more than 12 hours and require continuous sedation to keep the patient comfortable which can range from a state of drowsiness and relaxtion to a state of unconsciousness. The study drug, inhaled isoflurane, has been approved for use during surgery and is routinely used in this setting but this study will evaluate the drug as a general ICU sedative and it will be delivered through the Sedaconda ACD-S device which connects to the breathing tube.

Study Details

Inclusion Criteria

  • Patients who are expected to need more than 12 hours of invasive mechanical ventilation and continuous sedation in the ICU

Exclusion Criteria

  • Sedation for invasive mechanical ventilation for more than 72 hours before baseline
  • Severe neurological condition before ICU admission
  • End of life care

Study Requirements

The study will last up to 54 hours and you will be monitored in the hospital for up to 7 days. Your data will be collected after 1 month of your hospital course and you will be contacted at 3 and 6 months after your study treatment to ask you about your quality of life.

Additional study assessments:

  • Blood smaples will drawn from your existing lines (4 tablespoons in total)