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.
INSPiRE-ICU 1
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)
Intensive care
All genders
18+
Recruiting now
Overview
Principal Investigator: Nicholas Hill, MD
Contact Us
Daniel Strick
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)