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-ICU2)
Purpose
This is a study to compare safety and efficacy of inhaled isoflurane administered via the Sedaconda ACD-S device system versus intravenous propofol for sedation of mechanically ventilated patients in the Intensive Care Unit (ICU) setting.
Condition
- Sedation
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adults ≥18 years of age; - Patients who are anticipated to require >12 hours of invasive mechanical ventilation and continuous sedation in the ICU; and - Receipt of continuous sedation due to clinical need for sedation to RASS <0.
Exclusion Criteria
- Need for RASS -5; - Sedation for invasive mechanical ventilation immediately prior to Baseline for >72 hours; - Severe neurological condition before ICU admission that causes the patient to lack ability to participate in the study (ie, unable to be assessed for RASS and CPOT); - Ventilator tidal volume <200 or >1000 mL at Baseline; - Need for extracorporeal membrane oxygenation (ECMO), extracorporeal CO2 removal (ECCO2R), high frequency oscillation ventilation (HFOV), or high frequency percussive ventilation (HFPV) at Screening; - Comfort care only (end of life care); - Contraindication to propofol or isoflurane; - Known or family history of MH; - Severe hemodynamic compromise, defined as the need for norepinephrine ≥0.3 mcg/kg/min (or equivalent vasopressor dose) to maintain blood pressure within acceptable range, assumed to be mean arterial pressure ≥65 mmHg unless prescribed clinically; - Allergy to isoflurane or propofol, or have propofol infusion syndrome. - History of ventricular tachycardia/Long QT Syndrome; - Requirement of IV benzodiazepine or barbiturate administration for seizures or dependencies, including alcohol withdrawal - Neuromuscular disease that impairs spontaneous ventilation (eg, C5 or higher spinal cord injury, amyotrophic lateral sclerosis, etc); - Concurrent enrollment in another study that, in the Investigator's opinion, would impact the patient's safety or assessments of this study; - Participation in other study involving investigational drug(s) or devices(s) within 30 days prior to Randomization; - Anticipated requirement of treatment with continuous infusion of a neuromuscular blocking agent for >4 hours; - Female patients who are pregnant or breast-feeding; - Imperative need for continuous active humidification through mechanical ventilation circuit; - Attending physician's refusal to include the patient; or - Inability to obtain informed consent.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Isoflurane |
Inhaled isoflurane administered via Sedaconda ACD-S |
|
|
Active Comparator Propofol |
Propofol administered as intravenous infusion |
|
Recruiting Locations
Memorial Hermann Health Services
Houston, Texas 77030
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- Sedana Medical
Detailed Description
This is 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 (ICU) adult patients.