Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
Sedana Medical
Conditions:
Sedation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
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 intra...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT05327296
Start Date
June 30 2022
End Date
December 30 2024
Last Update
June 6 2024
Active Locations (16)
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1
Memorial Health Services
Long Beach, California, United States, 90807
2
University of California, Los Angeles
Los Angeles, California, United States, 90095
3
Stanford University
Redwood City, California, United States, 94063
4
University of California, San Diego
San Diego, California, United States, 92023