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)
- Registration Number
- NCT05327296
- Lead Sponsor
- Sedana Medical
- 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 the Intensive Care Unit (ICU) setting.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 235
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Propofol Propofol Propofol administered as intravenous infusion Isoflurane Isoflurane Inhaled isoflurane administered via Sedaconda ACD-S
- Primary Outcome Measures
Name Time Method Percentage of time adequate sedation depth During study treatment up to 48 (±6) hours To compare the percentage of time sedation depth is maintained within the target range, in absence of rescue sedation, as assessed according to the RASS scale, in isoflurane- vs propofol-treated patients
- Secondary Outcome Measures
Name Time Method Key Secondary: Compare the cognitive recovery after EOT 60 minutes after EOT To compare the effect of isoflurane vs propofol on cognitive recovery after EOT by measuring CAM-ICU-7
Other secondary: Compare delirium and coma free days until 7 days after EOT From start of study treatment until 7 days after EOT To compare the effect of isoflurane vs propofol on delirium and coma free days until 7 days after EOT
Other secondary: Compare mortality at 30 days after randomization Until 30 days after randomization To compare the effect of isoflurane vs propofol on mortality at 30 days after randomization
Other secondary: To compare the safety profile of isoflurane vs propofol Baseline to end of study treatment, safety lab from baseline up to 48hrs post treatment, AEs from start study treatment up to day 30 To compare the safety profile of isoflurane vs propofol in respect to reported Adverse Event
Key Secondary: Compare the wake up time Time from stop of study drug treatment up to 4 hours To compare the effect of isoflurane vs propofol on the wake up time at end of study drug treatment
Key Secondary: Compare the spontaneous breathing effort During study treatment up to 48 (±6) hours To compare the effect of isoflurane vs propofol on spontaneous breathing effort during the study drug treatment period by measuring
• Airway occlusion pressure, pressure support or if observed respiratory rate exceeds set respiratory rateOther secondary: Compare time from sedation termination to extubation During study treatment To compare the effect of isoflurane vs propofol on time from sedation termination to extubation in patients for whom study drug is terminated for extubation
Key Secondary: Compare the use of opioids During study treatment up to 48 (±6) hours To compare the effect of isoflurane vs propofol on use of opioids during the study drug treatment period measuring CPOT
Other secondary: Compare days alive and free of mechanical ventilation through Study Day 30 From start of study treatment up to 30 days To compare the effect of isoflurane vs propofol on days alive and free of mechanical ventilation through Study Day 30
Other secondary: Compare days alive and free of the ICU From start of study treatment up to 30 days To compare the effect of isoflurane vs propofol on days alive and free of the ICU
Other secondary: To assess Sedaconda ACD-S device deficiencies in patients receiving isoflurane During study treatment up to 48 (±6) hours To assess Sedaconda ACD-S device deficiencies in patients receiving isoflurane by Sedaconda ACD-S by reported Adverse Event
Other secondary: To compare the use of restraints in patients receiving isoflurane vs propofol During study treatment up to 48 (±6) hours Incidence of restraints measured twice daily
Other secondary: Compare mortality at 3 months after randomization Until 3 months after randomization To compare the effect of isoflurane vs propofol on mortality at 3 months after randomization
Other secondary: Compare mortality at 6 months after randomization Until 6 months after randomization To compare the effect of isoflurane vs propofol on mortality at 6 months after randomization
Trial Locations
- Locations (16)
Memorial Health Services
🇺🇸Long Beach, California, United States
University of Miami
🇺🇸Coral Gables, Florida, United States
The New York and Presbyterian Hospital
🇺🇸New York, New York, United States
The Cooper Health System
🇺🇸Camden, New Jersey, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Stanford University
🇺🇸Redwood City, California, United States
University of California, San Diego
🇺🇸San Diego, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Memorial Hermann Health Services
🇺🇸Houston, Texas, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States