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-ICU1)

• Status: Not yet recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sedana Medical
• Treatments: Isoflurane; Propofol

Criteria

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.