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)

About

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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.