Gender
All
Age Group
18 Years and up
Accepting 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.
