Overview

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)

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.