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)

Sedana Medical

Status and phase: Active, not recruiting; Phase 3

Conditions: Sedation

Treatments: Drug: Propofol; Drug: Isoflurane

Study type: Interventional

Funder types: Industry

Identifiers

NCT05312385

SED003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 235 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

235 participants in 2 patient groups

Isoflurane

Experimental group

Description:

Inhaled isoflurane administered via Sedaconda ACD-S

Treatment:

Drug: Isoflurane

Propofol

Active Comparator group

Description:

Propofol administered as intravenous infusion

Treatment:

Drug: Propofol