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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)

S

Sedana Medical

Status and phase

Active, not recruiting
Phase 3

Conditions

Sedation

Treatments

Drug: Propofol
Drug: Isoflurane

Study type

Interventional

Funder types

Industry

Identifiers

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

Trial contacts and locations

14

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Central trial contact

Magnus Falkenhav, M.D.

Data sourced from clinicaltrials.gov

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