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)

Trial ID or NCT#

NCT05327296

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

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 Adult Patients (INSPiRE-ICU2)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.
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Investigator(s)

Javier Lorenzo
Javier Lorenzo
Anesthesiologist
Clinical Associate Professor, Anesthesiology, Perioperative and Pain Medicine

View on ClinicalTrials.gov