Clinical trial
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)
Name
SED004
Description
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.
Trial arms
Trial start
2022-06-30
Estimated PCD
2024-06-30
Trial end
2024-12-30
Status
Recruiting
Phase
Early phase I
Treatment
Isoflurane
Inhaled isoflurane administered by Sedaconda ACD-S
Arms:
Isoflurane
Propofol
Intravenous infusion of propofol
Arms:
Propofol
Size
235
Primary endpoint
Percentage of time adequate sedation depth
During study treatment up to 48 (±6) hours
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 235, 'type': 'ESTIMATED'}}
Updated at
2024-03-20
1 organization
2 products
1 indication
Product
IsofluraneIndication
SedationOrganization
Sedana MedicalProduct
Propofol