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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) (INSPiRE-ICU1)

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ClinicalTrials.gov Identifier: NCT05312385
Recruitment Status : Recruiting
First Posted : April 5, 2022
Last Update Posted : November 2, 2022
Sponsor:
Information provided by (Responsible Party):
Sedana Medical

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Sedation Drug: Isoflurane Drug: Propofol Phase 3

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 235 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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-ICU1)
Actual Study Start Date : April 28, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Isoflurane
Inhaled isoflurane administered via Sedaconda ACD-S
 Drug: Isoflurane
Inhaled isoflurane administered by Sedaconda ACD-S
Active Comparator: Propofol
Propofol administered as intravenous infusion
 Drug: Propofol
Intravenous infusion of propofol


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of time adequate sedation depth [ Time Frame: During study treatment up to 48 (±6) hours ]
    To compare the percentage of time sedation depth is maintained within the target range, in absence of rescue sedation, as assessed according to the RASS scale, in isoflurane- vs propofol-treated patients


Secondary Outcome Measures :
  1. Key Secondary: Compare the use of opioids [ Time Frame: During study treatment up to 48 (±6) hours ]
    To compare the effect of isoflurane vs propofol on use of opioids during the study drug treatment period measuring CPOT

  2. Key Secondary: Compare the wake up time [ Time Frame: End of study treatment (EOT) ]
    To compare the effect of isoflurane vs propofol on the wake up time at end of study drug treatment

  3. Key Secondary: Compare the cognitive recovery after EOT [ Time Frame: 60 minutes after EOT ]
    To compare the effect of isoflurane vs propofol on cognitive recovery after EOT by measuring CAM-ICU-7

  4. Key Secondary: Compare the spontaneous breathing effort [ Time Frame: During study treatment up to 48 (±6) hours ]

    To compare the effect of isoflurane vs propofol on spontaneous breathing effort during the study drug treatment period by measuring

    • Airway occlusion pressure, pressure support or if observed respiratory rate exceeds set respiratory rate


  5. Other secondary: Compare time from sedation termination to extubation [ Time Frame: During study treatment ]
    To compare the effect of isoflurane vs propofol on time from sedation termination to extubation in patients for whom study drug is terminated for extubation

  6. Other secondary: Compare days alive and free of mechanical ventilation through Study Day 30 [ Time Frame: From start of study treatment up to 30 days ]
    To compare the effect of isoflurane vs propofol on days alive and free of mechanical ventilation through Study Day 30

  7. Other secondary: Compare days alive and free of the ICU [ Time Frame: From start of study treatment up to 30 days ]
    To compare the effect of isoflurane vs propofol on days alive and free of the ICU

  8. Other secondary: Compare delirium and coma free days until 7 days after EOT [ Time Frame: From start of study treatment until 7 days after EOT ]
    To compare the effect of isoflurane vs propofol on delirium and coma free days until 7 days after EOT

  9. Other secondary: Compare mortality at 30 days after randomization [ Time Frame: Until 30 days after randomization ]
    To compare the effect of isoflurane vs propofol on mortality at 30 days after randomization

  10. Other secondary: Compare mortality at 3 months after randomization [ Time Frame: Until 3 months after randomization ]
    To compare the effect of isoflurane vs propofol on mortality at 3 months after randomization

  11. Other secondary: Compare mortality at 6 months after randomization [ Time Frame: Until 6 months after randomization ]
    To compare the effect of isoflurane vs propofol on mortality at 6 months after randomization

  12. Other secondary: To compare the safety profile of isoflurane vs propofol [ Time Frame: Baseline to end of study treatment, safety lab from baseline up to 48hrs post treatment, AEs from start study treatment up to day 30 ]
    To compare the safety profile of isoflurane vs propofol in respect to reported Adverse Event

  13. Other secondary: To assess Sedaconda ACD-S device deficiencies in patients receiving isoflurane [ Time Frame: During study treatment up to 48 (±6) hours ]
    To assess Sedaconda ACD-S device deficiencies in patients receiving isoflurane by Sedaconda ACD-S by reported Adverse Event

  14. Other secondary: To compare the use of restraints in patients receiving isoflurane vs propofol [ Time Frame: During study treatment up to 48 (±6) hours ]
    Incidence of restraints measured twice daily


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05312385


Contacts
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Contact: Magnus Falkenhav, M.D. +46 70 856 1687 magnus.falkenhav@sedanamedical.com

Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
United States, Illinois
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
The Brigham and Women´s Hospital Recruiting
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, Ohio
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
United States, Utah
Intermountain Health Care Health Services Not yet recruiting
Salt Lake City, Utah, United States, 84111
United States, Virginia
University of Virginia Not yet recruiting
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
Sedana Medical
Investigators
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Principal Investigator: Kimberly Rengel, M.D. Vanderbilt University Medical Center
More Information
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Additional Information:

Publications:

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Responsible Party: Sedana Medical
ClinicalTrials.gov Identifier: NCT05312385    
Other Study ID Numbers: SED003
First Posted: April 5, 2022    Key Record Dates
Last Update Posted: November 2, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sedana Medical:
sedation
mechanical ventilation
isoflurane
propofol
ICU
Additional relevant MeSH terms:
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Propofol
Isoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Inhalation