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Inhaled Anesthetic
Inhaled Isoflurane vs. IV Propofol for ICU Sedation (INSPiRE-ICU1 Trial)
Phase 3
Recruiting
Led By Kimberly Rengel, M.D.
Research Sponsored by Sedana Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who are anticipated to require >12 hours of invasive mechanical ventilation and continuous sedation in the ICU;
Receipt of continuous sedation due to clinical need for sedation to RASS <0
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during study treatment up to 48 (±6) hours
Awards & highlights
INSPiRE-ICU1 Trial Summary
This trial compares the safety and effectiveness of inhaling isoflurane vs. receiving propofol intravenously for sedation of people on mechanical ventilation in the ICU.
Who is the study for?
Adults over 18 who need mechanical ventilation and sedation for more than 12 hours in the ICU can join. They must require a specific level of sedation (RASS <0). Excluded are those with severe neurological issues, life-threatening conditions, allergies to isoflurane or propofol, certain heart problems, pregnant or breastfeeding women, and patients on other conflicting studies.Check my eligibility
What is being tested?
The trial compares two types of sedatives: inhaled isoflurane using Sedaconda ACD-S versus intravenous propofol. It aims to determine which one is safer and more effective for keeping ICU patients under sedation while they're on a ventilator.See study design
What are the potential side effects?
Isoflurane may cause coughing, nausea, vomiting or confusion; Propofol can lead to low blood pressure, pain at injection site or propofol infusion syndrome—a rare but serious condition affecting the heart and lungs.
INSPiRE-ICU1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am expected to need a breathing machine and sedation in the ICU for more than 12 hours.
Select...
I am on constant sedation due to my medical condition.
Select...
I am on constant sedation due to my medical condition.
Select...
I expect to need a breathing machine and sedation in the ICU for more than 12 hours.
Select...
I am 18 years old or older.
INSPiRE-ICU1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until 3 months after randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until 3 months after randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of time adequate sedation depth
Secondary outcome measures
Key Secondary: Compare the cognitive recovery after EOT
Key Secondary: Compare the spontaneous breathing effort
Key Secondary: Compare the use of opioids
+11 moreINSPiRE-ICU1 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: IsofluraneExperimental Treatment1 Intervention
Inhaled isoflurane administered via Sedaconda ACD-S
Group II: PropofolActive Control1 Intervention
Propofol administered as intravenous infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isoflurane
2010
Completed Phase 4
~53870
Find a Location
Who is running the clinical trial?
Sedana MedicalLead Sponsor
3 Previous Clinical Trials
352 Total Patients Enrolled
2 Trials studying Sedation
332 Patients Enrolled for Sedation
Kimberly Rengel, M.D.Principal InvestigatorVanderbilt University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic or cannot take propofol or isoflurane.I am receiving care focused on comfort, not curing my illness.I am not pregnant or breastfeeding.You are allergic to isoflurane or propofol, or have had a rare reaction called propofol infusion syndrome.I was sedated for more than 72 hours for a breathing machine before starting the study.I have a condition like ALS that affects my ability to breathe on my own.I expect to need a muscle relaxant infusion for more than 4 hours.You have a severe impairment in kidney function.I am 18 years old or older.I am expected to need a breathing machine and sedation in the ICU for more than 12 hours.I am on constant sedation due to my medical condition.I need strong medication to keep my blood pressure stable.I need a machine to help keep my air moist while I breathe.I am on constant sedation due to my medical condition.I need IV medication for seizures or withdrawal symptoms.I or someone in my family has a history of malignant hyperthermia.I require advanced breathing support.I was unable to participate in studies due to a severe neurological condition before ICU admission.I have a history of irregular heartbeats or Long QT Syndrome.I expect to need a breathing machine and sedation in the ICU for more than 12 hours.I am 18 years old or older.
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Isoflurane
- Group 2: Propofol
Sedation Patient Testimony for trial: Trial Name: NCT05312385 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please give me an estimate of how many different locations are conducting this trial?
"There are 11 available for this clinical trial such as MD Anderson Cancer Center in Houston, University of Colorado Anschutz Medical Campus in Aurora, and University of Chicago in Chicago. A full list of the other locations can be found on the clinical trials website."
Answered by AI
Is Isoflurane an accepted medical treatment by the FDA?
"Isoflurane is considered safe based on the available evidence from Phase 3 clinical trials."
Answered by AI
How many people are being given the opportunity to participate in this clinical trial?
"In order to carry out this clinical trial, we need 235 patients that fit the given inclusion criteria. Those who are interested in participating can do so at MD Anderson Cancer Center in Houston, Texas or University of Colorado Anschutz Medical Campus in Aurora, Colorado."
Answered by AI
Are volunteers still being sought for this research project?
"That is correct. The most recent information on clinicaltrials.gov reveals that this study is looking for235 individuals to take part in the 11 different locations. This experiment was originally posted on April 28th, 2020 and edited November 1st, 2020."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Tennessee
Utah
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
University of Chicago
MD Anderson Cancer Center
Other
Intermountain Health Care Health Services
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
Methodist is a great hospital! I’ve been sedated many times, I’d like to see if this new drug will improve waking up from sedation.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Is compensation for time/travel provided?
PatientReceived no prior treatments
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