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General Anesthetic
Inhaled Isoflurane vs IV Propofol for Sedation (INSPiRE-ICU2 Trial)
Phase 3
Recruiting
Led By Jeremy Beitler, 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
Receipt of continuous sedation due to clinical need for sedation to RASS <0
Patients who are anticipated to require >12 hours of invasive mechanical ventilation and continuous sedation in the ICU
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of study treatment, safety lab from baseline up to 48hrs post treatment, aes from start study treatment up to day 30
Awards & highlights
INSPiRE-ICU2 Trial Summary
This trial is testing if a new way to give anesthesia is as good as the standard way. The new way is inhaling isoflurane through a machine, and the standard way is through an IV.
Who is the study for?
Adults over 18 who need mechanical ventilation and sedation in the ICU for more than 12 hours can join. Excluded are those with allergies to isoflurane or propofol, certain severe neurological or muscular conditions, extreme hemodynamic instability, a history of malignant hyperthermia (MH), ventricular tachycardia/Long QT Syndrome, or on specific other treatments.Check my eligibility
What is being tested?
The trial compares two sedation methods for ICU patients on ventilators: inhaling isoflurane using Sedaconda ACD-S versus receiving propofol intravenously. It aims to determine which method is safer and more effective.See study design
What are the potential side effects?
Isoflurane may cause respiratory issues like coughing or wheezing, while propofol can lead to low blood pressure, pain at the injection site, and in rare cases, Propofol Infusion Syndrome with heart failure.
INSPiRE-ICU2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on constant sedation due to my medical condition.
Select...
I am expected to need a breathing machine and sedation in the ICU for more than 12 hours.
Select...
I am 18 years old or older.
INSPiRE-ICU2 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-ICU2 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
Jeremy Beitler, M.D.Principal InvestigatorColumbia University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic or cannot take propofol or isoflurane.I have a history of irregular heartbeats or Long QT Syndrome.I am on constant sedation due to my medical condition.I will need a muscle relaxant treatment for more than 4 hours.I or someone in my family has a history of malignant hyperthermia.I need IV medication for seizures or withdrawal symptoms.I have a condition like ALS that affects my ability to breathe on my own.I am currently pregnant or breastfeeding.I was sedated for more than 72 hours for a breathing machine before starting the study.I require advanced support for my breathing at screening.I need strong medication to keep my blood pressure stable.I am expected to need a breathing machine and sedation in the ICU for more than 12 hours.I need a machine to help keep my airways moist while I breathe.I was able to participate in studies before my ICU admission.I am 18 years old or older.I am receiving care focused on comfort, not curing my illness.
Research Study Groups:
This trial has the following groups:- Group 1: Isoflurane
- Group 2: Propofol
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there many locations where this clinical trial is taking place within the state?
"Beth Israel Deaconess Medical Center in Redwood City, California, Stanford University in Columbus, Ohio and Ohio State University in New york City are all currently enrolling patients for this trial. There are also 9 other sites across the country where patients can participate."
Answered by AI
How many willing participants are required for this research project?
"In order to move forward, this study requires 235 participants that meet the given eligibility requirements. Beth Israel Deaconess Medical Center in Redwood City, California and Stanford University in Columbus, Ohio are two of the many sites where patients can take part in this research."
Answered by AI
What is the FDA's stance on Isoflurane?
"Isoflurane is considered safe based on its Phase 3 status and past clinical data."
Answered by AI
Are people with the relevant conditions able to participate in this trial right now?
"The listing on clinicaltrials.gov verifies that this study is still recruiting patients. With 9 different enrolment sites, the trial has recruited 235 individuals to date since first being posted on June 30th, 2022."
Answered by AI
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