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Inhaled Anesthetic
Inhaled Isoflurane vs. IV Propofol for ICU Sedation (INSPiRE-ICU1 Trial)
Phase 3
Waitlist Available
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
Must not have
Contraindication to propofol or isoflurane
Comfort care only (end of life care)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until 3 months after randomization
Awards & highlights
Summary
This trial is testing whether inhaling a sedative gas called isoflurane through a special device is as safe and effective as the usual methods for adults in the ICU who need help breathing with a machine. Isoflurane has shown better control of intensive care sedation and seems to be a useful alternative.
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am allergic or cannot take propofol or isoflurane.
Select...
I am receiving care focused on comfort, not curing my illness.
Select...
I am not pregnant or breastfeeding.
Select...
I was sedated for more than 72 hours for a breathing machine before starting the study.
Select...
I have a condition like ALS that affects my ability to breathe on my own.
Select...
I expect to need a muscle relaxant infusion for more than 4 hours.
Select...
I need strong medication to keep my blood pressure stable.
Select...
I need a machine to help keep my air moist while I breathe.
Select...
I need IV medication for seizures or withdrawal symptoms.
Select...
I or someone in my family has a history of malignant hyperthermia.
Select...
I require advanced breathing support.
Select...
I was unable to participate in studies due to a severe neurological condition before ICU admission.
Select...
I have a history of irregular heartbeats or Long QT Syndrome.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of time adequate sedation depth
Secondary study objectives
Key Secondary: Compare the cognitive recovery after EOT
Key Secondary: Compare the spontaneous breathing effort
Key Secondary: Compare the use of opioids
+11 moreTrial 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common sedation treatments, such as inhaled isoflurane and intravenous propofol, primarily work by enhancing the activity of the inhibitory neurotransmitter GABA in the central nervous system, leading to CNS depression and sedation. Isoflurane, administered via the Sedaconda ACD-S device, and propofol both reduce excitatory neurotransmitter activity, which helps achieve the desired sedative effect.
This understanding is essential for optimizing sedation protocols, ensuring patient safety, and improving outcomes in mechanically ventilated patients in ICU settings.
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
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