Inhaled Isoflurane vs. IV Propofol for ICU Sedation
(INSPiRE-ICU1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two sedation methods for ICU patients requiring a ventilator and continuous sedation. It tests inhaled isoflurane, delivered through a special device, against intravenous propofol to determine which is safer and more effective. Suitable candidates for this trial are those on a ventilator needing sedation for over 12 hours in the ICU. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to the development of safer and more effective sedation methods.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you require IV benzodiazepines or barbiturates for seizures or dependencies, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that inhaled isoflurane might be safer for ICU patients. Studies have found that it can help patients wake up faster and leave the ICU sooner compared to drugs given through an IV. Earlier research suggests that patients using isoflurane had a 5% lower chance of dying within 30 days compared to those using other sedatives.
For propofol, the safety information is mixed. Some studies highlight its benefits, such as a lower risk of death and quicker ICU discharges. However, propofol also carries risks, including heart problems and a rare but serious condition called propofol infusion syndrome (PRIS), which can be severe.
In summary, both treatments have been used safely in many cases, but each also has specific risks. These factors are important to consider when thinking about joining a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because Isoflurane and Propofol offer different approaches to ICU sedation. Unlike the standard intravenous sedation with Propofol, Isoflurane is inhaled using a device called the Sedaconda ACD-S. This inhalation method could provide more precise control over sedation levels and potentially faster recovery times for patients. Additionally, Isoflurane's distinct method of administration might reduce some of the side effects associated with IV sedation, making it a promising alternative for patient care in intensive care units.
What evidence suggests that this trial's treatments could be effective for ICU sedation?
This trial will compare inhaled isoflurane with intravenous propofol for sedation in ICU patients. Research has shown that inhaled isoflurane may offer advantages over intravenous propofol. Studies have found that patients using inhaled isoflurane tend to wake up faster and can be taken off a ventilator sooner. Specifically, one study discovered that the 30-day death rate was 5% lower for patients using isoflurane compared to those using propofol. This suggests that isoflurane might lead to better outcomes for some patients in critical care.678910
Who Is on the Research Team?
Kimberly Rengel, M.D.
Principal Investigator
Vanderbilt University Medical Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either inhaled isoflurane via Sedaconda ACD-S or intravenous propofol for sedation while mechanically ventilated in the ICU
Follow-up
Participants are monitored for safety and effectiveness after treatment, including mortality and cognitive recovery assessments
Long-term follow-up
Participants' mortality and other outcomes are assessed at 3 and 6 months post-randomization
What Are the Treatments Tested in This Trial?
Interventions
- Isoflurane
- Propofol
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Inhaled isoflurane administered via Sedaconda ACD-S
Propofol administered as intravenous infusion
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sedana Medical
Lead Sponsor
Published Research Related to This Trial
Citations
Safety and effectiveness of inhaled sedation in critically ill ...
Main results: Fifteen trials with a total of 1185 patients were included, including 568 in the inhaled sedation group and 617 in the intravenous ...
Safety and effectiveness of inhaled sedation in critically ill ...
Inhaled sedation has advantages over intravenous sedation in terms of awakening time, extubation time, and ICU LOS (non-cardiac ICU).
A Pooled Analysis of Long-Term Outcomes After Inhaled ...
A Pooled Analysis of Long-Term Outcomes After Inhaled Isoflurane Via the Sedaconda ACD-S Compared to Intravenous Propofol. ClinicalTrials.gov ID NCT06809218.
Volatile sedation in critically ills adults undergoing mechanical ...
propofol for ICU sedation and found that 30-day mortality was 5% lower in the isoflurane group (unpublished data available on clinicaltrials.gov ...
NCT05312385 | Efficacy and Safety of Inhaled Isoflurane ...
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 ...
Propofol in ICU Settings: Understanding and Managing Anti ...
This review concisely summarizes the dual arrhythmic cardiovascular effects of propofol and a rare but serious complication, propofol infusion syndrome (PRIS).
an updated meta-analysis of randomized clinical trials
A statistically significant mortality increase in the propofol group was confirmed in subgroups of cardiac surgery, adult patients, volatile ...
American Journal of Respiratory and Critical Care Medicine
Patients treated with propofol had a reduced risk of mortality and had both an increased likelihood of earlier ICU discharge and earlier discontinuation of ...
Dexmedetomidine or Propofol for Sedation in Mechanically ...
Trials comparing dexmedetomidine with benzodiazepines in adults have shown that the use of dexmedetomidine results in improvement in outcomes ...
A systematic review and meta-analysis of propofol versus ...
Sedation with propofol compared to midazolam is associated with improved clinical outcomes in ICU, with reduced ICU stay MV time and extubation time.
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