Inhaled Isoflurane vs. IV Propofol for ICU Sedation

(INSPiRE-ICU1 Trial)

Recruiting at 13 trial locations

Overseen By Magnus Falkenhav, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sedana Medical

Must not be taking: Benzodiazepines, Barbiturates

Disqualifiers: Neurological condition, Hemodynamic compromise, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 48 (±6) hours

235 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drugs Isoflurane and Propofol for ICU sedation?

Research shows that both Isoflurane and Propofol are effective for sedation in ICU patients, with studies indicating that Isoflurane can be a useful alternative to Propofol. Both drugs have been shown to provide optimal sedation with few adverse events, and Isoflurane may offer better control of sedation compared to Propofol. ^{1 2 3 4 5}

Is inhaled isoflurane safe for ICU sedation compared to IV propofol?

Inhaled isoflurane and IV propofol are both considered safe for ICU sedation, with few adverse events reported. Isoflurane may have additional benefits like reducing time on ventilators and less impact on the liver and kidneys, but it requires specific equipment and training. Rarely, it can cause a serious condition called malignant hyperthermia, which needs immediate treatment. ^{1 2 3 4 6}

How does inhaled isoflurane differ from IV propofol for ICU sedation?

Inhaled isoflurane is unique because it is administered through the lungs using special equipment, which may reduce side effects and improve outcomes compared to the traditional intravenous (IV) method used for propofol. This approach allows for more precise control of sedation levels and may offer additional benefits for ICU patients. ^{1 2 3 4 7}

Research Team

Kimberly Rengel, M.D.

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

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 am on constant sedation due to my medical condition.

Exclusion Criteria

Ventilator tidal volume <200 or >1000 mL at Baseline

I am allergic or cannot take propofol or isoflurane.

I am receiving care focused on comfort, not curing my illness.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either inhaled isoflurane via Sedaconda ACD-S or intravenous propofol for sedation while mechanically ventilated in the ICU

Up to 48 (±6) hours

Continuous monitoring in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment, including mortality and cognitive recovery assessments

6 months

Long-term follow-up

Participants' mortality and other outcomes are assessed at 3 and 6 months post-randomization

6 months

Treatment Details

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.

Participant Groups

Group I: Isoflurane Experimental Treatment 1 Intervention

Inhaled isoflurane administered via Sedaconda ACD-S

Group II: Propofol Active Control 1 Intervention

Propofol administered as intravenous infusion

Who Is Running the Clinical Trial?

Sedana Medical

Lead Sponsor

Trials

5

Recruited

900+

Findings from Research

Inhaled sedation using agents like isoflurane and sevoflurane is now possible in ICU settings, offering a well-tolerated and adjustable sedation option for patients, provided that proper equipment and training are available.

These inhaled agents not only serve as effective sedatives but may also offer additional clinical benefits for ICU patients, suggesting a promising alternative to traditional intravenous sedation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhaled sedation in the intensive care unit. Jabaudon, M., Zhai, R., Blondonnet, R., et al.[2022]

References

1. France pubmed.ncbi.nlm.nih.gov

Inhaled sedation in the intensive care unit. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Isoflurane and propofol for long-term sedation in the intensive care unit. A crossover study. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Survival after long-term isoflurane sedation as opposed to intravenous sedation in critically ill surgical patients: Retrospective analysis. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Inhaled isoflurane via the anaesthetic conserving device versus propofol for sedation of invasively ventilated patients in intensive care units in Germany and Slovenia: an open-label, phase 3, randomised controlled, non-inferiority trial. [2022]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Sedation in PACU: the role of propofol. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Inhaled Sedation with Volatile Anesthetics for Mechanically Ventilated Patients in Intensive Care Units: A Narrative Review. [2023]

7. India pubmed.ncbi.nlm.nih.gov

The advantages of inhalational sedation using an anesthetic-conserving device versus intravenous sedatives in an intensive care unit setting: A systematic review. [2023]