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Volatile Anesthetics for COVID-19 (SAVE-ICU Trial)
SAVE-ICU Trial Summary
This trial is testing whether using gases to keep patients sedated while on a breathing machine is more effective than using drugs.
SAVE-ICU Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSAVE-ICU Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SAVE-ICU Trial Design
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Who is running the clinical trial?
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- You are currently using a breathing machine and will still need it tomorrow.I am on IV sedation for less than 72 hours to help with mechanical breathing.I have a severe brain injury likely to cause prolonged unconsciousness.I might have high pressure inside my skull.I was moved to a trial site and needed more help with breathing within the last 3 days.I am not using inhaled prostacyclin with a miniature vaporizer.I have or might have COVID-19, or I am COVID-19 negative but have a low oxygen level.I am 18 years old or older.I am on strong pain medication through an IV to help with sedation or agitation while on a ventilator.I am not allergic to the ingredients in the study drugs or to sevoflurane/isoflurane.I have had surgery to remove one lung or use only one lung for breathing.My breathing capacity is too low for certain inhaled treatments.I have a severe muscle disorder like ALS or Guillain-Barre Syndrome that required ICU care and a breathing machine.I cannot take certain sedatives due to severe reactions.You are very sick and not expected to live longer than 12 hours.
- Group 1: Non-randomized
- Group 2: Inhaled - volatile anesthetic
- Group 3: Standard Care
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are recruitment efforts for this experiment ongoing at present?
"The information available on clinicaltrials.gov suggests that this study is still recruiting patients. The trial was first posted on June 15th, 2020 and has had one update on April 9th, 2021."
Can you give me a breakdown of where this research is taking place?
"This clinical trial has 12 enrolling patients at locations such as Universite de Sherbrooke in Sherbrooke, University of Alberta Hospital in Edmonton, and University Health Network - Toronto Western Hopsital in Toronto."
Are there any other scientific papers that mention Isoflurane Inhalant Product?
"There are currently 43 separate studies underway that focus on Isoflurane Inhalant Product. Out of those, 9 are in Phase 3 clinical trials. The majority of research is based out of Seoul, but there are also 202 other locations running similar tests and investigations."
Has the Isoflurane Inhalant Product received FDA approval?
"Isoflurane Inhalant Product is backed by Phase 3 trial data, meaning that there are both efficacy and safety data supporting its use. Therefore, it received a score of 3 from our team at Power."
How many research subjects are involved in this clinical trial?
"That is correct, the clinicaltrials.gov website does show that this trial is looking for more participants. The study was originally posted on June 15th 2020 and received its last update on April 9th 2021. In total, 752 individuals are needed across 12 different enrolment locations."
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