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Inhaled Anesthetic

Volatile Anesthetics for COVID-19 (SAVE-ICU Trial)

Phase 3

Recruiting

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Receiving IV sedation by infusion or bolus for ≤72 hours to facilitate mechanical ventilation

≥ 18 years of age

Must not have

Severe brain injury that is likely to lead to sustained very low conscious levels or vegetative state

Suspect or evidence of high intracranial pressure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing whether using gases to keep patients sedated while on a breathing machine is more effective than using drugs.

Who is the study for?

Adults over 18, on mechanical ventilation for severe lung failure possibly due to COVID-19, and expected to need it for at least another day. They should have been sedated via IV for no more than 72 hours and not allergic to the trial drugs. Excluded are those with high brain pressure, severe brain injury, certain lung or neuromuscular conditions, contraindications to specific sedatives, pregnant women or patients unlikely to survive a day.

What is being tested?

The study compares inhaled anesthetics Sevoflurane and Isoflurane as alternatives for IV sedation in ICU patients with respiratory failure. It aims to see if these gases can improve survival rates, reduce time on ventilators and in hospitals by reducing lung inflammation and improving oxygen levels.

What are the potential side effects?

Potential side effects of Sevoflurane and Isoflurane may include dizziness, coughing, nausea or vomiting after waking up from sedation. Rarely they might cause confusion or agitation upon waking.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on IV sedation for less than 72 hours to help with mechanical breathing.

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I am 18 years old or older.

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I am on strong pain medication through an IV to help with sedation or agitation while on a ventilator.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe brain injury likely to cause prolonged unconsciousness.

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I might have high pressure inside my skull.

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I am not allergic to the ingredients in the study drugs or to sevoflurane/isoflurane.

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I have had surgery to remove one lung or use only one lung for breathing.

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My breathing capacity is too low for certain inhaled treatments.

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I have a severe muscle disorder like ALS or Guillain-Barre Syndrome that required ICU care and a breathing machine.

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I cannot take certain sedatives due to severe reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hospital Mortality

ICU-Free Days

Participant Quality of Life at 3 and 12 months after discharge

+1 more

Secondary study objectives

Adjunctive ARDS therapies

Delirium and Coma Free Days

Disability

+2 more

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Inhaled - volatile anestheticExperimental Treatment2 Interventions

The ICU patient will be randomized to either Isoflurane or Sevoflurane, whichever is available at the hospital. Dosage will be modified as per health care team guidance for the best treatment of the participant.

Group II: Non-randomizedActive Control1 Intervention

In this arm, ICU patients who cannot be randomized will receive inhaled or IV sedation as per available in their unit. This is done to try to obtain the maximum amount of information available from the patients present to our ICUs.

Group III: Standard CareActive Control1 Intervention

The ICU patient will be randomized to standard of care, which is any IV sedation supplied by the hospital. Dosage will be modified as per health care team guidance for the best treatment of the participant.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sevoflurane

FDA approved

0 / 10Eligibility criteria met