Could inhaled gases help COVID-19 patients breathe easier and survive?
NCT ID NCT04415060
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether giving inhaled anesthetics (isoflurane or sevoflurane) to sedate COVID-19 patients on ventilators can improve survival and reduce time on the breathing machine compared to standard IV sedatives. About 800 adults in the ICU with lung failure will be randomly assigned to receive either inhaled or IV sedation. The goal is to see if the inhaled approach leads to better outcomes and eases pressure on limited drug supplies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Isoflurane or Sevoflurane (inhaled anesthetics)
- What this could lead to
- If it works, this could provide a widely available alternative to IV sedatives, potentially improving survival and freeing up ventilators faster.
- What could go wrong
- This is an early-stage phase 3 trial with 800 participants, and results may not show a clear benefit. Inhaled anesthetics can have side effects like low blood pressure or breathing issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 800 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2020
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. ≥ 18 years of age 2. Mechanically ventilated and expected to remain mechanically ventilated at the end of the next day 3. Receiving IV sedation by infusion or bolus for ≤72 hours to facilitate mechanical ventilation Transferred patients with escalating ventilation needs are eligible for recruitment within ≤72 hours of sedation commenced within the participating trial site that they were transferred to. Note: Intravenous sedation required to support mechanical ventilation includes use of one or more of the following agents: benzodiazepines, propofol, ketamine, barbiturates, alpha-2 agonist, opioids. Patients receiving intravenous opioids only i.e., fentanyl ≥ 50mcg/hour, hydromorphone ≥ 0.4mg/hour (or bolus q1h) for analgesia and sedation or agitation to assist mechanical ventilation are eligible for inclusion. 4. Mechanically ventilated patients +/- extracorporeal membrane oxygenation (extracorporeal life) support with: 1. Proven or suspected (under investigation) COVID-19, or 2. COVID-19 negative patients who have a PaO2FiO2 ratio ≤300 measured with arterial blood gas at least once during the 12 hours prior to enrollment. Note: If arterial blood gas measurement is unavailable, the PaO2 can be imputed from the pulse oximetry measurement Exclusion Criteria: 1. Contraindications to sedatives, such as propofol infusion syndrome or malignant hyperthermia; 2. Known allergy to any of the ingredients or components of the investigational products; sevoflurane or isoflurane; 3. Suspect or evidence of high intracranial pressure; 4. Severe brain injury that is likely to lead to sustained very low conscious levels or vegetative state 5. Severe neuromuscular disorder for example amyotrophic lateral sclerosis, Gullian Barre Syndrome that are the primary cause of needing ICU admission and mechanical ventilation 6. One-lung ventilation or pneumonectomy; 7. Ideal estimated tidal volume too low for delivery of inhaled agents. Target (6ml/kg) \< 200ml; 8. Use of inhaled prostacyclin which is contraindicated in the presence of a miniature vaporizer (i.e., Anesthesia Conserving Device). This agent has a high viscosity that leads to poor vaporization of the volatile agent. Note: Other inhaled pulmonary vasodilators such as nitric oxide can be safely administered in the presence of miniature vaporizers. Use of prostacyclin is permissible with an anesthesia machine and MADM; 9. Known pregnancy 10. Moribund patient not expected to survive \>12 hours
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4, Canada
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Grey Nuns Community Hospital
Edmonton, Alberta, T6L 5X8, Canada
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Hôpital Sacré-Coeur de Montréal
Montreal, Quebec, H4J1C5, Canada
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Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec, Quebec, G1V 4G5, Canada
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London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5, Canada
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London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada
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McGill University Health Centre - Royal Victoria Hospital
Montreal, Quebec, H4A 3J1, Canada
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Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5, Canada
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The Ottawa Hospital
Ottawa, Ontario, Canada
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Universite de Sherbrooke
Sherbrooke, Quebec, J1K 2R1, Canada
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University Health Network - Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
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University Health Network - Toronto Western Hopsital
Toronto, Ontario, M5T 2S8, Canada
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University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
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