SedAting With Volatile Anesthetics Critically Ill COVID-19 Patients in ICU: Effects On Ventilatory Parameters And Survival

NCT04415060 · tracked via the Priya Life Science Canada tracker

Sponsor

Sunnybrook Health Sciences Centre

Phase

Phase 3

Started

2020-06-15

Last updated

2026-02-09

Condition(s) studied

Covid19Hypoxic Respiratory Failure

Investigational drug(s) / intervention(s)

Isoflurane Inhalant Product →Sevoflurane inhalant product

Isoflurane Inhalant Product: Isoflurane will be administered using an inhalation device

Sevoflurane inhalant product: Sevoflurane will be administered using an inhalation device

Study summary

Patients suffering lung failure, possibly from COVID-19 or hypoxic lung failure, will need life-saving support from a breathing machine. Any patient needing this support requires drugs to keep them sleepy, or "sedated" to be comfortable on this machine. Sedation is made possible by using drugs given through a vein. Unfortunately, these drugs are in short supply worldwide due to the high number of COVID-19 patients needing these machines.

Another way to provide sleep is by using gases that are breathed in. These are used every day in operating rooms to perform surgery. These gases, also called "inhaled agents" can also be used in intensive care units and may have several important benefits for patients and the hospital. Research shows they may reduce swelling in the lung and increase oxygen levels, which allows patients to recover faster and reduce the time spent on a breathing machine. In turn, this allows the breathing machine to be used again for the next sick patient. These drugs may also increase the number of patients who live through their illness. Inhaled agents are widely available and their use could dramatically lesson the pressure on limited drug supplies.

This research is a study being carried out in a number of hospitals that will compare how well patients recover from these illnesses depending on which type of sedation drug they receive. The plan is to evaluate the number who survive, their time spent on a breathing machine and time in the hospital. This study may show immediate benefits and may provide a cost effective and practical solution to the current challenges caring for patients and the hospital space, equipment and drugs to the greatest benefit. Furthermore, the study will be investigating inflammatory profile and neuro-cognitive profiles in ventilated patients. Finally, this trial will be a team of experts in sedation drugs who care for patients with proven or suspected COVID-19 who need lifesaving treatments.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Hospital Mortality — 365 days
Does the use of inhaled volatile anesthetic-based sedation regimen improve participant hospital mortality as compared to standard intravenous sedation regimen with a 10% difference between groups for 758 participants.

Trial sites (13)

Facility	City	Region
University of Alberta Hospital	Edmonton	Alberta
Grey Nuns Community Hospital	Edmonton	Alberta
London Health Sciences Centre - University Hospital	London	Ontario
London Health Sciences Centre - Victoria Hospital	London	Ontario
The Ottawa Hospital	Ottawa	Ontario
Sunnybrook Health Sciences Centre	Toronto	Ontario
University Health Network - Toronto General Hospital	Toronto	Ontario
University Health Network - Toronto Western Hopsital	Toronto	Ontario
Centre Hospitalier de l'Université de Montréal	Montreal	Quebec
McGill University Health Centre - Royal Victoria Hospital	Montreal	Quebec
Hôpital Sacré-Coeur de Montréal	Montreal	Quebec
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)	Québec	Quebec
Universite de Sherbrooke	Sherbrooke	Quebec

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Other trials for the same condition

Institut de Recherche Cliniques de Montreal (IRCM) Post-COVID-19 (IPCO) Research Clinic Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04415060 on ClinicalTrials.gov ↗ ← All trials in Canada