SedAting With Volatile Anesthetics Critically Ill COVID-19 Patients in ICU: Effects On Ventilatory Parameters And Survival
SAVE-ICU
1 other identifier
interventional
800
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 covid19
Started Jun 2020
Longer than P75 for phase_3 covid19
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2020
CompletedFirst Posted
Study publicly available on registry
June 4, 2020
CompletedStudy Start
First participant enrolled
June 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2027
ExpectedFebruary 9, 2026
July 1, 2025
5.8 years
June 2, 2020
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospital Mortality
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.
365 days
Secondary Outcomes (8)
Ventilator-Free Days
30 days
ICU-Free Days
30 days
Participant Quality of Life at 3 months after discharge
90 days
Delirium and Coma Free Days
14 days
Median Daily Oxygenation
3 days
- +3 more secondary outcomes
Study Arms (3)
Inhaled - volatile anesthetic
EXPERIMENTALThe 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.
Standard Care
NO INTERVENTIONThe 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.
Non-randomized
NO INTERVENTIONIn 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.
Interventions
Isoflurane will be administered using an inhalation device
Sevoflurane will be administered using an inhalation device
Eligibility Criteria
You may qualify if:
- ≥ 18 years of age
- Mechanically ventilated and expected to remain mechanically ventilated at the end of the next day
- 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.
- Mechanically ventilated patients +/- extracorporeal membrane oxygenation (extracorporeal life) support with:
- Proven or suspected (under investigation) COVID-19, or
- 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
You may not qualify if:
- Contraindications to sedatives, such as propofol infusion syndrome or malignant hyperthermia;
- Known allergy to any of the ingredients or components of the investigational products; sevoflurane or isoflurane;
- Suspect or evidence of high intracranial pressure;
- Severe brain injury that is likely to lead to sustained very low conscious levels or vegetative state
- Severe neuromuscular disorder for example amyotrophic lateral sclerosis, Gullian Barre Syndrome that are the primary cause of needing ICU admission and mechanical ventilation
- One-lung ventilation or pneumonectomy;
- Ideal estimated tidal volume too low for delivery of inhaled agents. Target (6ml/kg) \< 200ml;
- 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;
- Known pregnancy
- Moribund patient not expected to survive \>12 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Grey Nuns Community Hospital
Edmonton, Alberta, T6L 5X8, Canada
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5, Canada
London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5, Canada
University Health Network - Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
University Health Network - Toronto Western Hopsital
Toronto, Ontario, M5T 2S8, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4, Canada
McGill University Health Centre - Royal Victoria Hospital
Montreal, Quebec, H4A 3J1, Canada
Hôpital Sacré-Coeur de Montréal
Montreal, Quebec, H4J1C5, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec, Quebec, G1V 4G5, Canada
Universite de Sherbrooke
Sherbrooke, Quebec, J1K 2R1, Canada
Related Publications (1)
Jerath A, Slessarev M, Martin C, D'Aragon F, Carrier FM, Senaratne J, Meggison H, Hooper J, Alexandros Cavayas Y, Goligher EC, Couture EJ, Randall I, Hatzakorzian R, Jacka M, Wiener-Kronish J, Xie Z, Pinto RL, Cuthbertson B; SAVE-ICU Investigators and the Canadian Critical Care Trials Group. Sedating with volatile anaesthetics for COVID-19 and non-COVID-19 acute hypoxaemic respiratory failure patients in ICU (SAVE-ICU): protocol for a randomised clinical trial. BMJ Open. 2025 Oct 13;15(10):e108441. doi: 10.1136/bmjopen-2025-108441.
PMID: 41083292DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2020
First Posted
June 4, 2020
Study Start
June 15, 2020
Primary Completion
March 31, 2026
Study Completion (Estimated)
June 15, 2027
Last Updated
February 9, 2026
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share