Covid19Phase 3SAVE-ICUNCT04415060

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

A Phase 3 study testing Isoflurane Inhalant Product and Sevoflurane inhalant product in people with Covid19 and Hypoxic Respiratory Failure, run by Sunnybrook Health Sciences Centre at 13 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Covid19, Hypoxic Respiratory Failure
What is being tested?: Isoflurane Inhalant Product and Sevoflurane inhalant product
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 800 participants
Where: 13 sitesCanada
Study dates: 15 Jun 2020to 15 Jun 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥ 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.
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.
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

Who cannot join

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;

Show all 10Show fewer

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

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

Canada13 sites

University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Grey Nuns Community Hospital
Edmonton, Alberta, T6L 5X8
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5
London Health Sciences Centre - Victoria Hospital
London, Ontario
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
McGill University Health Centre - Royal Victoria Hospital
Montreal, Quebec, H4A 3J1
Hôpital Sacré-Coeur de Montréal
Montreal, Quebec, H4J1C5
The Ottawa Hospital
Ottawa, Ontario
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec, Quebec, G1V 4G5
Universite de Sherbrooke
Sherbrooke, Quebec, J1K 2R1
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
University Health Network - Toronto General Hospital
Toronto, Ontario, M5G 2C4
University Health Network - Toronto Western Hopsital
Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

Official title: SedAting With Volatile Anesthetics Critically Ill COVID-19 Patients in ICU: Effects On Ventilatory Parameters And Survival. Multicentre Open-label, Pragmatic, Randomized Controlled Trial and a Parallel Prospective (Non-randomized) Cohort Study

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.

Read the detailed description

Multicentre open-label, pragmatic, randomized controlled trial and a parallel prospective (non-randomized) cohort study conducted in ICUs and ICU enabled environments caring in critically ill COVID-19 and non-COVID hypoxic respiratory failure patients.

Participants will be mechanically ventilated and will be variably randomized, within 72 hours of start of sedation treatment, in a 1:1 ratio to either an intravenous or inhaled volatile-based sedation arm depending on availability of sedative drugs for both arms. Stratification will be done by:

Age ≥ 65 years
participating centre
PaO2/FiO2 ratio of 150

Patients who cannot be randomized (due to technical or resource issues in some areas of the hospital) will be entered into the parallel prospective (non-randomized) cohort study and will receive intravenous or inhaled sedation as able in their designated unit.

Sedation will be administered according to standard sedation practice and in keeping with current guidelines.

Participants will be followed:

daily in ICU until 30 days after enrollment, ICU discharge or death, whichever occurs first;
at 30 days after last dose of drug administration by telephone or through the hospital healthcare database;
at 60 days, 90 days, and 365 days after enrollment by telephone and/or through data linkages with a provincial or hospital or state healthcare database;
Participants will have the option to participate in the neuro-cognitive and / or biomarker assessments

Conditions: Covid19, Hypoxic Respiratory Failure
Being tested: Isoflurane Inhalant Product, Sevoflurane inhalant product
Keywords: sedation, ICU, volatile anesthetics
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Isoflurane Inhalant ProductDrug
Isoflurane will be administered using an inhalation device
Sevoflurane inhalant productDrug
Sevoflurane will be administered using an inhalation device

Study groups in NCT04415060
Study group	Role	What they receive
Inhaled - volatile anesthetic	Experimental	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. Receives: Drug: Isoflurane Inhalant Product; Drug: Sevoflurane inhalant product
Standard Care	No 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.
Non-randomized	No 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 365 days

Secondary outcomes (8)

Ventilator-Free Days
Does the use of inhaled volatile anesthetic-based sedation regimen improve participant ventilation outcomes after 30 days post enrollment, as compared to standard intravenous sedation regimen for 200 participants
Measured: 30 days
ICU-Free Days
Does the use of inhaled volatile anesthetic-based sedation regimen improve participant time spent in ICU, 30 days post enrollment, as compared to standard intravenous sedation regimen for 128 participants
Measured: 30 days
Participant Quality of Life at 3 months after discharge
Does the use of inhaled volatile anesthetic-based sedation regimen improve participant quality of life outcomes at 3 months post discharge as compared to standard intravenous sedation regimen for 144 participants. To evaluate the quality of life, the EuroQol-5 Dimensional (EQ5D) survey will be completed at 90 days.
Measured: 90 days
Delirium and Coma Free Days
To evaluate the days alive and free from delirium and coma while in ICU for 14 days after enrollment
Measured: 14 days
Median Daily Oxygenation
To evaluate participant median daily oxygenation (PaO2/FiO2) at 3 days post enrollment
Measured: 3 days
Adjunctive ARDS therapies
To evaluate participant need for adjunctive ARDS therapies (prone, nitric oxide, paralysis, ECMO) during ICU stay
Measured: 30 days
Hospital-Free Days
To evaluate the number of hospital-free days for participants, 60 days after enrollment
Measured: 60 days
Disability
To evaluate participant disability at 3 and 12 months post discharge. The World Health Organization Disabiltity Assessment Score (WHODAS 2.0) will be completed at both timepoints. The scores assigned to each of the items - "none" (0), "mild" (1) "moderate" (2), "severe" (3) and "extreme" (4) - are summed. This method is referred to as simple scoring because the scores from each of the items are simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items.
Measured: 365 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 202015 Jun 2027

First posted4 Jun 2020
Study start15 Jun 2020
Primary completion31 Mar 2026 (estimated)
Study completion15 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Covid19Studies of the same condition, open and under way.
More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Multicentre open-label, pragmatic, randomized controlled trial and a parallel prospective (non-randomized) cohort study
Masking: None (open label)
Enrolment: 800 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04415060
Sponsor's protocol ID: 2149
Acronym: SAVE-ICU
Status last verified: Jul 2025
First submitted: 2 Jun 2020
Last updated: 9 Feb 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Jerath A, Slessarev M, Martin C, D'Aragon F, Carrier FM, Senaratne J, Meggison H, Hooper J, Cavayas YA, Goligher EC, Couture EJ, Randall IM, Hatzakorzian R, Jacka M, Wiener-Kronish J, Xie Z, Pinto R, Hussain I, Cuthbertson BH; SAVE-ICU Investigators and the Canadian Critical Care Trials Group. Isoflurane-Based Inhaled Sedation in Mechanically Ventilated Adults With Acute Hypoxemic Respiratory Failure: The SAVE-ICU Randomized Clinical Trial. JAMA. 2026 Oct 14. doi: 10.1001/jama.2026.18471. Online ahead of print.
PubMed 42872958
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.
PubMed 41083292

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SedAting With Volatile Anesthetics Critically Ill COVID-19 Patients in ICU: Effects On Ventilatory Parameters And Survival. Multicentre Open-label, Pragmatic, Randomized Controlled Trial and a Parallel Prospective (Non-randomized) Cohort Study
ClinicalTrials.gov ID: NCT04415060
Acronym / sponsor ID: SAVE-ICU / 2149
Conditions: Covid19, Hypoxic Respiratory Failure
Keywords: sedation, ICU, volatile anesthetics
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 800 participants (estimated)
Lead sponsor: Sunnybrook Health Sciences CentreUniversity, hospital or other
Study start: 15 Jun 2020 (actual)
Primary completion: 31 Mar 2026 (estimated)
Study completion: 15 Jun 2027 (estimated)
First posted: 4 Jun 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Age ≥ 65 years
participating centre
PaO2/FiO2 ratio of 150

Sedation will be administered according to standard sedation practice and in keeping with current guidelines.

Participants will be followed:

daily in ICU until 30 days after enrollment, ICU discharge or death, whichever occurs first;
at 30 days after last dose of drug administration by telephone or through the hospital healthcare database;
at 60 days, 90 days, and 365 days after enrollment by telephone and/or through data linkages with a provincial or hospital or state healthcare database;
Participants will have the option to participate in the neuro-cognitive and / or biomarker assessments

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Multicentre open-label, pragmatic, randomized controlled trial and a parallel prospective (non-randomized) cohort study

Arm	Type	Receives
Inhaled - volatile anesthetic	Experimental	Drug: Isoflurane Inhalant Product, Drug: Sevoflurane inhalant productThe 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 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.
Non-randomized	No 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

≥ 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.
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.
Mechanically ventilated patients +/- extracorporeal membrane oxygenation (extracorporeal life) support with:

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Isoflurane Inhalant ProductIsoflurane will be administered using an inhalation device	Drug	Inhaled - volatile anesthetic
Sevoflurane inhalant productSevoflurane will be administered using an inhalation device	Drug	Inhaled - volatile anesthetic

Primary outcome

Hospital Mortality
Time frame: 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.

8 secondary outcomes

Ventilator-Free Days
Time frame: 30 days
ICU-Free Days
Time frame: 30 days
Participant Quality of Life at 3 months after discharge
Time frame: 90 days
Delirium and Coma Free Days
Time frame: 14 days
Median Daily Oxygenation
Time frame: 3 days
Adjunctive ARDS therapies
Time frame: 30 days
Hospital-Free Days
Time frame: 60 days
Disability
Time frame: 365 days

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
Derived from this study: PubMed 42872958Jerath A, Slessarev M, Martin C, D'Aragon F, Carrier FM, Senaratne J, Meggison H, Hooper J, Cavayas YA, Goligher EC, Couture EJ, Randall IM, Hatzakorzian R, Jacka M, Wiener-Kronish J, Xie Z, Pinto R, Hussain I, Cuthbertson BH; SAVE-ICU Investigators and the Canadian Critical Care Trials Group. Isoflurane-Based Inhaled Sedation in Mechanically Ventilated Adults With Acute Hypoxemic Respiratory Failure: The SAVE-ICU Randomized Clinical Trial. JAMA. 2026 Oct 14. doi: 10.1001/jama.2026.18471. Online ahead of print.
Derived from this study: PubMed 41083292Jerath 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital Mortality (time frame: 365 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04415060, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.