Intensive Care Units, PediatricPhase 3ABOVENCT05867472
Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents
A Phase 3 study testing Isoflurane Inhalant Product in people with Intensive Care Units, Pediatric and Anesthetics, Inhalation, run by Sunnybrook Health Sciences Centre at 3 sites in Canada.
Trial summary
The goal of a pilot study is to test a study plan to see if it is appropriate for a larger study. This study plan is looking at whether the use of inhaled sedatives (medications that help people be calm and sleep) can reduce delirium (extreme confusion) in children who need a ventilator (breathing machine) compared to… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Intensive Care Units, Pediatric, Anesthetics, Inhalation, Mechanically Ventilated, Critically Ill Children
- What is being tested?
- Isoflurane Inhalant Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesCanada
- Study dates
- 10 Oct 2023to Dec 2026
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients age from 1 month to less than 18 years who need sedation to tolerate mechanical ventilation and will remain ventilated for ≥ 24 hours
- Receiving IV sedation by infusion or bolus for ≤72h to aid mechanical ventilation (but will be recruited as early as possible)
Who cannot join
- Current use of inhaled prostacyclin (high viscosity of prostacyclin impairs vaporizer device) or continuous salbutamol nebulization (impairs gas analyzer function)
- Family history or personal history of malignant hyperthermia (MH)
- Allergy to isoflurane, sevoflurane or other volatile inhaled anesthetic gas
- Metabolic, mitochondrial or myopathy disease e.g., Duchenne muscular dystrophy (volatiles may trigger malignant hyperthermia like reaction)
- Moribund with expected survival < 24h
- Known pregnancy or lactation
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- Suspected or evidence of high intracranial pressure (ICP)
- Not a 'closed ventilator circuit' with potential for gas leak (e.g. uncuffed ETT, bronchopleural fistula, tracheal/trachea-esophageal fistulas, or other sources of "gas leak" from patient circuit that cannot be removed)
- Prior enrollment in the ABOVE trial
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sunnybrook Research Institute, Program Manager - Centre for Clinical Trials Services contact
Canada3 sites, 3 recruiting
- Recruiting
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5
Sherrie Orr, 905-521-2100 ext. 75824, orrs@mcmaster.ca
Marina Mir-Parramon, mirparrm@mcmaster.ca
- Recruiting
Children's Hospital - London Health Sciences Centre
London, Ontario, N6A 5W9
Maysaa Assaf, 519-685-8500 ext. 77548, Maysaa.Assaf@lhsc.on.ca
Rishi Ganesan, Rishi.Ganesan@lhsc.on.ca
- Recruiting
The Hospital for Sick Children (SickKids)
Toronto, Ontario, M5G 1X8
Stephanie DeLorenzo, 416-813-7654 ext. 414712, stephanie.delorenzo@sickkids.ca
Nicole McKinnon, nicole.mckinnon@sickkids.ca
About this study
Official title: Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents: A Pilot Multicentre Randomized Controlled Trial
The goal of a pilot study is to test a study plan to see if it is appropriate for a larger study. This study plan is looking at whether the use of inhaled sedatives (medications that help people be calm and sleep) can reduce delirium (extreme confusion) in children who need a ventilator (breathing machine) compared to IV or oral sedatives.
The main question[s] it aims to answer are:
Read more
- Will people join the study? (recruitment)
- Will participants finish the study?
- Will healthcare teams accept the study procedures?
Participants will be randomized to receive study treatment (inhaled sedation) or standard of care (IV sedation). They will be monitored daily for up to 28 days. They will complete memory, thinking and behaviour tasks after 9-12 months.
- Conditions
- Intensive Care Units, Pediatric, Anesthetics, Inhalation, Mechanically Ventilated, Critically Ill Children
- Being tested
- Isoflurane Inhalant Product
- Medical subject headings
- Respiratory Aspiration
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
| Study group | Role | What they receive |
|---|---|---|
| Inhaled sedation - volatile anesthetic | Experimental | The ICU patient will receive Isoflurane. Dosage will be modified as per health care team guidance for the best treatment of the participant. Receives: Drug: Isoflurane Inhalant Product |
| IV sedation - standard of care | No intervention | The ICU patient will receive standard of care, which is IV sedation supplied by the hospital. Dosage will be modified as per health care team guidance for the best treatment of the participant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant recruitment
Accrual and/or identification of challenges in accruing 60 mechanically ventilated participants (age 1 month to 18 years).
Measured: 2 years
Secondary outcomes (4)
Protocol adherence
The frequency (%) of randomized patients who remain within their designated trial arm and cross-overs. Cross overs may occur from i) drug allergy (rare <0.1%), ii) clinical reason, iii) equipment issues, and iv) health team discomfort using a new intervention.
Measured: 28 days
Attrition
The frequency (%) of randomized patients who are lost to follow up prior to completion of all study outcome measures and the reasons for no follow-up will be documented. Expected loss to follow-up can occur due to i) inter-facility transfers, ii) patient/family withdrawal from the trial, iii) lack of interest in long-term follow-up.
Measured: 3 years
Safety/adverse event rate
Adverse events that are assess as related (possibly, probably or definitely) to study intervention, standard of care, or study equipment will be reported. Adverse events that are assess as unrelated to study intervention, standard of care or study equipment will not be reported. Adverse events will be captured from the time of consent until the time of study completion.
Measured: From date of consent until the date of resolution or date of death from any cause, whichever came first, assessed up to 13 months
Healthcare team satisfaction
All health team members (physicians, nurses and respiratory therapists) will be surveyed daily for up to 3 days in both study arms using a 5-point Likert scale satisfaction score. Free text comments will be allowed to better understand barriers and facilitators.
Measured: Study days 1, 2 & 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start10 Oct 2023
- Primary completionMay 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Units, PediatricStudies 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
- Pilot, multicenter, vanguard randomized controlled trial (RCT) to assess the feasibility of accruing patients, delivering the intervention of inhaled sedatives, and ascertaining outcomes in preparation for a definitive trial to evaluate if inhaled sedatives (intervention) compared to IV agents (comparator) improves delirium (outcome) in mechanically ventilated children (population).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Angela Jerath, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867472
- Sponsor's protocol ID
- CTO - 4285
- Acronym
- ABOVE
- Status last verified
- Apr 2025
- First submitted
- 2 May 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents: A Pilot Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05867472
- Acronym / sponsor ID
- ABOVE / CTO - 4285
- Conditions
- Intensive Care Units, Pediatric, Anesthetics, Inhalation, Mechanically Ventilated, Critically Ill Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 May 2023 (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.
The goal of a pilot study is to test a study plan to see if it is appropriate for a larger study. This study plan is looking at whether the use of inhaled sedatives (medications that help people be calm and sleep) can reduce delirium (extreme confusion) in children who need a ventilator (breathing machine) compared to IV or oral sedatives.
The main question[s] it aims to answer are:
- Will people join the study? (recruitment)
- Will participants finish the study?
- Will healthcare teams accept the study procedures?
Participants will be randomized to receive study treatment (inhaled sedation) or standard of care (IV sedation). They will be monitored daily for up to 28 days. They will complete memory, thinking and behaviour tasks after 9-12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot, multicenter, vanguard randomized controlled trial (RCT) to assess the feasibility of accruing patients, delivering the intervention of inhaled sedatives, and ascertaining outcomes in preparation for a definitive trial to evaluate if inhaled sedatives (intervention) compared to IV agents (comparator) improves delirium (outcome) in mechanically ventilated children (population).
| Arm | Type | Receives |
|---|---|---|
| Inhaled sedation - volatile anesthetic | Experimental | Drug: Isoflurane Inhalant ProductThe ICU patient will receive Isoflurane. Dosage will be modified as per health care team guidance for the best treatment of the participant. |
| IV sedation - standard of care | No intervention | –The ICU patient will receive standard of care, which is IV sedation supplied by the hospital. Dosage will be modified as per health care team guidance for the best treatment of the participant. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Pediatric patients age from 1 month to less than 18 years who need sedation to tolerate mechanical ventilation and will remain ventilated for ≥ 24 hours
- Receiving IV sedation by infusion or bolus for ≤72h to aid mechanical ventilation (but will be recruited as early as possible)
Key exclusion criteria (9 listed)
- Current use of inhaled prostacyclin (high viscosity of prostacyclin impairs vaporizer device) or continuous salbutamol nebulization (impairs gas analyzer function)
- Family history or personal history of malignant hyperthermia (MH)
- Allergy to isoflurane, sevoflurane or other volatile inhaled anesthetic gas
- Metabolic, mitochondrial or myopathy disease e.g., Duchenne muscular dystrophy (volatiles may trigger malignant hyperthermia like reaction)
- Moribund with expected survival < 24h
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 sedation - volatile anesthetic |
Primary outcome
Participant recruitment
Time frame: 2 years
Accrual and/or identification of challenges in accruing 60 mechanically ventilated participants (age 1 month to 18 years).
4 secondary outcomes
Protocol adherence
Time frame: 28 days
Attrition
Time frame: 3 years
Safety/adverse event rate
Time frame: From date of consent until the date of resolution or date of death from any cause, whichever came first, assessed up to 13 months
Healthcare team satisfaction
Time frame: Study days 1, 2 & 3
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 4 Feb 2026.
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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.
Sunnybrook Research Institute, Program Manager - Centre for Clinical Trials Services contact
Angela Jerath, MD principal investigator
Sunnybrook Health Sciences Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Isoflurane Inhalant Product in people with Intensive Care Units, Pediatric and Anesthetics, Inhalation, run by Sunnybrook Health Sciences Centre at 3 sites in Canada.
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 2 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 4 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 3 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?
Contact Sunnybrook Research Institute, Program Manager - Centre for Clinical Trials Services (416-480-6100, ABOVETrial@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant recruitment (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2026.