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Could a gas calm kids on ventilators and cut delirium?

NCT ID NCT05867472

Symptom relief Sponsor: Sunnybrook Health Sciences Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests whether using inhaled sedatives (like isoflurane gas) instead of standard IV sedatives can reduce delirium—extreme confusion—in children who need a breathing machine. The study will enroll 60 children aged 1 month to 18 years in intensive care. The main goal is to see if families and healthcare teams accept the study plan, not yet to prove the treatment works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Isoflurane (inhaled sedative)
What this could lead to
If this pilot shows the study plan works, it could lead to a larger trial testing whether inhaled sedatives reduce delirium and improve brain outcomes in critically ill children.
What could go wrong
This is a small pilot study (60 participants) focused on feasibility, not on proving the treatment works. The results may not apply to all children, and there are risks like drug allergy or equipment 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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

1 month to 18 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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 2. Receiving IV sedation by infusion or bolus for ≤72h to aid mechanical ventilation (but will be recruited as early as possible) Exclusion Criteria: 1. Current use of inhaled prostacyclin (high viscosity of prostacyclin impairs vaporizer device) or continuous salbutamol nebulization (impairs gas analyzer function) 2. Family history or personal history of malignant hyperthermia (MH) 3. Allergy to isoflurane, sevoflurane or other volatile inhaled anesthetic gas 4. Metabolic, mitochondrial or myopathy disease e.g., Duchenne muscular dystrophy (volatiles may trigger malignant hyperthermia like reaction) 5. Moribund with expected survival \< 24h 6. Known pregnancy or lactation 7. Suspected or evidence of high intracranial pressure (ICP) 8. 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) 9. Prior enrollment in the ABOVE trial

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Conditions

The condition(s) this trial relates to.

Respiratory Aspiration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anesthetics, inhalation Intensive care units, pediatric Mechanically ventilated, critically ill children

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Children's Hospital - London Health Sciences Centre

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • McMaster Children's Hospital

    RECRUITING

    Hamilton, Ontario, L8N 3Z5, Canada

  • The Hospital for Sick Children (SickKids)

    RECRUITING

    Toronto, Ontario, M5G 1X8, Canada

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