Recruiting
Phase 3

Volatile Anesthetics

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT05867472

Conditions

Intensive Care Units, Pediatric

Anesthetics, Inhalation

Mechanically Ventilated, Critically Ill Children

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Isoflurane Inhalant Product

Study Details

Brief 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 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.

Conditions

Intensive Care Units, Pediatric

Anesthetics, Inhalation

Mechanically Ventilated, Critically Ill Children

Study ID

NCT05867472

Start date

Oct 10, 2023

Status verified date

Apr, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Inhaled sedation - volatile anesthetic

The ICU patient will receive Isoflurane. Dosage will be modified as per health care team guidance for the best treatment of the participant.

no intervention: IV sedation - standard of care

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.

Interventions

Isoflurane Inhalant Product

Isoflurane will be administered using an inhalation device

Primary outcome measure

  • Participant recruitment [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Sunnybrook Research Institute, Program Manager - Centre for Clinical Trials Services

416-480-6100ABOVETrial@sunnybrook.ca

Locations

McMaster Children's Hospital

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contacts

Principal Investigator:

Marina Mir-Parramon, MD

Children's Hospital - London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Principal Investigator:

Rishi Ganesan, MD, DM

The Hospital for Sick Children (SickKids)

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Principal Investigator:

Nicole McKinnon, MD, PhD

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Feb 4, 2026

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2026-02-04.