Actively Recruiting

Phase 3
Age: 1Month - 18Years
All Genders
NCT05867472

Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents

Led by Sunnybrook Health Sciences Centre · Updated on 2026-02-04

60

Participants Needed

3

Research Sites

164 weeks

Total Duration

On this page

Sponsors

S

Sunnybrook Health Sciences Centre

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents

Who Can Participate

Age: 1Month - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pediatric patients age from 1 month to less than 18 years who need sedation to tolerate mechanical ventilation and will remain ventilated for 64 hours
  • Receiving intravenous sedation by infusion or bolus for 6472 hours to aid mechanical ventilation (but will be recruited as early as possible)
Not Eligible

You will not qualify if you...

  • Current use of inhaled prostacyclin or continuous salbutamol nebulization
  • Family or personal history of malignant hyperthermia
  • Allergy to isoflurane, sevoflurane, or other volatile inhaled anesthetic gases
  • Metabolic, mitochondrial, or myopathy diseases such as Duchenne muscular dystrophy
  • Moribund with expected survival less than 24 hours
  • Known pregnancy or lactation
  • Suspected or evidence of high intracranial pressure
  • Not using a closed ventilator circuit with potential gas leak
  • Prior enrollment in this trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

McMaster Children's Hospital

Hamilton, Ontario, Canada, L8N 3Z5

Actively Recruiting

2

Children's Hospital - London Health Sciences Centre

London, Ontario, Canada, N6A 5W9

Actively Recruiting

3

The Hospital for Sick Children (SickKids)

Toronto, Ontario, Canada, M5G 1X8

Actively Recruiting

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Research Team

S

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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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