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

Recruiting now · Phase 3

Conditions studied: Intensive Care Units, Pediatric, Anesthetics, Inhalation, Mechanically Ventilated, Critically Ill Children

In brief

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.

Key facts

Study ID

NCT05867472

Run by

Sunnybrook Health Sciences Centre

People needed

60

Starts

2023-10-10

Expected to finish

2026-12-01

Last updated by the study team

2026-02-04

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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
• 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

Where it is running

• McMaster Children's Hospital — Hamilton, Ontario, Canada (enrolling)
• Children's Hospital - London Health Sciences Centre — London, Ontario, Canada (enrolling)
• The Hospital for Sick Children (SickKids) — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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