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

RecruitingPhase 3Ages 1 Month - 18 YearsAllSunnybrook Health Sciences Centre
NCT05867472 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Isoflurane Inhalant Product
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Where

3 sites
McMaster Children's Hospital
Hamilton, Canada
Children's Hospital - London Health Sciences Centre
London, Canada
The Hospital for Sick Children (SickKids)
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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