RecruitingPhase 3NCT05867472

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

Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents: A Pilot Multicentre Randomized Controlled Trial


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

60 participants

Start Date

Oct 10, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 MonthMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study — called ABOVE (Advancing Brain Outcomes) — investigates whether using volatile anesthetic gases (like isoflurane or sevoflurane, the type used in operating rooms) for sedation in critically ill children on ventilators leads to better brain outcomes than standard intravenous (IV) sedation. Children in pediatric intensive care often need sedation for days while on a breathing machine, and the drugs used can profoundly affect brain development and recovery. Volatile anesthetics may offer advantages in terms of shorter sedation duration and potentially less delirium. The trial enrolls pediatric patients from 1 month to under 18 years old who need sedation for mechanical ventilation expected to last at least 24 hours. Children with certain genetic muscle diseases (like Duchenne muscular dystrophy), a family or personal history of malignant hyperthermia, known allergy to volatile anesthetics, high intracranial pressure, or who are expected to survive less than 24 hours are excluded. This research matters enormously because PICU-associated brain injury — including delirium, developmental delay, and cognitive problems after discharge — affects thousands of children each year. Finding the safest, most brain-protective sedation method could significantly improve outcomes for some of the most vulnerable pediatric patients.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIsoflurane Inhalant Product

Isoflurane will be administered using an inhalation device


Locations(3)

McMaster Children's Hospital

Hamilton, Ontario, Canada

Children's Hospital - London Health Sciences Centre

London, Ontario, Canada

The Hospital for Sick Children (SickKids)

Toronto, Ontario, Canada

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NCT05867472


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