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

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

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

Inclusion Criteria2

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)

Exclusion Criteria9

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

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