Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic A… (NCT05867472) | Clinical Trial Compass
RecruitingPhase 3
Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents
Canada60 participantsStarted 2023-10-10
Plain-language 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.
Who can participate
Age range1 Month – 18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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)
What they're measuring
1
Participant recruitment
Timeframe: 2 years
Trial details
NCT IDNCT05867472
SponsorSunnybrook Health Sciences Centre
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-05
Contact for this trial
Sunnybrook Research Institute, Program Manager - Centre for Clinical Trials Services
✕. 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)