Status:
RECRUITING
Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Intensive Care Units, Pediatric
Anesthetics, Inhalation
Eligibility:
All Genders
1-18 years
Phase:
PHASE3
Brief 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 ca...
Eligibility Criteria
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)
- 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
Key Trial Info
Start Date :
October 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05867472
Start Date
October 10 2023
End Date
December 1 2026
Last Update
February 4 2026
Active Locations (3)
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1
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8N 3Z5
2
Children's Hospital - London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
3
The Hospital for Sick Children (SickKids)
Toronto, Ontario, Canada, M5G 1X8