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:

  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

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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Page 1 of 1 (3 locations)

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