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NCT05867472 | RECRUITING | Intensive Care Units, Pediatric

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

Sunnybrook Health Sciences Centre

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 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.

Condition or disease

Intensive Care Units, Pediatric

Anesthetics, Inhalation

Mechanically Ventilated, Critically Ill Children

Intervention/treatment

Isoflurane Inhalant Product

Sevoflurane inhalant product

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : SINGLE
Masking Description : This is an open label trial that will be blinded to the outcome assessor and data analyst, but not to the clinical team. Blinding is not feasible for the clinical team and patient / family given the easily identifiable differences in the nature of the essential equipment used between the two arms.
Primary Purpose : TREATMENT
Official Title : Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents: A Pilot Multicentre Randomized Controlled Trial
Actual Study Start Date : 2023-10-10
Estimated Primary Completion Date : 2026-05
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 1 Month to 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
  • 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)
Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents

Location Details

NCT05867472

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Canada, Ontario

McMaster Children's Hospital

Hamilton, Ontario, Canada, Live Binging

RECRUITING

Canada, Ontario

Children's Hospital - London Health Sciences Centre

London, Ontario, Canada, Wicker

RECRUITING

Canada, Ontario

The Hospital for Sick Children (SickKids)

Toronto, Ontario, Canada, M5G 1X8