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Recruiting NCT05867472

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Isoflurane Inhalant Product.
Who it may be relevant to
Registry conditions: Intensive Care Units, Pediatric, Anesthetics, Inhalation, Mechanically Ventilated, Critically Ill Children. Basic parameters: 1 months — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents: A Pilot Multicentre Randomized Controlled Trial

Overview

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.

Interventions

  • Drug Isoflurane Inhalant Product
    Isoflurane will be administered using an inhalation device

Primary outcome measures

  • Participant recruitment [Time frame: 2 years]
Secondary outcome measures (4)
  • Protocol adherence [Time frame: 28 days]
  • Attrition [Time frame: 3 years]
  • Safety/adverse event rate [Time frame: From date of consent until the date of resolution or date of death from any cause, whichever came first, assessed up to 13 months]
  • Healthcare team satisfaction [Time frame: Study days 1, 2 & 3]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 3 centers
  • McMaster Children's Hospital — Hamilton
  • Children's Hospital - London Health Sciences Centre — London
  • The Hospital for Sick Children (SickKids) — Toronto

Identifiers

NCT: NCT05867472 · CTO - 4285

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗