Clinical trial NCT05867472: Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents
Official title: Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents: A Pilot Multicentre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Intensive Care Units, Pediatric
Anesthetics, Inhalation
Mechanically Ventilated, Critically Ill Children
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot, multicenter, vanguard randomized controlled trial (RCT) to assess the feasibility of accruing patients, delivering the intervention of inhaled sedatives, and ascertaining outcomes in preparation for a definitive trial to evaluate if inhaled sedatives (intervention) compared to IV agents (comparator) improves delirium (outcome) in mechanically ventilated children (population).
Primary purpose: TREATMENT

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.


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)
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)

Primary outcomes:
measure: Participant recruitment
timeFrame: 2 years
Secondary outcomes:
measure: Protocol adherence
timeFrame: 28 days
measure: Attrition
timeFrame: 3 years
measure: Safety/adverse event rate
timeFrame: From date of consent until the date of resolution or date of death from any cause, whichever came first, assessed up to 13 months
measure: Healthcare team satisfaction
timeFrame: Study days 1, 2 & 3
Other outcomes:
measure: Feasibility of collecting delirium scores
timeFrame: 28 days
measure: Delirium-free Coma-free days
timeFrame: 28 days
measure: Anti-psychotic drug use
timeFrame: 28 days
measure: Sedative drug use
timeFrame: 28 days
measure: Blood collection to assess biological markers of delirium, inflammation and brain injury
timeFrame: Study days 1, 2 & 3
measure: Feasibility of neurocognitive assessment
timeFrame: 1-year post enrollment
measure: Neurocognitive scores
timeFrame: 1-year post enrollment
measure: In-hospital mortality
timeFrame: 1 year
measure: Ventilator-free days
timeFrame: 28 days
measure: ICU-free days
timeFrame: 28 days
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: London
country: Canada
facility: Children's Hospital - London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children (SickKids)
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Angela Jerath, MD
role: PRINCIPAL_INVESTIGATOR
References: