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

Sunnybrook Health Sciences Centre

Status and phase: Enrolling; Phase 3

Conditions: Anesthetics, Inhalation; Intensive Care Units, Pediatric

Treatments: Drug: Isoflurane Inhalant Product; Drug: Sevoflurane inhalant product

Study type: Interventional

Funder types: Other

Identifiers

NCT05867472

CTO - 4285

Details and patient eligibility

About

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 1 year.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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. Pregnancy or lactation
7. Suspected or evidence of high intracranial pressure (ICP)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Inhaled sedation - volatile anesthetic

Experimental group

Description:

The ICU patient will receive either Isoflurane or Sevoflurane, whichever is available at the hospital. Dosage will be modified as per health care team guidance for the best treatment of the participant.

Treatment:

Drug: Sevoflurane inhalant product

Drug: Isoflurane Inhalant Product

IV sedation - standard of care

No Intervention group

Description:

The ICU patient will receive standard of care, which is IV sedation supplied by the hospital. Dosage will be modified as per health care team guidance for the best treatment of the participant.