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

NCT05867472 | Recruiting Phase 3

• 1 other identifier: CTO - 4285
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Intensive Care Units, Pediatric; Anesthetics, Inhalation; Mechanically Ventilated, Critically Ill Children

Outcome Measures

Primary Outcomes (1)

• Participant recruitment

  Accrual and/or identification of challenges in accruing 60 mechanically ventilated participants (age 1 month to 18 years).

  2 years

Secondary Outcomes (4)

• Protocol adherence

  28 days

• Attrition

  3 years

• Safety/adverse event rate

  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

  Study days 1, 2 & 3

Other Outcomes (10)

• Feasibility of collecting delirium scores

  28 days

• Delirium-free Coma-free days

  28 days

• Anti-psychotic drug use

  28 days

Study Arms (2)

Inhaled sedation - volatile anesthetic

EXPERIMENTAL

The ICU patient will receive Isoflurane. Dosage will be modified as per health care team guidance for the best treatment of the participant.

Drug: Isoflurane Inhalant Product

IV sedation - standard of care

NO INTERVENTION

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.

Interventions

Isoflurane Inhalant Product DRUG

Isoflurane will be administered using an inhalation device

Inhaled sedation - volatile anesthetic

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (3)

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

Children's Hospital - London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

The Hospital for Sick Children (SickKids)

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Angela Jerath, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sunnybrook Research Institute, Program Manager - Centre for Clinical Trials Services

CONTACT

416-480-6100; ABOVETrial@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 22, 2023
• Study Start: October 10, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2025-04

Locations

CA (3)