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NCT Number: NCT05867472

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

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.

Recruiting

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Key information

Conditions

Intensive Care Units, Pediatric Anesthetics, Inhalation Mechanically Ventilated, Critically Ill Children Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

McMaster Children's Hospital, Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isoflurane Inhalant Product

Drug

Isoflurane will be administered using an inhalation device

Primary outcomes

  1. Participant recruitment

    Time frame: 2 years

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

Secondary outcomes

  1. Protocol adherence

    Time frame: 28 days

    The frequency (%) of randomized patients who remain within their designated trial arm and cross-overs. Cross overs may occur from i) drug allergy (rare <0.1%), ii) clinical reason, iii) equipment issues, and iv) health team discomfort using a new intervention.

  2. Attrition

    Time frame: 3 years

    The frequency (%) of randomized patients who are lost to follow up prior to completion of all study outcome measures and the reasons for no follow-up will be documented. Expected loss to follow-up can occur due to i) inter-facility transfers, ii) patient/family withdrawal from the trial, iii) lack of interest in long-term follow-up.

  3. 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

    Adverse events that are assess as related (possibly, probably or definitely) to study intervention, standard of care, or study equipment will be reported. Adverse events that are assess as unrelated to study intervention, standard of care or study equipment will not be reported. Adverse events will be captured from the time of consent until the time of study completion.

  4. Healthcare team satisfaction

    Time frame: Study days 1, 2 & 3

    All health team members (physicians, nurses and respiratory therapists) will be surveyed daily for up to 3 days in both study arms using a 5-point Likert scale satisfaction score. Free text comments will be allowed to better understand barriers and facilitators.

Other outcomes

  1. Feasibility of collecting delirium scores

    Time frame: 28 days

    Proportion of participants who complete delirium (Cornell Assessment of Pediatric Delirium (CAPD)) and coma (Richmond Agitation Sedation Scale (RASS) or COMFORT Behavioural Scale (COMFORT-B)) assessments twice a day.

  2. Delirium-free Coma-free days

    Time frame: 28 days

    The number of full days participants do not experience coma or delirium as assessed by RASS or COMFORT-B for coma and CAPD for delirium.

  3. Anti-psychotic drug use

    Time frame: 28 days

    The administration of anti-psychotic drugs will be captured from baseline until day 28.

  4. Sedative drug use

    Time frame: 28 days

    The administration of sedative drugs will be captured from baseline until day 28.

  5. Blood collection to assess biological markers of delirium, inflammation and brain injury

    Time frame: Study days 1, 2 & 3

    Participants over >2 years old will be able to participate in an optional blood collection sub-study that will look at 60 markers of delirium, inflammation and brain injury.

  6. Feasibility of neurocognitive assessment

    Time frame: 1-year post enrollment

    Proportion of participants who complete 12 month neurocognitive assessment

  7. Neurocognitive scores

    Time frame: 1-year post enrollment

    Assessment of scores from age-appropriate neurocognitive tests completed at 12-months post enrollment

  8. In-hospital mortality

    Time frame: 1 year

    Participant survival status will be captured daily for 28 days and reported at hospital discharge

  9. Ventilator-free days

    Time frame: 28 days

    The use of a ventilator will be captured from baseline until day 28. The number of days a participant does not require a ventilator will be computed.

  10. ICU-free days

    Time frame: 28 days

    ICU discharge date will be captured and compared to admission date to determine number of days the participant was not in the ICU up to 28 days.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

416-480-6100

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Acronym: ABOVE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 22, 2023
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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