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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-10

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Inhaled sedation - volatile anesthetic

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.

Group Type EXPERIMENTAL

Isoflurane Inhalant Product

Intervention Type DRUG

Isoflurane will be administered using an inhalation device

Sevoflurane inhalant product

Intervention Type DRUG

Sevoflurane will be administered using an inhalation device

IV sedation - standard of care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Isoflurane Inhalant Product

Isoflurane will be administered using an inhalation device

Intervention Type DRUG

Sevoflurane inhalant product

Sevoflurane will be administered using an inhalation device

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No