← Back to Search

Volatile Anesthetic

Inhaled Sedation for Delirium in Critically Ill Children (ABOVE Trial)

Phase 3

Recruiting

Led By Angela Jerath, MD

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Receiving IV sedation by infusion or bolus for ≤72h to aid mechanical ventilation (but will be recruited as early as possible).

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

ABOVE Trial Summary

This trial will test if inhaled sedation can reduce delirium in ventilated children compared to traditional IV or oral sedation.

Who is the study for?

This trial is for children aged 1 month to less than 18 years who need sedation for mechanical ventilation. They should be on IV sedation for no more than 72 hours and expected to remain ventilated for at least a day. It's not suitable for kids with certain metabolic diseases, high brain pressure, or allergies to inhaled anesthetics.Check my eligibility

What is being tested?

The study tests if inhaled sedatives like Isoflurane or Sevoflurane can better prevent confusion (delirium) compared to standard IV sedatives in critically ill children needing ventilators. The trial will randomly assign participants to either the new approach or standard care and monitor them up to one year.See study design

What are the potential side effects?

Inhaled anesthetics may cause side effects such as nausea, vomiting, throat irritation, and rarely malignant hyperthermia—a severe reaction with a rapid rise in body temperature and muscle contractions.

ABOVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am on IV sedation to help with mechanical breathing for less than 72 hours.

Select...

I am under 18, need sedation for ventilation, and will be ventilated for over 24 hours.

ABOVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Participant recruitment

Secondary outcome measures

Attrition

Healthcare team satisfaction

Protocol adherence

+1 more

Other outcome measures

Anti-psychotic drug use

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

Delirium-free Coma-free days

+7 more

ABOVE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Inhaled sedation - volatile anestheticExperimental Treatment2 Interventions

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 II: IV sedation - standard of careActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sevoflurane inhalant product

2021

Completed Phase 4

~170

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,551,248 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,454 Total Patients Enrolled

Angela Jerath, MDPrincipal InvestigatorSunnybrook Health Sciences Centre

1 Previous Clinical Trials

60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the clinical trial admit participants who are younger than 25 years of age?

"The age range for enrolment into this medical trial is one month to 18 years."

Answered by AI

Are there any open slots for participants in this experiment?

"As per the details shared on clinicaltrials.gov, this research endeavour is actively looking to enrol participants. It was initially posted on October 10th 2023 and recently updated on October 31st 2023."

Answered by AI

What possible side effects should patients be aware of with regards to Inhaled sedation - volatile anesthetic?

"Our team at Power estimated that the safety of inhaled sedation - volatile anesthetic is a 3 due to pre-existing data attesting to its efficacy and multiple studies demonstrating its security."

Answered by AI

To what extent is the clinical trial open to participants?

"Affirmative. According to the details posted on clinicaltrials.gov, this research project is actively recruiting participants having first been listed October 10th 2023 and last updated towards the end of that same month. 60 volunteers are required between two distinct medical facilities."

Answered by AI

Are there any opportunities for me to become involved in the research trial?

"This trial is looking for 60 enrollees with a pediatric intensive care unit aged between 1 month and 18 years. In order to qualify, patients must meet the following prerequisites: children from infancy up to their eighteenth year of life who require sedation while on mechanical ventilation for at least 24 hours; additionally, they require intravenous administration either as an infusion or bolus injection in 72 hour intervals (but will be recruited before that period)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05867472.