RecruitingPHASE3INTERVENTIONAL

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

This study is about helping children who are very ill and need a breathing machine to support them. Sometimes, these children can become very confused, which doctors call delirium. This study is testing if a special inhaled medicine, similar to the gas used in operations, can help keep children calm and prevent this confusion more effectively than the usual medicines given through a drip or by mouth. It's a pilot study, meaning it's a small-scale test to make sure the plan for a larger study is good. The main things it wants to find out are if enough families are willing to take part, if children can complete the study, and if the hospital staff can easily fit the study into their routine. The aim is to see if this new approach can eventually lead to better brain recovery for these children.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

Start

10 Oct 2023

Estimated completion

01 Dec 2026

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

What is this study about?

This research is looking into better ways to care for children who are very poorly and need help breathing with a machine called a ventilator, often in an intensive care unit. When children are this ill and on a ventilator, they sometimes experience severe confusion, known as delirium, which can be upsetting for them and their families.

The study wants to see if giving a calming medicine as an inhaled gas (like a special air they breathe) could be a better option than the usual calming medicines given through a drip (into a vein) or by mouth. This inhaled medicine is similar to the 'gas' adults might breathe in for an operation. The hope is that this new approach might help prevent confusion and lead to better overall recovery for these children, especially with their brain function.

This is a 'pilot study', which means it's a small, initial study. It's designed to make sure that the way the study is set up makes sense and works well before a much larger study is done. The researchers want to check if families are happy to join, if children can stay in the study for the full time, and if the hospital staff can manage the new treatment easily. If this pilot study goes well, it could lead to bigger research that might change how these very ill children are cared for.

Key takeaways

Tests if an inhaled medicine can reduce confusion in sick children on breathing machines.
Compares it to standard calming medicines given through a drip.
A small 'pilot' study to check if a bigger study is possible.
Includes a follow-up check on memory and thinking after 9-12 months.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is for children aged from one month old up to 18 years old who are seriously ill and need a breathing machine (ventilator) to help them breathe. They must already be receiving calming medicine through a drip or by mouth to help them tolerate the breathing machine, and are expected to need the ventilator for at least 24 hours.

There are certain reasons why a child might not be able to join. For example, if they have a history of a rare reaction called malignant hyperthermia, or if they are allergic to certain inhaled gases. Children with specific heart, lung, or muscle conditions that could react badly to the inhaled medicine cannot take part. Also, if a child is so unwell that they are not expected to live for more than 24 hours, or if they have certain conditions that cause pressure in the brain, they won't be eligible.

Other reasons for not being able to join include if a child is already using certain breathing medicines that might interfere with the study's equipment, if the breathing machine circuit isn't sealed properly (which would let the inhaled medicine escape), or if they are pregnant or breastfeeding. We want to make sure the study is as safe as possible for every child involved.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child between 1 month and 18 years old?
Does your child currently need a breathing machine (ventilator)?
Is your child already getting calming medicine through a drip or by mouth?
Is your child expected to need the breathing machine for at least 24 hours?
Does your child have a history of certain allergies or rare medical conditions that might react to inhaled gases?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will be randomly chosen to receive either the new inhaled calming medicine or the standard calming medicine they would usually get through a drip. Neither you nor the doctors will choose which group your child is in; it's like flipping a coin to make it fair. Both groups of children will be cared for in the intensive care unit as usual.

Your child's condition will be monitored every day for up to 28 days while they are in the hospital. The medical team will keep a close eye on them, just as they would with any child in intensive care, but they will also specifically look for any signs of confusion.

After leaving the hospital, when your child has had time to recover (usually between 9 and 12 months later), they will be invited back for an assessment. This will involve some tasks and games to check their memory, thinking skills, and behaviour. The total duration of the direct study treatment is up to 28 days, with a follow-up assessment almost a year later.

Potential risks and benefits

Taking part in any study has potential benefits and potential risks. The potential benefit of this study is that the inhaled medicine might help prevent confusion during critical illness and improve how a child's brain recovers later on. However, we don't know for sure yet, which is why we are doing the study. Both the study medicine and the standard care medicines have known risks and side effects, and your child's medical team will discuss these with you. You, or your child if they are old enough to understand, have the right to withdraw from the study at any time, for any reason, without it affecting your child's medical care.

Locations (3)

McMaster Children's Hospital
Verified postcode
Hamilton, Canada· Recruiting
Children's Hospital - London Health Sciences Centre
Verified postcode
London, Canada· Recruiting
The Hospital for Sick Children (SickKids)
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is the main goal of this study?

The main goal is to see if an inhaled calming medicine can reduce confusion and help with brain recovery in critically ill children on breathing machines, compared to standard medicines.

What does 'randomised' mean?

Randomised means your child will be put into one of two groups by chance, like drawing lots. One group gets the inhaled medicine, and the other gets the usual drip medicine, to make the comparison fair.

How long will my child be in the study?

Your child will be monitored daily for up to 28 days in the hospital. Then, about 9-12 months later, they will have a follow-up visit to check their memory and thinking.

Will my child's regular care be affected?

No, your child will receive the same high standard of intensive care, regardless of whether they are in the study or not. Taking part will not affect their normal medical treatment.

Can we change our mind about participating?

Yes, you can decide to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

How to find out more

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

abovetrial@sunnybrook.ca 416-480-6100 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.