RecruitingNAINTERVENTIONAL

Apnoeic Oxygenation During Pediatric Tracheal Intubation

This research wants to find out if using a technique called 'apnoeic oxygenation' makes anaesthesia safer for children. During some operations, children need a breathing tube, and their oxygen levels can sometimes drop quickly. This study will see if giving extra oxygen through a small tube in the nose during this short period helps prevent oxygen levels from falling too low. They are focusing on children aged from newborns up to 6 years old having planned surgery. The study involves separating children into two groups: one receiving the extra oxygen and one not. This will help doctors understand if this method improves safety and reduces problems during anaesthesia.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital Heidelberg

Enrolment target

200

Start

09 Sep 2024

Estimated completion

31 Aug 2025

Anesthesia Airway Complication of Anesthesia Anesthesia; Adverse Effect

What is this study about?

Imagine your child needs an operation, and for a short time during the anaesthetic, they'll need help breathing. Sometimes, children's oxygen levels can drop faster than adults' during this period, which can be worrying. This study is looking into a way to help prevent this from happening.

The technique they're studying is called 'apnoeic oxygenation'. It means gently giving a little extra oxygen through a thin tube placed near your child's nose while they are going to sleep and before a breathing tube is fully in place. The idea is that this extra oxygen acts like a small boost, giving doctors more time to safely manage your child's breathing without their oxygen levels getting too low. This is particularly important because children use oxygen very quickly.

The researchers want to see if this method works well in children aged from newborns up to 6 years old who are having planned surgery. They are divided into two main groups: infants (up to 2 years) and older children (2 to 6 years). Within these groups, some children will receive this extra oxygen, and others won't, to see if there's a clear benefit. The aim is to make anaesthesia as safe as possible for children, especially by reducing the chance of oxygen levels dropping too much during an operation.

Key takeaways

Tests a method to keep children's oxygen levels up during anaesthesia.
Focuses on children aged newborn to 6 years undergoing planned surgery.
Compares standard care with a gentle extra oxygen technique.
Aims to make anaesthesia safer and reduce related problems.
Your child's participation is limited to the time of their operation.

Who may be eligible?

This study is looking for children who are aged between birth and 6 years old. They should be generally healthy or have mild to moderate health conditions that are well-managed. The child must be having an operation that has been planned in advance and requires a general anaesthetic.

There are certain reasons why a child would not be able to join the study. If a child has a life-threatening illness, is already on oxygen before their surgery, or has injuries or unusual features around their nose, mouth, or throat that would make the extra oxygen method difficult, they cannot take part. Additionally, children with certain heart conditions that cause low oxygen levels naturally, or those needing emergency surgery, would not be suitable.

Also, for practical reasons, if the parents or guardians have difficulty with the language spoken by the hospital staff, or if they prefer not to take part, the child would not be included. The study also cannot include children if the doctors in charge feel it wouldn't be appropriate, or if the special paediatric anaesthesia doctor isn't available.

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 aged between birth and 6 years?
Is your child having planned, rather than emergency, surgery?
Is your child generally healthy, or do they have well-managed mild to moderate health issues?
Are there any facial or throat injuries or known unusual features around their mouth/nose area?
Is your child currently on oxygen therapy at home?
Do you speak and understand English well enough to discuss the study fully?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will be randomly assigned to one of two groups, like flipping a coin. One group will receive the 'apnoeic oxygenation' during their anaesthetic induction, which involves a small tube delivering oxygen near their nose. The other group will not receive this extra oxygen. You won't know which group your child is in; this is a common approach in studies to ensure fair results. The anaesthetic process will otherwise be the same as standard care. Doctors will carefully monitor your child's oxygen levels and other vital signs, as they would during any anaesthetic. All measurements will be made during the standard anaesthesia process. There are no extra hospital visits or follow-up appointments specifically for this study. The study focuses purely on what happens during the anaesthesia itself.

Potential risks and benefits

The potential benefits of this study include helping to make anaesthesia safer for children by finding out if apnoeic oxygenation effectively prevents low oxygen levels during an operation. This could lead to better care for many children in the future. The risks directly related to receiving the extra oxygen via a nasal tube are considered very low. It's a method already used in some situations, and the amount of oxygen is carefully controlled. As with any medical study, you are always free to change your mind and withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University,
Verified postcode
Heidelberg, Germany· Recruiting

Common questions

What is 'apnoeic oxygenation'?

It's a way of giving extra oxygen gently through a small tube in the nose while a child is going to sleep and before a breathing tube is put in place for an operation.

Why is this study important for children?

Children's oxygen levels can drop quickly during anaesthesia. This study aims to find a simple way to help prevent this, making anaesthesia safer for them.

Will my child feel anything different if they get the extra oxygen?

No, your child will be asleep during the process, so they won't feel anything different from a standard anaesthetic.

How long will my child be in the study?

Your child's participation is focused only on the anaesthetic process itself during their planned operation. There are no extra appointments or long-term follow-ups for the study.

Will I know if my child received the extra oxygen?

No, you won't know which group your child is in. This helps ensure the study results are fair and unbiased.

How to find out more

Davut Deniz Uzun, Dr. /MD

deniz.uzun@med.uni-heidelberg.de +49 62215639349 Official trial record

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