RecruitingNAINTERVENTIONAL

High Flow Oxygen Therapy After Spinal Cord Injury

This study is exploring a different way to give oxygen, called high-flow oxygen therapy, to patients who have had a spinal cord injury in their upper back or neck. The main aim is to understand if this new therapy can be safely and effectively used in hospitals. We'll be looking at whether it's possible to include enough patients in the study, if the study plan is easy to follow, and what impact this therapy might have on patients. Some participants will receive the high-flow oxygen therapy while others will get regular care for 10 days after their injury. The goal is to improve breathing issues often seen after these types of injuries.

At a glance

Status

Recruiting

Phase

Sponsor

Cardiff and Vale University Health Board

Enrolment target

Start

01 Apr 2024

Estimated completion

01 Aug 2026

Spinal Cord Injuries Respiratory Failure

What is this study about?

When someone has a spinal cord injury, especially in the neck or upper back, it can sometimes affect their breathing. This is because the injury can weaken the muscles used for breathing. Breathing problems are quite common after these injuries and can lead to other issues like lung infections. Currently, doctors use standard methods to help with breathing, but researchers are always looking for better ways to support patients and prevent serious complications.

This study aims to investigate a new method called 'high-flow oxygen therapy'. This therapy delivers warm, moist oxygen through a soft tube placed in the nose. The study wants to find out if this treatment is a good option for people with spinal cord injuries. It's a 'feasibility study', meaning the main goal is to learn if this new treatment can be easily given to patients and if the study plan makes sense to follow. It's an important first step to see if this new approach could eventually help improve breathing and recovery for patients.

Participants in the study will be divided into two groups by chance – like flipping a coin. One group will receive the new high-flow oxygen therapy for 10 days, while the other group will receive the usual care that doctors already provide. By comparing these two groups, doctors hope to understand if high-flow oxygen therapy can make a difference in how patients recover from breathing difficulties after their spinal cord injury.

Key takeaways

This study explores a new oxygen therapy for spinal cord injuries.
It aims to make breathing easier and prevent complications.
Participants will receive either new therapy or standard care, randomly chosen.
The study lasts 10 days while you're in hospital.
It's a 'feasibility' study, checking if the new therapy is practical to use.
Your care will not be affected if you choose not to take part.

Who may be eligible?

To be considered for this study, you would need to have suffered a spinal cord injury that affects your spine between the C4 and T4 levels (which is around your neck and upper back). You would also need to have been admitted to a special spinal injury ward within 24 to 48 hours of your injury.

There are certain reasons why someone might not be able to join the study. For example, if you are under 18 years old, or if you have certain other injuries like three or more broken ribs, a broken breastbone, or another lung injury. You also wouldn't be able to join if you had conditions that make high-flow oxygen therapy unsuitable, such as certain facial injuries, a severe nosebleed, or a recent sinus operation. Additionally, if doctors can't get your informed permission to take part, you wouldn't be able to participate.

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 spinal cord injury between your neck (C4) and upper back (T4)?
Were you admitted to a spinal injury ward within 24-48 hours of your injury?
Are you 18 years old or older?
Do you have certain other injuries like many broken ribs or a severe facial injury?
Can you give your consent (permission) to take part?

Answer every question to see your result.

What does participation involve?

If you join this study, your participation would last for 10 days. During this time, you would either receive the new high-flow oxygen therapy or the standard oxygen care, depending on which group you're randomly assigned to. You wouldn't need to visit a special clinic for the study; all care would be provided while you are in the hospital. Doctors and nurses would regularly monitor your breathing and overall condition, just as they would with any patient with a spinal cord injury. There are no additional medications specifically for the study itself beyond your usual medical treatment.

Potential risks and benefits

Taking part in this study could potentially help us learn more about improving breathing support for people with spinal cord injuries, which might benefit future patients. The high-flow oxygen therapy is already used in other medical situations and is generally considered safe, but as with any medical treatment, there can be very rare risks or discomforts, which your doctor will discuss with you. You have the right to withdraw from the study at any time without giving a reason, and this would not affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Cardiff and Vale University Health Board
Verified postcode
Cardiff, United Kingdom· Recruiting

Common questions

What is 'high-flow oxygen therapy'?

It's a way of giving warm, moist oxygen through soft tubes in your nose to help with breathing.

Why is this study being done?

It wants to see if this new oxygen therapy can safely and practically help people with spinal cord injuries who have breathing difficulties.

Will I definitely get the new therapy if I join?

No, you will be randomly assigned to either receive the new therapy or the standard care, like flipping a coin.

How long will I be in the study?

If you participate, you will receive the assigned therapy for 10 days after your injury.

Can I leave the study if I change my mind?

Yes, you can leave the study at any point without it affecting your medical care.

How to find out more

Paul Twose, MSc

paul.twose@wales.nhs.uk 07739315830 Official trial record

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