RecruitingNAINTERVENTIONAL

High-flow Oxygen for Vaso-occlusive Pain Crisis

This study is for adults with sickle cell disease who are experiencing a painful crisis. These crises can sometimes lead to a serious lung problem called acute chest syndrome. We're testing a new way of giving oxygen, called high-flow nasal oxygen (HFNO), compared to the usual method. HFNO delivers oxygen through a nose tube at a higher speed and can be warmed and humidified. The aim is to see if this special oxygen helps ease the pain crisis and prevents the lung problem from developing, which is important because there isn't a completely effective treatment for these issues right now. We'll compare different strengths of this oxygen to find the safest and most helpful approach.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

350

Start

27 Apr 2020

Estimated completion

27 Nov 2025

Sickle Cell Disease

What is this study about?

Sickle cell disease is a lifelong condition that causes red blood cells to become stiff and C-shaped, like a sickle. When this happens, they can get stuck in small blood vessels, blocking blood flow and causing sudden, severe pain. These painful episodes are often called 'pain crises' or 'vaso-occlusive crises' (VOCs). Sometimes, these pain crises can lead to a very serious lung condition called acute chest syndrome (ACS), which is a major concern for people with sickle cell disease.

Currently, when someone has a pain crisis, doctors usually manage the symptoms with things like pain relief and fluids. While oxygen is often given to make sure blood oxygen levels stay healthy, there isn't a specific treatment to stop the crisis quickly or prevent ACS. This study wants to explore if a different method of giving oxygen, called high-flow nasal oxygen (HFNO), could be more effective. HFNO is different because it delivers oxygen through a small tube in your nose at a faster rate, and the oxygen can be warmed and moistened to make it more comfortable.

We believe HFNO might help in a few ways. Firstly, delivering more oxygen could help regular red blood cells carry oxygen better and might even help sickle cells return to a normal shape, which could reduce pain. Secondly, the higher flow of air might help keep small airways open in the lungs, potentially preventing ACS. This study will compare different strengths of HFNO with the standard way of giving oxygen to see if it can safely and effectively reduce pain during a crisis and prevent the development of serious lung problems.

Key takeaways

This study explores a new oxygen treatment for sickle cell pain crises.
It aims to reduce pain and prevent serious lung complications like acute chest syndrome.
High-flow nasal oxygen (HFNO) is being compared to standard oxygen therapy.
Participation involves receiving oxygen through a nasal tube and routine medical checks.
The study is for adults with sickle cell disease experiencing a pain crisis.

Who may be eligible?

This study is looking for adults aged 18 or older who have a diagnosis of sickle cell disease (like SS, SC, Sβ0, or Sβ+ types) and are currently experiencing a painful crisis. This crisis must be causing pain in specific areas like your limbs, back, chest, or head, requiring pain medication, and not be due to other obvious causes.

You might be considered for the study if your doctors believe you are at a moderate to high risk of developing acute chest syndrome (a serious lung problem) based on certain blood test results or how severe your pain is. You'll also need to be able to give your informed consent, meaning you understand the study and agree to take part.

However, you won't be able to join if you already have acute chest syndrome, or if your current pain crisis has lasted longer than 72 hours and still needs strong pain medication. We also can't include people who are pregnant or breastfeeding, have certain heart or brain conditions, are already in another research study, or have an illness that prevents them from using the nasal oxygen device.

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.

Are you 18 years old or older?
Do you have sickle cell disease (e.g., SS, SC, Sβ0, or Sβ+)?
Are you currently having a pain crisis that needs strong pain relief?
Do you *not* currently have a lung problem called primary acute chest syndrome?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive oxygen through a special tube placed in your nose. The study will compare different settings for this oxygen: either the usual low-flow oxygen, or different strengths of high-flow oxygen. You might have blood tests, undergo examinations by the study doctors, and be asked about your pain levels and comfort. The high-flow oxygen device is called AIRVO 2, and it can be used in hospital wards. The total duration of your participation will depend on how long your pain crisis lasts and the follow-up needed, but the oxygen treatment itself is typically used during your hospital stay for the crisis.

Potential risks and benefits

Potential benefits of taking part could include receiving a treatment that might reduce your pain more effectively or help prevent serious lung problems during your pain crisis. However, HFNO is still being studied for sickle cell pain crises, so we don't know for sure if it will be better than current treatments. As with any medical procedure, there could be some risks, such as discomfort from the nasal tube or changes in your oxygen levels, which the study team will monitor closely. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Henri Mondor
Verified postcode
Créteil, France· Recruiting

Common questions

What is a 'pain crisis' in sickle cell disease?

It's when sickled red blood cells block blood flow, causing sudden, severe pain in different parts of your body. It's also called a vaso-occlusive crisis.

What is 'acute chest syndrome'?

It's a serious lung problem that can happen during a sickle cell pain crisis. It can make it hard to breathe and is a common cause of serious illness.

How is 'high-flow nasal oxygen' different?

It delivers oxygen through a small tube in your nose at a faster speed, and the oxygen can be warmed and moistened for comfort, potentially helping more than standard oxygen.

Will I know which oxygen treatment I'm getting?

This study is designed to compare different oxygen treatments safely. The study team will manage your care based on the study's protocol.

Can I still receive my usual pain medication if I join?

Yes, standard care for pain relief and other treatments will continue alongside the study's oxygen therapy.

How to find out more

Armand Mekontso, MD, PhD

armand.dessap@aphp.fr +33 (1) 49 81 23 94 Official trial record

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