Not yet recruitingOBSERVATIONAL

Impact of Early Mobilization on SAH Patients Physiological Parameters

This research is investigating the effects of helping patients who have had a brain bleed, called a subarachnoid haemorrhage (SAH), to get out of bed early. These patients are in intensive care. Historically, people stayed in bed for a long time, but now doctors think moving sooner might be better. This study will carefully measure how this early movement affects important body functions, especially in the brain, lungs, and heart. Researchers will use special equipment like lung scanners and brain monitors during clinical exams to see if moving early causes any changes. The goal is to understand if getting out of bed sooner is safe and beneficial for recovery after a brain bleed.

At a glance

Status

Not yet recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

100

Start

01 Mar 2024

Estimated completion

01 Feb 2027

Subarachnoid Hemorrhage

What is this study about?

If you or someone you care about has had a subarachnoid haemorrhage (SAH), which is a type of bleeding in the space around the brain, they might be in intensive care. For a long time, doctors thought it was best for these patients to stay in bed for a long time. However, more recently, doctors have started to believe that moving around a bit earlier might actually help with recovery and prevent other problems.

This study wants to find out exactly what happens in the body when these patients start to get out of bed sooner. The researchers will be looking very closely at different systems in the body, including the brain, the lungs, and the heart. They want to see how these important parts of the body react to early movement. This information will help doctors understand if getting patients out of bed sooner is truly beneficial and safe, and it could help improve how SAH patients are cared for in the future.

To do this, the research team will use special, gentle tools during regular checks. These tools include a lung scanner to see how the lungs are working, a special monitor to check blood flow in the brain, and another device to look at oxygen levels in the brain. They will also do careful physical examinations. By gathering all this information, they hope to get a clear picture of how early movement affects the body's vital functions after a subarachnoid haemorrhage.

Key takeaways

This study examines how early movement affects patients after a serious brain bleed.
It focuses on patients in intensive care with a subarachnoid haemorrhage.
Researchers will monitor brain, lung, and heart activity during movement.
The aim is to see if early movement is safe and beneficial for recovery.
Participation involves extra monitoring during regular care, not new treatments.

Who may be eligible?

This study is looking for adults aged 18 or older who have experienced a specific type of brain bleed called an aneurysmal subarachnoid haemorrhage (SAH). To join, your doctors must have successfully treated the bleed (meaning the aneurysm that caused it is 'secured') and you must be well enough for your first planned early move out of bed. Your overall condition, as assessed by doctors, should be within a certain range of severity after the bleed.

There are certain reasons why someone wouldn't be able to join. For example, if you are heavily sedated (given medicine to keep you very sleepy) or if your awareness is significantly disturbed or you are in a coma, you wouldn't be able to take part. Also, if the brain bleed hasn't been fully treated and the cause is 'unsecured', you can't join.

Finally, if you are under legal protection that restricts your ability to make your own decisions (like guardianship or curatorship), you wouldn't be eligible for this study.

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?
Have you had a brain bleed called an 'aneurysmal subarachnoid haemorrhage' that has been treated?
Are your doctors planning for you to have your first early movement out of bed?
Are you not heavily sedated or in a coma?
Are you capable of making your own medical decisions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue to receive the best possible care from your medical team. The main difference is that during your planned early movements out of bed, the research team will gently use some special equipment to monitor your body. This will involve using a lung scanner (like an ultrasound on your chest), a device to check blood flow in your brain (Transcranial Doppler), and a monitor to look at oxygen levels in your brain (NIRS). They will also do careful clinical examinations, which are standard checks doctors already do. These extra checks are done to gather information for the study and shouldn't add significant time or discomfort to your regular care. The study focuses on this early period of mobilisation while you are in intensive care, so there won't be long-term follow-up visits specifically for this study once you leave the ICU.

Potential risks and benefits

Taking part in this study means doctors will be monitoring your body very closely during your early movements, which could help them learn more about your condition. The main benefit is the potential for doctors to gain valuable knowledge that could improve care for future patients with brain bleeds. The risks involved are generally very low; the monitoring equipment used is non-invasive and routinely used in hospitals. There are no additional medications or treatments in this study. The study aims to understand the physiological effects of an already planned part of your care. You always have the right to change your mind and withdraw from the study at any time, without it affecting your medical care.

Locations (1)

Adéla FOUDHAÏLI
Verified postcode
Paris, France

Common questions

What is a subarachnoid haemorrhage?

It's a type of bleeding around the brain, often caused by a burst blood vessel, which is a serious medical emergency.

What does 'early mobilisation' mean?

It means helping you get out of bed and move around, even a little, earlier than might have been done in the past, often while you're still in intensive care.

Will I have to do anything extra special?

No, you will be receiving your usual care. The research team will simply add some extra monitoring during your planned times of getting out of bed.

Are the monitoring devices painful?

No, the devices used like the lung scanner and brain monitors are gentle and non-invasive, similar to what doctors already use regularly.

Will this study change my medical treatment?

No, this study is observing the effects of your current care. It won't change the treatments your doctors believe are best for you.

How to find out more

Adéla FOUDHAÏLI, Physiotherapist

adela.foudhaili@aphp.fr 0149956305 Official trial record

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