All studies
Not yet recruitingNAINTERVENTIONAL

Feasibility of Protocolised Analgosedation in ECMO

This study aims to find out if it's possible to run a larger trial comparing a new plan for giving painkillers and sedatives to patients on a life-support machine called ECMO, against the usual care. ECMO helps severely ill patients whose hearts or lungs aren't working properly. Giving the right amount of these medicines is tricky: too much can cause confusion and memory issues later, while too little can mean pain. Many ECMO patients face long-term problems like anxiety and memory issues, which might be linked to sedation. If successful, this study could lead to a bigger trial to improve patient comfort and long-term recovery for those on ECMO.

At a glance

Status
Not yet recruiting
Phase
NA
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Enrolment target
60
Start
01 Sep 2026
Estimated completion
31 Aug 2027

What is this study about?

When someone is very poorly and needs help breathing or with their heart, doctors might use a special life support machine called ECMO. This machine helps provide oxygen and removes waste gases from the body. Patients on ECMO often need medicines to help with pain and to keep them calm and comfortable. These medicines are called painkillers and sedatives. Giving the right amount is really important: too much can make patients confused or forgetful, and too little can cause pain and distress. Currently, there isn't a clear guide or `protocol` for giving these medicines specifically to ECMO patients, and doctors find it hard to get it just right.

This study wants to see if we can create and test a new, step-by-step plan for giving these painkillers and sedatives to ECMO patients. The main goal of this particular study isn't to say whether the new plan is definitely better, but rather to find out if it's even possible to run a bigger study about it. They want to check if their ideas for the study make sense, if doctors and nurses can follow the new plan easily, and how many patients would be willing to take part.

The idea is to improve how patients feel while on ECMO and reduce long-term problems like anxiety, memory issues, or mobility problems that some ECMO survivors experience. By working out if a research study of this new plan is "doable," it could pave the way for a larger study that might ultimately lead to better care and a smoother recovery for ECMO patients in the future.

Key takeaways

  • Exploring better ways to manage pain and relaxation for very sick ECMO patients.
  • Aims to reduce long-term problems like memory issues and anxiety after ECMO.
  • This is a 'feasibility' study, checking if a bigger research project is possible.
  • Compares a new guide for medicines against current standard care.
  • Patient and family feedback helped design this study.

Who may be eligible?

To be considered for this study, you would need to be 18 years old or older. You must also be receiving continuous painkillers and sedatives through an IV (a drip into your arm) and currently be on ECMO treatment.

There are no specific reasons that would stop someone from joining, as the way painkillers and sedatives are managed is a routine part of care for all adults on ECMO. This means that if you meet the main criteria mentioned above, you could be eligible to take part.

Quick self-check
  • Are you 18 years old or older?
  • Are you currently receiving continuous painkillers and sedatives through an IV drip?
  • Are you currently undergoing ECMO treatment?
  • Do you have any known reason that would make managing your pain or relaxation medicines impossible under normal circumstances?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would be put into one of two groups. One group would receive the usual care that doctors and nurses already provide, and the other group would receive care using a new, specific plan for giving painkillers and sedatives. The study team would then collect information from both groups, primarily to see if the study is set up in a way that works well and to find out how many patients agree to join.

Your participation would involve the study team gathering details about your medical care, such as how long you need mechanical ventilation, how long you are on ECMO, and the amounts of painkillers and sedatives you receive. They would also look at scores related to pain, how awake you are, and whether you experience confusion. This information would be collected as part of your normal medical care. The total duration of your participation would be for as long as you are receiving ECMO treatment and possibly for a short period afterwards to gather necessary data.

Potential risks and benefits

Potential benefits of taking part include contributing to research that could improve how patients on ECMO are cared for in the future, potentially leading to better comfort and long-term recovery for others. For you personally, there is no guarantee of direct benefit, as this is a feasibility study, meaning it's primarily testing if a larger study is possible. Risks are expected to be minimal as the study focuses on how existing medications are managed. There might be a risk of emotional discomfort from discussing your condition or care, but safeguards would be in place. Remember, you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

  • Guy's and St Thomas' NHS Foundation Trust
    London, United Kingdom

Common questions

What is ECMO?

ECMO is a life support machine that helps very sick patients whose hearts or lungs aren't working properly, by providing oxygen and removing waste gases like carbon dioxide from their blood.

What are painkillers and sedatives?

Painkillers are medicines to relieve pain, and sedatives are medicines that help you relax, feel calm, and sometimes make you drowsy or sleep. They are often given together in intensive care.

What is a 'sedation protocol'?

A sedation protocol is a step-by-step guide or plan for healthcare staff on how to best give painkillers and sedatives to patients, aiming to give just the right amount.

Why is this study important for ECMO patients?

It's important because finding a better way to manage painkillers and sedatives for ECMO patients could help reduce long-term problems like anxiety and memory issues, leading to a better recovery.

Will taking part change my current medical care?

If you join the 'new plan' group, your sedation management will follow a specific guide. If you're in the 'usual care' group, your care will continue as it would normally. Your overall medical care will not be negatively affected.

How to find out more

Christopher Remmington, MPharm

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

Interested in taking part?

Register your interest

Share your details and the research team for "Feasibility of Protocolised Analgosedation in ECMO…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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