RecruitingOBSERVATIONAL

Improving Sedation Practice in Critically Ill Adult Patients Using a Co-designed Sedation Protocol

This study focuses on improving how sedation (painkillers and relaxing medicines) is used for critically ill adults on a life support machine called ECMO. ECMO helps patients whose heart or lungs are failing. While ECMO saves lives, many survivors face long-term problems like anxiety and memory issues, which might be linked to sedation. We know that current sedation practices for ECMO patients are challenging, and there isn't a specific guide to help. This research first looks at how sedation is currently given across the UK. Then, crucially, it will work with patients, their families, and healthcare staff to develop a new, clear guide for sedation that aims to reduce long-term problems and improve recovery. This guide will then be tested to ensure it's safe and helpful.

At a glance

Status

Recruiting

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrolment target

120

Start

24 Nov 2025

Estimated completion

31 Aug 2027

Intensive Care Medicine Respiratory Distress Syndrome (RDS)Sedation and Analgesia ExtraCorporeal Membrane Oxygenation (ECMO)Sedation for Mechanical Ventilation Cardiogenic Shock Opioid Analgesia Analgesia

What is this study about?

This research is all about making sure critically ill patients in intensive care get the right amount of medication to help them stay comfortable and reduce pain. These medicines are called sedation. We're particularly focusing on patients who are on a special life support machine called ECMO. ECMO helps people whose lungs or heart are so sick they can't work properly, by providing oxygen and removing waste gases from their blood. While ECMO is a life-saving treatment, we know that many patients who survive it can experience lasting problems like anxiety, memory issues, and difficulties with movement. We suspect that the way sedation is given might play a big part in these long-term challenges.

Currently, there isn't a clear, agreed-upon guide for how much sedation to give to ECMO patients. Healthcare staff often find it tricky to get it just right. Giving too much sedation can make patients confused, overly sleepy, and lead to longer hospital stays. On the other hand, too little sedation can cause pain, distress, and also delay recovery. We've seen in other critically ill patients (not on ECMO) that having a clear guide can significantly reduce these problems, so we believe a similar approach could really help ECMO patients too.

The study has two main parts. First, we'll look at how sedation is currently being used for ECMO patients across different hospitals in the UK and compare it to other seriously ill patients. This will help us understand the current situation. Second, and very importantly, we're going to work with patients who have been on ECMO, their families, and the healthcare staff who look after them. Together, we will create a new guide for giving sedation. The aim is for this guide to be acceptable and safe, helping to ensure ECMO patients receive the best possible care, aiming for a better recovery and fewer long-term health problems.

Key takeaways

Aiming to improve pain relief and relaxation (sedation) for critically ill patients on ECMO life support.
Developing a new sedation guide by working with patients, families, and healthcare staff.
Observing current sedation practices in UK hospitals to understand what's happening now.
The goal is to reduce long-term problems like anxiety and memory issues often seen in ECMO survivors.
This study does not involve new treatments for patients; it's about improving existing care practices.
Findings will be shared widely to benefit future ECMO patients across the UK.

Who may be eligible?

This study is split into two stages, and who can take part differs for each.

For the first stage, which looks at current sedation practices, we'll be observing adult patients (aged 18 or over) in intensive care who are receiving continuous drips of pain relievers or sedatives. This includes patients on an ECMO machine for severe breathing problems, as well as other critically ill patients who are on a breathing machine for severe breathing, heart, or circulation issues.

Patients would not be included if they are expected to be in the intensive care unit for less than 24 hours, or if there is a plan to withdraw life support within the next 24 hours. For the second stage, where we develop the new sedation guide, we're looking for different groups to get involved. This includes healthcare professionals working in specific ECMO centres, as well as patients who have survived being on ECMO and have since recovered and returned home. We also welcome family members of ECMO survivors, whose loved one is no longer in hospital. Unfortunately, we can't include ECMO survivors who are currently in hospital, have severe memory or thinking problems, or cannot communicate in English, or anyone who hasn't been on ECMO.

Quick self-check

Are you 18 years old or older?
Are you currently receiving continuous pain relief/sedation as an adult intensive care patient (for stage 1)?
Have you been on an ECMO machine for severe breathing problems within the last 7 days (for stage 1)?
Are you an ECMO survivor who has returned home, or a family member of an ECMO survivor (for stage 2)?
Are you a healthcare professional working in an ECMO centre (for stage 2)?
Can you communicate in English (for stage 2 participants)?

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

What does participation involve?

This study is not about trying out a new treatment directly on patients. Instead, it involves two main parts:

**Stage 1: Looking at Current Practices** For patients in intensive care, this stage involves the study team collecting information about the medicines they are already receiving for pain and relaxation (sedation). This includes details about the doses given and how pain and sedation levels are monitored. Healthcare staff will record this information as part of their routine care. There are no extra tests or visits for patients. Data will be collected until discharge from the intensive care unit.

**Stage 2: Developing a New Sedation Guide** This stage involves group discussions and meetings. If you are a healthcare professional, an ECMO survivor, or a family member of an ECMO survivor, you would be invited to attend meetings. In these meetings, you would share your experiences and ideas about sedation for ECMO patients. The goal is to agree on what should be included in a new sedation guide. These meetings would likely involve a few sessions, and then the proposed guide would be shared with a wider group of staff for their feedback.

Potential risks and benefits

This study does not involve giving new medicines or treatments; therefore, there are no direct medical risks to the patients being observed. For those participating in the discussion groups (patients, families, staff), the main risk might be discomfort in sharing personal experiences, though we will create a supportive environment. The potential benefits for patients include improving future care by helping to develop a sedation guide that could lead to better comfort during critical illness and improved long-term recovery for ECMO patients. Participants in the discussion groups will have the benefit of contributing to meaningful improvements in patient care. Anyone is free to withdraw from contributing to the discussion groups at any time without giving a reason.

Locations (1)

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

Common questions

What is ECMO?

ECMO stands for Extracorporeal Membrane Oxygenation. It's a life support machine for very sick patients whose heart or lungs aren't working well enough. It takes over the job of providing oxygen and removing waste gases from the blood.

What is sedation?

Sedation refers to medicines that help patients relax, reduce pain, and stay comfortable, often making them sleepy. It's crucial in intensive care to help patients cope with their illness and treatments.

Why is a sedation guide needed for ECMO patients?

Currently, there isn't a specific guide for giving sedation to ECMO patients. We know that getting sedation levels just right can be challenging, and it might affect how well patients recover long-term. A guide aims to improve this.

Will I be given new medication if I take part?

No, this study is not about new medications. For patients, we will only be observing and gathering information about the pain and relaxation medicines you are already being given as part of your normal care.

How will the study findings be used?

The findings will be shared with other hospitals, patient groups, and through research papers. The main goal is to create a new, improved sedation guide for ECMO patients, which we hope will be used throughout the UK.

How to find out more

Christopher Remmington, MPharm

christopher.remmington@nhs.net +442078365454 Official trial record

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