Feasibility of Protocolised Analgosedation in ECMO

Summary

Sedation (painkillers and sedative drugs) treats pain, reduces suffering, and helps patients in the intensive care unit (ICU) receiving extracorporeal membrane oxygenation (ECMO) remain comfortable. ECMO is a life support machine that provides oxygen and removes waste gases (carbon dioxide) in very sick patients with severe heart or lung failure. About 300-400 patients per year receive ECMO in the UK. These patients are younger and generally more healthy compared to other critically ill patients. However patients that survive ECMO have long-term health problems. These include anxiety, memory problems, withdrawal from medicines, and mobility issues. These problems issues could all be related to the type and amount of sedation given.

A sedation protocol is a way of guiding healthcare professionals how much sedation is given to patients in ICU. Too much sedation can cause confusion, hallucinations, excessive sleepiness, and longer time in hospital. Too little sedation can cause pain, distress, and also a longer time in hospital. Using a sedation protocol in non-ECMO patients has been shown to reduce these complications.

However, there are no protocols for giving sedation to ECMO patients in research papers. Investigators know healthcare staff find it difficult to manage sedation, and higher amounts of sedation is given to ECMO patients.

Aims:

To see whether it is possible to run a trial that compares using a sedation protocol against usual care.

Design/methods:

Thirty to 60 ECMO patients will be chosen and will be put into one of two groups. One group will receive usual care, and the other will receive care using the sedation protocol. The investigators will collect information from both groups to find out if the study design works and how many patients agree to take part.

Patient and public involvement/engagement:

The investigators received feedback from patients and family member participants which helped to design this proposal, the lay summary and what to measure in a trial. They will advise how the investigators should review study findings, and support sharing of results to the public.

Impact/dissemination:

The investigators will share findings through social media, patient charities, research papers and conferences.

Conditions

• Intensive Care (ICU)
• Respiratory Distress Syndrome (RDS)
• Sedation and Analgesia
• Extracorporeal Membrane Oxygenation
• Sedation for Mechanical Ventilation
• Cardiogenic Shock
• Opioid Analgesia
• Analgesia

Interventions

OTHER

Sedation protocol

Will comprise the use of the previously co-designed analgosedation protocol. The analgosedation protocol will focus on setting a daily target for pain using the CPOT score, and sedation using the RASS score. The protocol will include recommended opioid and sedative medicines and their dose ranges, guidance on titration of opioid and sedative doses based on pain and sedation scores, daily interruption of sedation, use of non-pharmacological approaches to keep patients calm and to promote sleep, and methods of weaning opioids and sedatives. Patients will also be assessed daily for delirium using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). All other treatments will be as per standard care and at the discretion of the treating clinical team. The sedation protocol will be used for up to 10 days after commencement of ECMO. One cluster (ICU) will be randomly assigned to this arm.

Sponsors & Collaborators

• King's College London

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  lead OTHER

Principal Investigators

• Louise Rose, PhD · King's College London

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-08-31

Completion

2027-08-31

Countries

• United Kingdom

Study Locations