Feasibility of Protocolised Analgosedation in ECMO

NCT07580781 | Not Yet Recruiting

• 2 other identifiers: IRAS number: 354798NIHR304092
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

extracorporeal membrane oxygenation; sedation; opioid; sedative; analgosedation; mechanical ventilation; ECMO; ICU; Intensive Care Unit; Critical Care; sedation protocol; analgesia

Outcome Measures

Primary Outcomes (1)

• Feasibility of protocolised sedation

  Ability to; 1. Assess fidelity of intervention delivery (adherence to the study protocol) 2. Establish barriers and facilitators to trial conduct and intervention delivery 3. Assess the feasibility of data collection methods 4. Assess the acceptability of the co-designed analgosedation protocol from the perspectives of nursing, medical, and pharmacy staff using it.

  From date of randomisation to the end of treatment at 10 days, assessed up to 10 days

Secondary Outcomes (13)

• Duration of mechanical ventilation

  Defined as date of randomisation until first successful unassisted breathing (no inspiratory support for 48hrs or ECMO) or death or hospital discharge (at recruiting site), assessed up to 30 days. Censor at hospital discharge in recruiting centre.

• Occurrence and duration of delirium

  From date of randomisation to 10 days or death or transfer if occurs first, assessed up to 10 days.

• Duration of ECMO treatment

  From date of randomisation to ECMO decannulation, assessed up 30 days.

• Daily morphine equivalent doses

  From date of randomisation to 10 days or death/transfer if occurs first, assessed up to 10 days.

• Daily midazolam equivalent doses

  From date of randomisation to 10 days or death/transfer if occurs first, assessed up to 10 days.

Study Arms (2)

Intervention arm - use of sedation protocol

OTHER

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.

Other: Sedation protocol

Standard of care for delivery of analgosedation and all other medical treatment while in the ICU

NO INTERVENTION

Will comprise the standard of care for delivery of analgosedation and all other medical treatment while in the ICU. Standard of care includes use of pain (Critical-Care Pain Observation Tool - CPOT), and sedation (Richmond Agitation and Sedation Scale - RASS) scores to assess pain and sedation levels, and the use of opioids and sedatives to keep patients comfortable and pain-free with drug type and dosing selected by the ICU clinical team. One cluster (ICU) will be randomly assigned to this arm.

Interventions

Sedation protocol OTHER

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.

Also known as: Analgosedation protocol

Intervention arm - use of sedation protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years and older
• Receiving IV continuous infusions of analgosedation medication
• Receiving ECMO treatment

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Related Publications (28)

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MeSH Terms

Conditions

Respiratory Distress Syndrome; Agnosia; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis; Shock

Study Officials

• Louise Rose, PhD

  King's College London

  STUDY CHAIR

Central Study Contacts

Christopher Remmington, MPharm

CONTACT

+442078365454; christopher.remmington@nhs.net

Louise Rose, PhD

CONTACT

+4478365454; louise.rose@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility cluster randomised controlled trial

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be made available following publication of research findings in peer-reviewed manuscripts and presentation at international conferences.
• Access Criteria: Institution access will be needed to access any data. This includes permission to access the specific university and hospital servers. Potential users will require tools including Microsoft Excel and Microsoft Word to access and use the data, which are widely adopted in many institutions and sustainable. The data will be shared via the University repository KORDS but it will not be openly accessible. Requests for access to the data will be handled directly by the research team in line with local policies.

Locations

GB (1)