Actively Recruiting
Improving Sedation Practice in Critically Ill Adult Patients Using a Co-designed Sedation Protocol
Led by Guy's and St Thomas' NHS Foundation Trust · Updated on 2026-05-08
120
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. The investigators know healthcare staff find it difficult to manage sedation, and higher amounts of sedation is given to ECMO patients. Aims: * To describe current sedation use in ECMO patients in the UK and compare to non-ECMO critically ill patients. * To develop a sedation protocol for ECMO patients with input from patients, their family, and staff. Design/methods: Study 1: The investigators will study how sedation is used in adult ECMO patients and compare with non-ECMO but critically ill patients in the UK. The investigators will collect information on drug doses and pain and sedation scores. The investigators will also ask ECMO centres if they use a sedation protocol to adjust sedation doses. This information will be helpful for the design of the protocol in study 2. Study 2: The investigators will design a sedation protocol with input from patients, family, and staff. The investigators will organise meetings to share experiences and agree on what to include in the protocol that is considered acceptable and safe. The investigators will then assess if the protocol is safe and acceptable with staff outside the co-design group. Patient and public involvement/engagement: The investigators received feedback from patients and family members which helped to design this proposal, the lay summary and what to measure in a trial. Patients and family members will continue to help with development of the sedation and trial protocol. 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
Official Title
Improving Sedation Practice in Critically Ill Adult Patients Using a Co-designed Sedation Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years and older
- Receiving continuous intravenous infusions of analgosedation (opioids, benzodiazepines, and/or propofol)
- Receiving ECMO for moderate to severe respiratory failure (PaO2/FiO2 ratio < 20 kilopascals) for 7 days or less during the week of recruitment
- Non-ECMO ICU patients must meet the above age and sedation criteria and have received mechanical ventilation for at least 48 hours for moderate to severe respiratory failure or for a cardiovascular disorder
- Healthcare professionals working at St Thomas' Hospital or Royal Brompton Hospital ECMO centres
- ECMO survivors who have returned home and recovered
- Family members of ECMO survivors whose relative is no longer hospitalized
You will not qualify if you...
- Expected ICU stay of less than 24 hours at the recruiting centre
- Withdrawal of life-sustaining treatment expected within the next 24 hours
- ECMO survivors currently receiving treatment in hospital
- ECMO survivors with severe cognitive problems affecting memory or thinking
- ECMO survivors unable to communicate in English
- Non-ECMO survivors and their family members
AI-Screening
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Trial Site Locations
Total: 1 location
1
Guy's and St Thomas' NHS Foundation Trust
London, London, United Kingdom, SE1 7EH
Actively Recruiting
Research Team
C
Christopher Remmington, MPharm
CONTACT
L
Louise Rose, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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