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Optimising Analgosedation In Extracorporeal Membrane Oxygenation ECMO Using A Co-Designed Analgosedation Protocol
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Actively Recruiting
Age: 18 Years - 100 Years
All Genders
ID: 07032987
Optimising Analgosedation in Extracorporeal Membrane Oxygenation (ECMO) Using a Co-designed Analgosedation Protocol
Led by Guy's and St Thomas' NHS Foundation Trust
Updated on: 2026-05-08
120
Participants Needed
1
Research Sites
Total Duration
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AI-Summary
What This Trial Is About
Researchers are studying sedation practices for adults in intensive care units (ICU) who are receiving extracorporeal membrane oxygenation (ECMO), a life support technique for severe heart or lung failure. This research aims to describe current sedation use in ECMO patients compared to non-ECMO critically ill patients in the UK and develop a sedation protocol co-designed with patients, family members, and healthcare staff. The goal is to improve comfort and reduce long-term problems like anxiety, memory issues, and mobility difficulties seen in ECMO survivors. The study has two parts. First, an observational study will collect detailed data on sedation drugs, doses, pain and sedation scores, and patient outcomes for ECMO and non-ECMO ICU patients. This will include gathering information from multiple UK ECMO centers. In the second part, the investigators will develop a sedation protocol based on input from patients, family, and staff, then assess its acceptability and safety through interviews and questionnaires with healthcare professionals and ECMO survivors. Participants will be involved through data collection of sedation use and patient outcomes during ICU stays, and through interviews and surveys that explore the acceptability of the new sedation protocol. Researchers will monitor outcomes like ICU mortality and length of stay, as well as sedation and delirium assessments. The study will run until August 2027, with findings shared through various channels to inform future sedation practices in ECMO care.
CONDITIONS
Brief Title
Improving Sedation Practice in Critically Ill Adult Patients Using a Co-designed Sedation Protocol
Who Can Participate
Age: 18 Years - 100 Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Receiving continuous intravenous infusions of sedation drugs such as opioids, benzodiazepines, or propofol
- Receiving ECMO for moderate to severe respiratory failure with a P/F ratio below 20 kPa for 7 days or less during recruitment week
- Non-ECMO ICU patients who meet sedation criteria and have mechanical ventilation for respiratory failure or cardiovascular disorder
- Healthcare professionals working at specific ECMO centres
- ECMO survivors who have returned home and recovered
- Family members of ECMO survivors whose relative is no longer hospitalized
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You will not qualify if you...
- Expected ICU stay of less than 24 hours at recruiting centre
- Planned withdrawal of life-sustaining treatment within 24 hours
- ECMO survivors currently hospitalized
- ECMO survivors with severe cognitive problems affecting memory or thinking
- ECMO survivors unable to communicate in English
- Non-ECMO survivors and family members
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to ICU discharge, generally up to 5 days of data collection
Participants who are ECMO and non-ECMO ICU patients are observed to collect data on sedation practices, patient outcomes, and clinical parameters during their ICU stay.
Continuous monitoring during ICU stay; data collected hourly for sedative dosing over 5 days
Long-term Monitoring
Duration - Single session lasting approximately 45 minutes
ECMO survivors and their family members participate in interviews and questionnaires to assess acceptability of the co-designed analgosedation protocol after hospital discharge.
1 online interview session
Trial Site Locations
Total: 1 location
- Guy's and St Thomas' NHS Foundation Trust
- London, London, United Kingdom, SE1 7EH
Actively Recruiting
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Research Team
- Christopher Remmington, MPharm
- Louise Rose, PhD
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
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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Research Publications
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Clinician perspectives on protocols designed to minimize sedation.
- Louise Rose, Emma Fitzgerald, Deborah Cook...
- PubMed Link
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Staff perceptions on the use of a sedation protocol in the intensive care setting.
- R Louise Rose, Tracey Bucknall
- PubMed Link
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Sedation Intensity in the First 48 Hours of Mechanical Ventilation and 180-Day Mortality: A Multinational Prospective Longitudinal Cohort Study.
- Yahya Shehabi, Rinaldo Bellomo, Suhaini Kadiman...
- PubMed Link
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Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation.
- J P Kress, A S Pohlman, M F O'Connor...
- PubMed Link
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Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU.
- John W Devlin, Yoanna Skrobik, Céline Gélinas...
- PubMed Link
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Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit.
- E Wesley Ely, Ayumi Shintani, Brenda Truman...
- PubMed Link
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Analgosedation in extracorporeal membrane oxygenation: a retrospective UK cohort study.
- Christopher Remmington, Cathrine McKenzie, Luigi Camporota...
- PubMed Link
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Sedation in adults receiving mechanical ventilation: physiological and comfort outcomes.
- Mary Jo Grap, Cindy L Munro, Paul A Wetzel...
- PubMed Link
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Early deep sedation is associated with decreased in-hospital and two-year follow-up survival.
- Felix Balzer, Björn Weiß, Oliver Kumpf...
- PubMed Link
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The association of sleep quality, delirium, and sedation status with daily participation in physical therapy in the ICU.
- Biren B Kamdar, Michael P Combs, Elizabeth Colantuoni...
- PubMed Link
Sponsors
- Guy's and St Thomas' NHS Foundation Trust
- Lead Sponsor
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