Actively Recruiting

Age: 18Years - 100Years
All Genders
ID07032987

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

N/A

Total Duration

On this page

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: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1

Guy's and St Thomas' NHS Foundation Trust

London, London, United Kingdom, SE1 7EH

Actively Recruiting

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Research Team

C

Christopher Remmington, MPharm

L

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

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Published Research Related To This Trial

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...

https://pubmed.ncbi.nlm.nih.gov/29498938

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...

https://pubmed.ncbi.nlm.nih.gov/30113379

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...

https://pubmed.ncbi.nlm.nih.gov/27538536