Co-designed pain and sedation protocol for adults on ECMO

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-centre observational cohort will describe current opioid and sedative use, dosing, and assessment in adult ECMO patients and a representative sample of non-ECMO ICU patients across UK ECMO centres. Investigators will record analgosedation practices and patient outcomes including ICU mortality, length of stay, and delirium incidence. Data and stakeholder input will be used to co-design an analgosedation protocol with patients, carers, and staff and to determine clinical equipoise for a future feasibility cluster randomized trial. A second, mixed-methods stage will test the anticipatory acceptability of the co-designed protocol with healthcare professionals and patients.

Why it matters

Who can join: the full rules

Stage 1 (multi-centre observational study):

Inclusion Criteria:

1. Aged 18 years and older.
2. Receiving continuous IV infusions of analgosedation (opioids, benzodiazepines, and/or propofol).
3. Receiving ECMO for moderate to severe respiratory failure (PaO2/FiO2 (P/F) ratio \<20 kilopascals (kPa)) for ≤ 7 days during the week of recruitment.
4. Non-ECMO ICU patients (control group): must satisfy inclusion criteria 1 and 2, and have received mechanical ventilation for moderate to severe respiratory failure (P/F ratio \< 20kPa) for at least 48 hours OR mechanical ventilation for cardiovascular disorder (out of hospital cardiac arrest, following cardiothoracic or transplant surgery or percutaneous coronary intervention or acute heart failure).

Exclusion Criteria:

1. Anticipated length of ICU stay in recruiting centre for less than 24 hours.
2. Withdrawal of life-sustaining treatment in the next 24 hours.

Stage 2 (mixed methods study):

Inclusion Criteria:

1. Healthcare professionals working at one of two ECMO centres (St Thomas' Hospital and Royal Brompton Hospital (part of Guy's and St Thomas' NHS Foundation Trust).
2. ECMO survivors (patients admitted to ICU and survived ECMO organ support) who have returned home, and recovered.
3. Family members of ECMO survivors, whose relative is no longer hospitalised.

Exclusion Criteria:

1. ECMO survivors currently receiving treatment in hospital.
2. ECMO survivors with severe cognitive issues (issues with short-term memory and thinking).
3. ECMO survivors who cannot communicate in English.
4. Non-ECMO survivors and family members.

Where it's running

• Guy's and St Thomas' NHS Foundation Trust
  London, London, United Kingdom Recruiting

Study contacts

• Study coordinator: Christopher Remmington, MPharm
• Email: christopher.remmington@nhs.net
• Phone: +442078365454

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.