Co-designed pain and sedation protocol for adults on ECMO

Optimising Analgosedation in Extracorporeal Membrane Oxygenation (ECMO) Using a Co-designed Analgosedation Protocol

This project will test a co-designed pain and sedation plan to see if it's acceptable for adults receiving ECMO and similar ventilated ICU patients.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Guy's and St Thomas' NHS Foundation Trust (Academic / other)
• Locations: 1 site (London, London)
• Trial ID: NCT07032987 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults (18+) in UK ICUs receiving continuous IV analgosedation who are on ECMO for moderate to severe respiratory failure, with a representative control group of mechanically ventilated non-ECMO patients.

Not a fit: Patients expected to stay in ICU less than 24 hours, those with planned withdrawal of life-sustaining treatment, children, or patients not receiving continuous IV analgosedation are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, the protocol could help staff give the right amount of sedation, reducing delirium, drug withdrawal, and time in hospital for ECMO patients.

How similar studies have performed: Sedation protocols in general ICU populations have shown benefits in reducing over-sedation and length of stay, but formal co-designed analgosedation protocols specific to ECMO patients are less tested and relatively novel.

Eligibility criteria

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 this trial is running

London, London

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

Study contacts

• Study coordinator: Christopher Remmington, MPharm

Conditions Intensive Care Medicine; Respiratory Distress Syndrome; Sedation and Analgesia; ExtraCorporeal Membrane Oxygenation; Sedation for Mechanical Ventilation; Cardiogenic Shock; Opioid Analgesia; Analgesia