Optimising analgosedation in extracorporeal membrane oxygenation using a co-designed protocol: Feasibility and acceptability of a cluster randomised controlled trial

Background Analgosedation is commonly administered to intensive care unit (ICU) patients receiving extracorporeal membrane oxygenation (ECMO) to control pain, minimise distress and discomfort. There are no international guidelines to support how to use analgosedation in ECMO patients. An analgosedation protocol guides how much analgosedation 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 longer time in hospital.

The use of an analgosedation protocol in non-ECMO ICU patients has been shown to reduce these complications, and we hope to replicate this in ECMO patients.

Research questions What are the current UK practices of analgosedation management including use of protocolised approach in adults receiving ECMO as compared to those used in non-ECMO ICU patients? Is a co-designed protocol to optimise analgosedation in adult ECMO patients acceptable to key stakeholders?

Is a cluster randomised controlled trial (cRCT) of the co-designed analgosedation protocol for adult ECMO patients feasible?

Overall aim My overall aim is to develop a co-designed analgosedation protocol for adult ECMO patients, and test its acceptability with staff and patients, and its feasibility using a cRCT design. Objectives To explore current analgosedation management in ECMO and non-ECMO ICU patients. To evaluate whether a co-designed analgosedation protocol is acceptable and safe.

To develop and evaluate the feasibility and acceptability of an analgosedation protocol in a cRCT design. Methods Study 1: A prospective cohort study of analgosedation practices across 10 UK ECMO centres.

I will collect data on analgosedation doses and availability and utilisation of analgosedation protocols in ECMO and non-ECMO ICU patients.

I will collect patient outcomes including length of mechanical ventilation and ICU stay, incidence of delirium, and ICU mortality.

Study 2: A mixed methods study to develop an analgosedation protocol with staff, patients and family, that is acceptable and safe. I will organise co-design meetings with stakeholders to develop the protocol. I will conduct semi-structured interviews to assess perceived acceptablity and safety.

Study 3: A feasibility cRCT, to understand whether the trial design is feasible in terms of protocol adherence and acceptability, delivery of the intervention as planned, and collect outcome data.

Each ECMO centre will be randomised to a co-designed analgosedation protocol intervention or usual care in two ECMO centres.

Timelines for delivery 09/2024 - Obtain study approvals 03/2025 - Publication 1: Multicentre cohort study 06/2025 - PhD upgrade assessment 07/2025 - Publication 2: Acceptability of the co-designed analgosedation protocol in ECMO patients 03/2027 - Publication 3: Feasibility and acceptability of a cluster randomised control trial 08/2027 - Thesis submission Anticipated impact/ dissemination The proposed studies will develop and evaluate the feasibility and acceptability using a analgosedation protocol, which has the potential to improve patient outcomes.

Results will be published in high impact journals, presented at international conferences, and shared via network organisations, patient charities, and social media.

Following completion of the future cRCT, I will develop national guidelines with professional societies on protocolised analgosedation management in ECMO patients.