The EXCEL Registry of Patients Requiring ECMO

The aim of EXCEL is to generate a bi-national multidisciplinary network of integrated care for patients suffering acute cardiac or respiratory failure or cardiac arrest requiring extracorporeal membrane oxygenation (ECMO) to monitor long term outcomes and identify best practice.

Each year around 130,000 Australians and New Zealanders are admitted to an intensive care unit (ICU). The sickest patients in the ICU who have severe failure of the heart or lungs may require an external machine to oxygenate their blood in addition to a mechanical ventilator. This intervention, called extracorporeal membrane oxygenation (ECMO), involves circulating all of the patient's blood through large cannulae to external machinery every minute. It has the capability of completely replacing a non-functioning heart or lungs for days to weeks on end. These critically ill patients who require ECMO are the sickest in the hospital with only 42% hospital survival. The use of ECMO has doubled in Australia and New Zealand and globally over five years, and in the USA has increased by 433%.

The use of ECMO is associated with significant costs and risks, and it requires specialist training and expertise. In order to prepare for the organisation of these complex interventions in the ICU across regions, the investigators need to have accurate data on patients undergoing ECMO. The investigators monitor and review current practice in ECMO services by providing robust binational registry data to service providers and clinicians with a closed-loop feedback system. EXCEL explores barriers and enablers to evidence-based care in ECMO services and providing a platform to embed clinical trials. The investigators will translate findings with greater capacity, reach, and impact to drive measureable change in practice and improve patient-centred outcomes.

The EXCEL Partnership represents a novel, coordinated effort to create a high-quality, detailed, prospective registry of patients requiring ECMO at ECMO centres. A tailored, detailed ECMO registry (EXCEL) can be used to address specific safety concerns, clinical questions and process of care issues. As a result, EXCEL can be designed and implemented to answer new investigator-initiated, hypothesis-driven clinical questions.

• Number of participants with adverse events including major bleeding up to 28 days after ECMO, infection, thrombosis (in the ECMO cannulae or in the patient) and limb ischaemia [Time frame: Up to 28 days after ECMO initiation]
• Healthcare utilization - caseload per centre [Time frame: Up to 12 months from study enrolment]
• Healthcare utilization - ECMO initiation timing [Time frame: Up to 12 months from study enrolment]
• Healthcare utilization - number of staff members required to manage ECMO [Time frame: Up to 12 months from study enrolment]
• Healthcare utilization - hospital length of stay [Time frame: Up to 12 months from study enrolment]
• Healthcare costs [Time frame: Measured from ECMO commencement to hospital discharge until 6 months following hopsital admission.]
• Health-related quality of life at baseline, 6 and 12 months using the EQ5D-5L [Time frame: At 6 and 12 months from study enrolment. Retrospective baseline measured at 6 months.]
• Number of patients with disability at 6 and 12 months [Time frame: At 6 and 12 months from study enrolment]
• Psychological function at 12 months [Time frame: At 12 months from study enrolment]
• Return to work at 6 months [Time frame: At 6 months from study enrolment]
• Disability at baseline, 6 and 12 months [Time frame: Measured at 6 and 12 months. Retrospective baseline disability measured at 6 months.]
• Activities of daily living at 6 and 12 months [Time frame: Measured at 6 and 12 months]