The EXCEL Registry of Patients Requiring ECMO

Study Overview
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Brief Summary
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ECMO is associated with significant costs, risks and requires specialist training and expertise. EXCEL is a novel, high-quality, detailed prospective registry of patients requiring ECMO in Australia and New Zealand. The registry provides information on patient selection, complications, costs and patient reported outcome measures. EXCEL uses the Theoretical Domains Framework to identify evidence-practice gaps and explore barriers and enablers to tailor implementation of evidence

Detailed Description
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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.

Official Title
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The EXCEL Registry: A Comprehensive Binational Registry on the Treatment and Outcomes of Patients Requiring ECMO

Conditions
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Critically Ill, Acute Respiratory Failure, Acute Heart Failure, Cardiac Arrest

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to adult hospitals and receive ECMO in Australia and New Zealand Nil Exclusion Criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability-free survival at 6 months, defined as alive and free of disability, measured with the World Health Organisation's Disability Assessment Schedule (WHODAS 2.0) score of <25%. | WHODAS 2.0 measured using a trained, blinded assessor via telephone interview. The WHODAS scores are calculated using the sum of the six domain scores. These domain scores are then converted to a metric score ranging from 0 to 100 (where 0= no disability; 100= full disability) | At 6 months from study enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | All adverse events are recorded determined by treating clinician | Up to 28 days after ECMO initiation | 
| Healthcare utilization - caseload per centre | ECMO patient numbers (caseload per centre) | Up to 12 months from study enrolment | 
| Healthcare utilization - ECMO initiation timing | Timing of ECMO initiation by staff including an ECMO retrieval team | Up to 12 months from study enrolment | 
| Healthcare utilization - number of staff members required to manage ECMO | Staff numbers required for the provision of ECMO in ICU and the training required for these staff members to perform their role. | Up to 12 months from study enrolment | 
| Healthcare utilization - hospital length of stay | Hospital and in-patient rehabilitation length of stay including hospital readmissions and time spent in ICU | Up to 12 months from study enrolment | 
| Healthcare costs | Number of resources including staff and, equipment and blood products utilised whilst the patient was receiving hospital care until 6 months following hospital admission. | 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 | Measured using the EQ5D-5L, delivered by a trained, blinded assessor via telephone interview. The EQ5D includes an analogue scale that asks the patient to rate their health on a scale of 0 to 100. (Where 0= worst health imaginable; 100= best health imaginable) | At 6 and 12 months from study enrolment. Retrospective baseline measured at 6 months. | 
| Number of patients with disability at 6 and 12 months | Measured using the WHODAS 2.0, delivered by a trained, blinded assessor via telephone interview | At 6 and 12 months from study enrolment | 
| Psychological function at 12 months | Measured using the EQ5D-5L, delivered by a trained, blinded assessor via telephone interview | At 12 months from study enrolment | 
| Return to work at 6 months | Return to work measured bu the WHODAS 2.0, delivered by a trained, blinded assessor via telephone interview | At 6 months from study enrolment | 
| Disability at baseline, 6 and 12 months | Patient reported disability using a disability scale, delivered by a trained, blinded assessor via telephone interview | Measured at 6 and 12 months. Retrospective baseline disability measured at 6 months. | 
| Activities of daily living at 6 and 12 months | Activities of daily living measured at 6 and 12 month using the ADL and IADL, delivered by a trained, blinded assessor via telephone interview | Measured at 6 and 12 months | 
| Cognitive function at 12 months | Cognitive function measured at 12 months using the MOCA Blind, delivered by a trained, blinded assessor via telephone interview | Measured at 12 months | 
| Number patients who survive to 12 months following ECMO initiation | Measured by Research Coordinators at each of the participating sites | At 12 months from study enrolment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive Care, Critical Care, Extracorporeal Membrane Oxygenation, Extracorporeal Life Support