Acute Heart Failure, Acute Respiratory Failure, Cardiac Arrest, Critically Ill
Conditions
Keywords
Intensive Care, Critical Care, Extracorporeal Membrane Oxygenation, Extracorporeal Life Support
Brief summary
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
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.
Interventions
None listed
Sponsors
National Health and Medical Research Council, Australia
Extracorporeal Life Support Organization
National Heart Foundation, Australia
The Alfred
Barwon Health
Fiona Stanley Hospital
The Prince Charles Hospital
Royal Prince Alfred Hospital, Sydney, Australia
St Vincent's Hospital, Sydney
Australian and New Zealand Intensive Care Research Centre
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients admitted to adult hospitals and receive ECMO in Australia and New Zealand Nil
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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%. | At 6 months from study enrolment | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 28 days after ECMO initiation | All adverse events are recorded determined by treating clinician |
| Healthcare utilization - caseload per centre | Up to 12 months from study enrolment | ECMO patient numbers (caseload per centre) |
| Healthcare utilization - number of staff members required to manage ECMO | Up to 12 months from study enrolment | Staff numbers required for the provision of ECMO in ICU and the training required for these staff members to perform their role. |
| Healthcare utilization - hospital length of stay | Up to 12 months from study enrolment | Hospital and in-patient rehabilitation length of stay including hospital readmissions and time spent in ICU |
| Healthcare costs | Measured from ECMO commencement to hospital discharge until 6 months following hopsital admission. | Number of resources including staff and, equipment and blood products utilised whilst the patient was receiving hospital care until 6 months following hospital admission. |
| Health-related quality of life at baseline, 6 and 12 months using the EQ5D-5L | At 6 and 12 months from study enrolment. Retrospective baseline measured at 6 months. | 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) |
| Healthcare utilization - ECMO initiation timing | Up to 12 months from study enrolment | Timing of ECMO initiation by staff including an ECMO retrieval team |
| Psychological function at 12 months | At 12 months from study enrolment | Measured using the EQ5D-5L, delivered by a trained, blinded assessor via telephone interview |
| Return to work at 6 months | At 6 months from study enrolment | Return to work measured bu the WHODAS 2.0, delivered by a trained, blinded assessor via telephone interview |
| Disability at baseline, 6 and 12 months | Measured at 6 and 12 months. Retrospective baseline disability measured at 6 months. | Patient reported disability using a disability scale, delivered by a trained, blinded assessor via telephone interview |
| Activities of daily living at 6 and 12 months | Measured 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 |
| Cognitive function at 12 months | Measured at 12 months | Cognitive function measured at 12 months using the MOCA Blind, delivered by a trained, blinded assessor via telephone interview |
| Number patients who survive to 12 months following ECMO initiation | At 12 months from study enrolment | Measured by Research Coordinators at each of the participating sites |
| Number of patients with disability at 6 and 12 months | At 6 and 12 months from study enrolment | Measured using the WHODAS 2.0, delivered by a trained, blinded assessor via telephone interview |
Countries
Australia, New Zealand
Contacts
Primary ContactCarol L Hodgson, PhD
Backup ContactBen Fulcher
Outcome results
None listed