The EXCEL Registry: A Comprehensive Binational Registry on the Treatment and Outcomes of Patients Requiring ECMO
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 29
- 主要终点
- 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%.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to adult hospitals and receive ECMO in Australia and New Zealand
- •Nil Exclusion Criteria
排除标准
- 未提供
结局指标
主要结局
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%.
时间窗: 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)
次要结局
- Healthcare utilization - number of staff members required to manage ECMO(Up to 12 months from study enrolment)
- Healthcare utilization - hospital length of stay(Up to 12 months from study enrolment)
- 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.)
- Healthcare utilization - ECMO initiation timing(Up to 12 months from study enrolment)
- Number of patients with disability at 6 and 12 months(At 6 and 12 months from study enrolment)
- 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)
- Healthcare utilization - caseload per centre(Up to 12 months from study enrolment)
- Healthcare costs(Measured from ECMO commencement to hospital discharge until 6 months following hopsital admission.)
- Psychological function at 12 months(At 12 months from study enrolment)
- Disability at baseline, 6 and 12 months(Measured at 6 and 12 months. Retrospective baseline disability measured at 6 months.)
- Return to work at 6 months(At 6 months from study enrolment)
- Activities of daily living at 6 and 12 months(Measured at 6 and 12 months)
- Number patients who survive to 12 months following ECMO initiation(At 12 months from study enrolment)
- Cognitive function at 12 months(Measured at 12 months)