The Use of Computed Tomography (CT) to Measure Skeletal Muscle Quantity and Quality in Patients Receiving ECMO
2019年2月14日 更新者：Danielle Bear、Guy's and St Thomas' NHS Foundation Trust
This is a retrospective, observational study and will investigate the clinical predictive value of and change in muscle quantity and quality in critically ill patients with severe respiratory failure requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO).
研究概览
详细说明
The use of veno-venous extra-corporeal membrane oxygenation (VV-ECMO) for severe respiratory failure - mainly hypoxaemia - has increased over recent years. Similar to the general population in the Intensive Care Unit (ICU), these patients become deconditioned, severely weak (ICU acquired weakness- ICUAW) and require prolonged rehabilitation after disconnection from VV-ECMO. However, data regarding the magnitude of muscle wasting and recovery in this specific group is lacking.
Both poor muscle quantity and quality have been found to be a predictor or poor outcome. As all patients receiving VV-ECMO at our hospital will get an initial CT scan of their chest, abdomen and pelvis, these CT scans will be used to measure muscle quantity and quality of different muscle groups of the abdomen at admission and then using any follow-up CT scan performed within 10 days. In addition, the relationship between the loss of muscle over the course of VV-ECMO and perceived recovery of renal function at ICU discharge will be investigated.
研究类型
观察性的
注册 (实际的)
215
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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London、英国、SE1 7EH
- Guy's and St Thomas' NHS Foundation Trust
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 100年 (成人、年长者)
接受健康志愿者
不适用
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Adult Critically ill patients with severe respiratory failure requiring VV-ECMO
描述
Inclusion Criteria:
- Critically ill patients with Severe Respiratory Failure who required VV-ECMO and had one or more CT scans of their abdomen
Exclusion Criteria:
- Critically ill patients with Severe Respiratory Failure who required VV-ECMO and did not have one or more CT scans of their abdomen
- Critically ill patients with Severe Respiratory Failure who required VV-ECMO who have a poor quality CT scan not analysable by the software
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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All cause mortality
大体时间：On ECMO (expected to be about 10 days)
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Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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On ECMO (expected to be about 10 days)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Length of ECMO duration
大体时间：The total duration on ECMO (expected to be an average of 10 days)
|
Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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The total duration on ECMO (expected to be an average of 10 days)
|
|
Length of ICU admission
大体时间：The total duration of ICU admission (expected to be around 2 weeks)
|
Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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The total duration of ICU admission (expected to be around 2 weeks)
|
|
Length of hospital stay
大体时间：The total duration of hospital admission (expected to be around 28 days)
|
Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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The total duration of hospital admission (expected to be around 28 days)
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Length of ventilation
大体时间：Total duration of mechanical ventilation during intensive care unit stay (expected to be around 10 days)
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Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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Total duration of mechanical ventilation during intensive care unit stay (expected to be around 10 days)
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Discharge destination
大体时间：After discharge from hospital (expected to be around 28 days)
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Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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After discharge from hospital (expected to be around 28 days)
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Sequential changes in the muscle quantity over time
大体时间：The total duration of ECMO (expected to be around 10 days)
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Using total muscle quantity measured from CT slice of the third lumbar region.
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The total duration of ECMO (expected to be around 10 days)
|
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Sequential changes in muscle quality over time
大体时间：The total duration of ECMO (expected to be around 10 days)
|
Using total muscle quality measured from CT slice of the third lumbar region.
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The total duration of ECMO (expected to be around 10 days)
|
|
Relationship between muscle loss and total nutrition received
大体时间：The total duration of ECMO (expected to be around 10 days)
|
Using total muscle quantity measured from CT slice of the third lumbar region.
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The total duration of ECMO (expected to be around 10 days)
|
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Relationship between muscle loss and rehabilitation goals met
大体时间：The total duration of ECMO (expected to be around 10 days)
|
Using total muscle quantity measured from CT slice of the third lumbar region.
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The total duration of ECMO (expected to be around 10 days)
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All cause mortality
大体时间：Intensive Care Unit Stay (expected to be about 2 weeks)
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Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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Intensive Care Unit Stay (expected to be about 2 weeks)
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All cause mortality
大体时间：6 months post-ICU discharge
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Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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6 months post-ICU discharge
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All cause mortality
大体时间：Hospital discharge (expected to be about 28 days)
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Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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Hospital discharge (expected to be about 28 days)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Danielle E Bear, MRes、Guy's and St Thomas' NHS Foundation Trust
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年6月20日
初级完成 (实际的)
2018年5月31日
研究完成 (实际的)
2018年5月31日
研究注册日期
首次提交
2017年6月23日
首先提交符合 QC 标准的
2017年8月29日
首次发布 (实际的)
2017年9月1日
研究记录更新
最后更新发布 (实际的)
2019年2月15日
上次提交的符合 QC 标准的更新
2019年2月14日
最后验证
2019年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.