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临床试验/NCT03026985
NCT03026985已完成不适用

Acute Skeletal Muscle Wasting and Relation to Physical Function in Patients Requiring Extracorporeal Membrane Oxygenation (ECMO)

The Alfred1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Change in quadriceps muscle size as determined by ultrasound in patients requiring ECMO

研究概览

简要总结

The purpose of this study is to describe the changes in quadriceps muscle size and quality over the first 10 days on extracorporeal membrane oxygenation (ECMO) using ultrasound imaging. This study will also examine the relationship between those changes and muscle strength and level of physical function at day 10 and day 20 after ECMO commencement.

详细描述

The use of ECMO has increased dramatically in the past decade with improvements in technology and survival. Whilst it is a potentially life-saving intervention in a group of patients at high risk of death, it is both highly invasive and expensive. ECMO poses a dramatic physiological burden on patients with major long-term consequences. Among these, severe prolonged neuromuscular weakness is perhaps the most significant complication. Described clinically as intensive care unit acquired weakness (ICUAW), it is associated with prolonged weaning from mechanical ventilation, delayed rehabilitation, increased hospital length of stay, and mortality with residual deficits in physical functional ability persisting up to 5 years following the ICU admission. The health value, to both patients and society, could be substantially improved if more patients achieved a complete recovery.

Muscle strength testing in the early stages of critical illness is limited, as it requires the patient to be awake, alert and cognitively intact, therefore delayed diagnosis of ICUAW due to inability of patients to complete muscle strength testing is common. Consequently, there is growing interest in the utility of ultrasound imaging to monitor the trajectory of muscle wasting and inform development of targeted interventions in these critically ill patients. Ultrasound imaging of skeletal muscle is a non-invasive, painless and radiation free technique that can provide objective, accurate and reliable data on skeletal muscle in these critically ill patients. This study will use ultrasound imaging to quantify the early change in skeletal muscle size and quality, and the relationship to strength and physical function in patients on ECMO. Risk stratification of patients with peripheral muscle wasting is vital for optimising clinical management, including development of improved rehabilitative strategies to improve recovery and optimise the risk/benefit profile of ECMO.

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

入选标准

  • Adult patients (≥18 years)
  • Requiring ECMO for management of severe cardiac or respiratory failure
  • Likely to spend > 24 hours on ECMO

排除标准

  • Presence of:
  • Any connective tissue disorders (e.g., Marfan's syndrome)
  • A proven or suspected acute primary brain process that is likely to result in global impairment of conscious level or cognition, such as traumatic brain injury, intracranial haemorrhage, stroke, or hypoxic brain injury after cardiac arrest or asphyxiation
  • Any neuromuscular conditions (e.g., multiple sclerosis, muscular dystrophy, spinal cord injury, Guillain-Barre syndrome)
  • Any current cancer or chemotherapy
  • A cognitive impairment prior to the acute illness that is associated with admission to ICU that would impair capacity to follow verbal instructions Any current acute musculoskeletal injuries of hip, knee, and ankle
  • A pre-existing mobility impairment where the patient is unable to walk without assistance prior to the acute illness that is associated with admission to ICU (use of a walking stick or frame is not an exclusion)
  • A language barrier to patient comprehension, or where death is deemed imminent and inevitable

结局指标

主要结局

Change in quadriceps muscle size as determined by ultrasound in patients requiring ECMO

时间窗: 10 days

Change in quadriceps muscle size

次要结局

未报告次要终点

研究者

发起方
The Alfred
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kate Hayes

Senior Physiotherapist

The Alfred

研究点 (1)

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