Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients
Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients: A Prospective Observational Study
Muscle wasting is a significant problem in critically ill patients, with reported losses of a half to three percent per day over the first ten days (for an average 70kg person this equates to 3 to 20kg of muscle loss). Low skeletal muscle mass at admission to the intensive care unit (ICU) and the loss of lean tissue have been associated with negative clinical outcomes, including increased incidence of infections, length of stay, mortality and muscle weakness. It is therefore crucial that technology is utilised to: 1) identify ICU patients with low muscularity on admission, 2) to help understand the factors impacting muscle loss and to 3) assess the effectiveness of interventions aimed at maintaining skeletal muscle mass in this population.
The measurement of lean body mass in patients admitted to the ICU is challenging however, due to the large fluid shifts that occur in this population and logistical issues in moving patients to specialised machinery for body composition analysis. Currently, there is no validated method for accurately assessing a patient's muscle mass at the bedside in the intensive care setting. It is therefore important to investigate the accuracy, feasibility and reliability of bedside methods such as subjective physical assessment of muscle mass, mid arm muscle circumference, ultrasound and bioimpedance analysis to assess muscularity in this population who are primarily bedbound. In order to do this, a critical comparison is required between these methods and muscularity assessed by a "reference" body composition method, such computed tomography (CT) image analysis. Briefly, quantification of skeletal muscle at the abdomen area utilising abdominal CT images has been shown to be highly representative of whole body skeletal muscle volume.
We wish to conduct a pilot, feasibility study (n= 50), which will recruit patients who have a CT scan (containing abdomen area), performed for clinical purposes. Our primary aim will be to investigate whether muscularity assessed with non-invasive bedside methods (ultrasound, bioimpedance analysis, SGA physical assessment, mid arm muscle circumference) are correlated with skeletal muscle mass quantified by a "reference method" (CT image analysis).
研究概览
详细说明
Aim Our primary aim is to investigate whether muscularity assessed via bedside ultrasound is correlated with a reference method for estimating whole body skeletal muscle mass (CT image analysis) in the first few days of critical illness.
Our secondary aims are
- To investigate whether muscularity assessed via other bedside methods (bioimpedance spectroscopy, subjective physical assessment and mid arm muscle circumference) are correlated with a reference method for estimating whole body skeletal muscle mass (CT image analysis) in critically ill patients.
- To better understand the association between measured resting energy expenditure and muscularity in the critically ill.
- To observe changes in skeletal muscle mass (in a sub set of patients who have two CT scans) and the impact various factors, including energy and protein delivery has on these changes.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Victoria
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Melbourne、Victoria、澳大利亚、3004
- The Alfred Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Have had a CT scan of the L3 vertebra performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
Exclusion Criteria:
- CT scan performed >48hrs ago
- Death is imminent or deemed highly likely in the next 96 hours
- Are known to be pregnant
- Treating clinician does not believe the study to be in the best interest of the patient
- It is not possible to image two or more muscle groups via ultrasound (i.e. due to trauma, burns, wounds)
学习计划
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 |
大体时间 |
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Mean skeletal muscle mass measured by CT scan analysis at L3 area (cm2)
大体时间:CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
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CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
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Mean skeletal muscle mass measured by ultrasound (muscle thickness at each site, cm and rectus femoris CSA, cm2)
大体时间:<48 hours after CT scan containing L3 area
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<48 hours after CT scan containing L3 area
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次要结果测量
结果测量 |
大体时间 |
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Fat free mass (kg), phase angle and impedance ratio measured by bioimpedance spectroscopy
大体时间:<48 hours after CT scan containing L3 area
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<48 hours after CT scan containing L3 area
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Subjective assessment of muscle and fat wasting via SGA (normal, mild-moderate or severe)
大体时间:<48 hours after CT scan containing L3 area
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<48 hours after CT scan containing L3 area
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Mid arm muscle circumference (cm)
大体时间:<48 hours after CT scan containing L3 area
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<48 hours after CT scan containing L3 area
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Mean skeletal muscle mass measured by CT scan analysis at femoral area (cm2)
大体时间:CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
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CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
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Measured resting energy expenditure (kilojoules)
大体时间:<48 hours after CT scan containing L3 area
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<48 hours after CT scan containing L3 area
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Intramuscular, subcutaneous and visceral adipose tissue CSA at L3 area (cm2)
大体时间:CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
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CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
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合作者和调查者
合作者
调查人员
- 首席研究员:Kate Lambell, MNutrDiet、La Trobe University and Alfred Health
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Observational cohort的临床试验
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SENAI CIMATEC招聘中
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Bristol-Myers SquibbCardioxyl Pharmaceuticals, Inc完全的