重症监护中身体成分的超声检测
超声检测危重产科身体成分变化及其与临床结果的相关性;前瞻性观察研究。
研究概览
详细说明
患有急性/危重疾病的患者特别容易出现肌肉损失和体液转移,这会对临床结果产生不利影响。 在医院环境中对这些参数的评估通常是主观且不精确的,这导致识别上的差异和后续的困难。
肌肉质量的减少和/或成分的变化以及液体超负荷会对危重患者的临床结果及其康复产生不利影响。 人们对可应用于 ICU 环境的身体成分 (BC) 评估技术越来越感兴趣。 全身 BC 估计和选择 BC 变量有望作为肌肉健康、营养风险和液体状态的生物标志物。 研究报告称,股四头肌厚度可预测 ICU 患者发病率/死亡率的增加,并被认为是确定是否适合积极治疗的客观生物标志物。 美国对重症患者肌肉损失的测量将有助于制定适当的干预策略。 或者,通过测量回声性(使用图像灰度视觉分析)进行定性肌肉评估是肌肉萎缩的敏感指标。 超声可以代替危重患者的侵入性肌肉活检来评估坏死、脂肪浸润和炎症。 超声为危重病人肌肉功能的早期非意志评估提供了重要工具。
美国对肌肉变化的描述将有助于开发和监测针对肌肉的营养和物理治疗干预措施。 在多种临床情况下,了解身体肌肉和脂肪组织质量至关重要,以便根据分布体积调整药物剂量并指导营养和物理治疗。 US 成像是前瞻性评估 SM(骨骼肌)因疾病和治疗而发生的变化的实用方法。 之前的 ICU 研究重点是测量股四头肌的肌肉数量(肌肉厚度和 CSA),股四头肌是已知会迅速受到肌少症影响的肌肉区域,并且与 ICU 存活率相关。 超声波主要用作临床营养中身体成分测量的工具。 尽管最近的许多报告表明超声可能是营养评估和身体成分评估的有用工具,但它并没有很好地融入到 ICU 营养评估和随访实践中。这项试验是第一个研究超声在检测身体中的作用的试验。妇产科危重病例的构成及其与临床结果的相关性。
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:wessam selima, MD
- 电话号码:01001958858
- 邮箱:w.z.selima@gmail.com
学习地点
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Cairo Governorate
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Cairo、Cairo Governorate、埃及、11528
- 招聘中
- Ain Shams University
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接触:
- Anesthesia department
- 电话号码:010009499962
- 邮箱:anesth_office@med.asu.edu.eg
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
纳入标准:
- 16岁以下女性,无上限
- 美国麻醉医师协会 (ASA) I、II 或 III 级,
- 住进妇产科重症监护室
排除标准:
- 病人拒绝
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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入住ICU的危重产科患者
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Muscle mass and fat thickness assessed at two representative sites (rectus femoris, biceps brachii) per USVALID (Arabella, 2020).
Muscle quality graded via validated 4-point Heckmatt echogenicity scale (Grade 1=normal, Grade 4=severe; full criteria in Outcome Measures).Subcutaneous fat thickness(mm) measured on rectus femoris.
FLUID protocol for oedema: 36-site USEG 5-point scale .
Day 0, day 2, then every 2 days untill at in-stay deterioration or death or discharge.
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妇科危重病例,入住ICU
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Muscle mass and fat thickness assessed at two representative sites (rectus femoris, biceps brachii) per USVALID (Arabella, 2020).
Muscle quality graded via validated 4-point Heckmatt echogenicity scale (Grade 1=normal, Grade 4=severe; full criteria in Outcome Measures).Subcutaneous fat thickness(mm) measured on rectus femoris.
FLUID protocol for oedema: 36-site USEG 5-point scale .
Day 0, day 2, then every 2 days untill at in-stay deterioration or death or discharge.
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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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change in body composition-muscular element
大体时间:on the day of admission , repeated every 2 days till death or discharge which come first, assessed up to 20 days from admission
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Change in muscle thickness (mm) and change in muscle quality, assessed by ultrasound echogenicity at two representative sites: rectus femoris (lower limb) and biceps brachii (upper limb).
Muscle quality is graded using the validated four-point Heckmatt scale: Grade 1 = normal echogenicity with distinct bone reflection; Grade 2 = increased echogenicity with preserved architecture and normal bone reflection; Grade 3 = further increased echogenicity with some loss of architecture and reduced bone reflection; Grade 4 = markedly increased echogenicity with total loss of architecture and absent bone reflection.
A derived ordinal muscle severity category is calculated from the highest grade observed across the two sites.
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on the day of admission , repeated every 2 days till death or discharge which come first, assessed up to 20 days from admission
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change in body composition-fat element
大体时间:on the day of admission , repeated every 2 days till death or discharge which come first, assessed up to 20 days from admission.
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change in thickness of subcutaneous fat measured in mm.
A derived categorical adiposity classification (low, normal, or high adipose reserve) is also calculated from this measurement.
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on the day of admission , repeated every 2 days till death or discharge which come first, assessed up to 20 days from admission.
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change in body composition-extreacellular oedema element
大体时间:on the day of admission , repeated every 2 days till death or discharge which come first .
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The examiner will use a 5-point scale of ultrasonic subcutaneous edema grade (USEG) to evaluate subcutaneous edema at each site based on echo intensity, tissue transparency, and fluid properties.
The final ultrasonic subcutaneous edema score (USES) is calculated by adding scores from 36 subcutaneous sites (0-144), regionally grouped: hands (0-8), arms (0-16), thoracic wall (0-32), abdominal wall (0-32), thigh (0-24), calves (0-24), feet (0-8), with regional totals averaged to a 0-4 score per region.
Lower scores indicate lower oedema severity.
A derived categorical oedema severity classification is also calculated from the total score.
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on the day of admission , repeated every 2 days till death or discharge which come first .
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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co-relation of the change of any elements of body composition with poor outcomes suchs such as death, need for ventilatory or circulatory support or increase the length of stay in icu.
大体时间:from occurence of change in body composition till the poor outcome. till discharge from icu or death which come first, assessed till 20 days from admission
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Positive or negative correlation between change in any body composition element (muscular, fat, extracellular oedema) and poor clinical outcomes, measured by frequency of occurrence of poor outcomes in patients with positive change in any element.
The muscle, oedema, and adiposity classifications above are combined into a single five-category bedside phenotype (Resilient, Vulnerable, Oedematous, Metabolically Compromised, Extreme Metabolic Risk), assessed at admission and at the point of in-stay deterioration; this composite phenotype is the primary exposure examined against outcome.
Poor outcome is defined as a composite of mortality, need for ventilatory support, or need for circulatory support.
ICU length of stay is analyzed separately as a continuous outcome.
Additional outcomes recorded include failed extubation, need for renal replacement therapy, and need for blood transfusion
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from occurence of change in body composition till the poor outcome. till discharge from icu or death which come first, assessed till 20 days from admission
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合作者和调查者
出版物和有用的链接
一般刊物
- Gursoy C, Alkan A, Kaya Cubuk E, Karci E, Yilmaz HO, Cakir T. Rectus abdominis and rectus femoris muscle thickness in determining nutritional risk in critically ill patients: a prospective cohort study in Turkey. BMJ Open. 2023 Mar 30;13(3):e071796. doi: 10.1136/bmjopen-2023-071796.
- Ponti F, De Cinque A, Fazio N, Napoli A, Guglielmi G, Bazzocchi A. Ultrasound imaging, a stethoscope for body composition assessment. Quant Imaging Med Surg. 2020 Aug;10(8):1699-1722. doi: 10.21037/qims-19-1048.
- Zhang W, Gu Y, Zhao Y, Lian J, Zeng Q, Wang X, Wu J, Gu Q; Chinese Critical Care Ultrasound Study Group (CCUSG). Focused liquid ultrasonography in dropsy protocol for quantitative assessment of subcutaneous edema. Crit Care. 2023 Mar 18;27(1):114. doi: 10.1186/s13054-023-04403-y.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
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
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- FMASU R149/2024
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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