Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation
2021年4月12日 更新者：Maria Natividad Seisdedos Nunez、Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation: an Observational Cohort Study
Little is known about the physical function outcomes in patients with severe COVID-19 patients who are admitted to Intensive Care Unit (ICU) for invasive mechanical ventilation.
The purpose of this study is to evaluate the short-term impact on physical function before hospital discharge in subjects with severe COVID-19 who have survived ICU admission for invasive mechanical ventilation.
研究概览
详细说明
DESIGN: An observation cohort study conducted in a tertiary hospital.
METHODS: Data will be collected from patients along the ICU-hospital discharge continuum, will be analysed and non-parametric tests will be used to explore association between variables.
Outcome measures: Muscle strength, as a component of physical function, will be evaluated with the Medical Research Council sum score (MRC- SS) at discharge from ICU and at hospital discharge; the Functional Status Score for the ICU (FSS-ICU) will also be assessed at hospital discharge. Data on participants' demographics, ICU admission and hospital admission will also be collected.
SIGNIFICANCE OF THE RESEARCH: Understanding how physical function is affected in patients with severe COVID-19 may help develop future prevention, therapeutic and follow-up strategies that improve quality of care and outcomes in this specific group of patients. Findings from this study may be useful to design future larger cohort studies and experimental trials.
研究类型
观察性的
注册 (实际的)
71
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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Madrid、西班牙、28034
- Medical ICU. Hospital Universitario Ramón y Cajal
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Madrid、西班牙、28034
- Surgical ICU. Hospital Universitario Ramón y Cajal
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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 80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
Subjects diagnosed with COVID-19 who require admission to the ICU for invasive mechanical ventilation.
描述
Inclusion Criteria:
- subjects diagnosed with COVID-19 who have required admission to ICU for invasive mechanical ventilation;
- have received invasive ventilation > 24 hours;
- have been successfully weaned from mechanical ventilation > 48 hours;
- were independently able to mobilise prior to current hospital admission (this includes subjects who used a walking stick or another gait aid to mobilise.
Exclusion Criteria:
- subjects or proxies with inability to communicate in Spanish fluently;
- cognitive impairment prior to ICU admission;
- proven neurological impairment or neuromuscular disorder;
- Cerebrovascular Accident during hospital stay;
- previous organ transplant;
- pregnancy;
- unstable fractures or any other injuries that would require medical bed rest.
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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Medical Research Council sum score (MRC- SS).
大体时间：< 48 hours before ICU discharge
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Physical examination will be performed to carry out manual muscle testing of strength in 6 different muscle groups of the upper limb and lower limb on both sides of the body.
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< 48 hours before ICU discharge
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Medical Research Council sum score (MRC- SS).
大体时间：< 24 hours before hospital discharge
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Physical examination will be performed to carry out manual muscle testing of strength in 6 different muscle groups of the upper limb and lower limb on both sides of the body.
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< 24 hours before hospital discharge
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The Functional Status Score for the ICU (FSS-ICU)
大体时间：< 24 hours before hospital discharge
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The Functional Status Score for the ICU (FSS-ICU) will be used to evaluate 5 functional tasks.
Each task is evaluated using an 8-point ordinal scale ranging from 0 (not able to perform) to 7 (complete independence).The total FSS-ICU score ranges from 0 to 35, with higher scores indicating better physical functioning.
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< 24 hours before hospital discharge
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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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Age
大体时间：Through study completion, up to 6 months
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Age in years
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Through study completion, up to 6 months
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Sex
大体时间：Throughout study completion , up to 6 month
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Male vs Female
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Throughout study completion , up to 6 month
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Body Mass Index
大体时间：Throughout study completion, up to 6 months
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kg/m2
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Throughout study completion, up to 6 months
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Baseline mobility
大体时间：First day the patient can cooperate with assessment according to the ' 5 Standard Questions' test.
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Baseline mobility
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First day the patient can cooperate with assessment according to the ' 5 Standard Questions' test.
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APACHE II score
大体时间：<24 hours after ICU admission
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Acute Physiology and Chronic Health Evaluation II score.The APACHE II score ranges from 0 to 71 points.
Higher scores correspond to more severe disease and a higher risk of death.
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<24 hours after ICU admission
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Length of stay in ICU
大体时间：Throughout the study completion, up to 6 months
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Number of days of stay in ICU
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Throughout the study completion, up to 6 months
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Number of days on mechanical ventilation
大体时间：Throughout the study completion, up to 6 months
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Number of days on mechanical ventilation
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Throughout the study completion, up to 6 months
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Polyneuropathy diagnosis
大体时间：Throughout the study completion, up to 6 months
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Clinical or EMG polyneuropathy diagnosis confirmation
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Throughout the study completion, up to 6 months
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Number of days on Neuromuscular Blockers
大体时间：Throughout the study completion, up to 6 months
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Number of days on NMB during mechanical ventilation
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Throughout the study completion, up to 6 months
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Episodes of prone positioning
大体时间：Throughout the study completion, up to 6 months
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Number of prone positioning episodes during ICU stay
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Throughout the study completion, up to 6 months
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Length of stay in hospital
大体时间：Throughout the study completion, up to 6 months
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Total number of days admitted to hospital
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Throughout the study completion, up to 6 months
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Continuation of care
大体时间：Throughout the study completion, up to 6 months
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Home with no follow-up physiotherapy, home with domiciliary or out-patient physiotherapy, rehabilitation facility, care home, transfer to another acute hospital.
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Throughout the study completion, up to 6 months
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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。
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)
2020年5月15日
初级完成 (实际的)
2021年2月25日
研究完成 (实际的)
2021年3月1日
研究注册日期
首次提交
2020年5月20日
首先提交符合 QC 标准的
2020年5月21日
首次发布 (实际的)
2020年5月22日
研究记录更新
最后更新发布 (实际的)
2021年4月13日
上次提交的符合 QC 标准的更新
2021年4月12日
最后验证
2021年4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.
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