此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

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

地位

完全的

条件

新冠肺炎

干预/治疗

其他：Data collection and clinical testing of subjects

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)

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

西班牙
- - Madrid、西班牙、28034
    - Medical ICU. Hospital Universitario Ramón y Cajal
  - Madrid、西班牙、28034
    - Surgical ICU. Hospital Universitario Ramón y Cajal

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
Medical Research Council sum score (MRC- SS). 大体时间：< 48 hours before ICU discharge	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.	< 48 hours before ICU discharge
Medical Research Council sum score (MRC- SS). 大体时间：< 24 hours before hospital discharge	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.	< 24 hours before hospital discharge
The Functional Status Score for the ICU (FSS-ICU) 大体时间：< 24 hours before hospital discharge	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.	< 24 hours before hospital discharge

次要结果测量

结果测量	措施说明	大体时间
Age 大体时间：Through study completion, up to 6 months	Age in years	Through study completion, up to 6 months
Sex 大体时间：Throughout study completion , up to 6 month	Male vs Female	Throughout study completion , up to 6 month
Body Mass Index 大体时间：Throughout study completion, up to 6 months	kg/m2	Throughout study completion, up to 6 months
Baseline mobility 大体时间：First day the patient can cooperate with assessment according to the ' 5 Standard Questions' test.	Baseline mobility	First day the patient can cooperate with assessment according to the ' 5 Standard Questions' test.
APACHE II score 大体时间：<24 hours after ICU admission	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.	<24 hours after ICU admission
Length of stay in ICU 大体时间：Throughout the study completion, up to 6 months	Number of days of stay in ICU	Throughout the study completion, up to 6 months
Number of days on mechanical ventilation 大体时间：Throughout the study completion, up to 6 months	Number of days on mechanical ventilation	Throughout the study completion, up to 6 months
Polyneuropathy diagnosis 大体时间：Throughout the study completion, up to 6 months	Clinical or EMG polyneuropathy diagnosis confirmation	Throughout the study completion, up to 6 months
Number of days on Neuromuscular Blockers 大体时间：Throughout the study completion, up to 6 months	Number of days on NMB during mechanical ventilation	Throughout the study completion, up to 6 months
Episodes of prone positioning 大体时间：Throughout the study completion, up to 6 months	Number of prone positioning episodes during ICU stay	Throughout the study completion, up to 6 months
Length of stay in hospital 大体时间：Throughout the study completion, up to 6 months	Total number of days admitted to hospital	Throughout the study completion, up to 6 months
Continuation of care 大体时间：Throughout the study completion, up to 6 months	Home with no follow-up physiotherapy, home with domiciliary or out-patient physiotherapy, rehabilitation facility, care home, transfer to another acute hospital.	Throughout the study completion, up to 6 months

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。

赞助

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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

新冠肺炎的临床试验

University of Roma La Sapienza
Queen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention Srl

完全的

亚硫酸水治疗病毒性呼吸道疾病 (STWandRVD)

COVID-19 的急性后遗症 | COVID-19 后状况 | 长期COVID | 慢性 COVID-19 综合症

意大利
Yang I. Pachankis

主动，不招人

COVID-19 疫苗接种排毒

COVID-19 呼吸道感染 | COVID-19 压力综合症 | COVID-19 疫苗不良反应 | COVID-19 相关血栓栓塞 | COVID-19 重症监护后综合症 | COVID-19 相关中风

中国
Erasmus Medical Center
Da Vinci Clinic; HGC Rijswijk

尚未招聘

用高压氧疗法治疗新冠肺炎后：一项随机对照试验

COVID-19 后综合症 | 长COVID | 长Covid19 | COVID-19 后状况 | 后 COVID 综合症 | COVID-19 后状况，未指定 | 新冠疫情后的状况

荷兰
Endourage, LLC

招聘中

使用 Formula C™ 舌下滴剂跟踪长期新冠肺炎患者的症状

长COVID | 长Covid19 | 后急性 COVID-19 | 长途 COVID | 长途 COVID-19 | 急性 COVID-19 后综合症

美国
National Institutes of Health Clinical Center (CC)

完全的

无症状和有症状人群 COVID-19 感染临床过程中的心肺炎症和多系统成像

COVID-19 对全身炎症的急性和长期影响 | COVID-19 对肺功能的急性和长期影响 | COVID-19 对心脏功能的急性和长期影响 | COVID-19 对肾功能的急性和长期影响 | COVID-19 对脑功能的急性和长期影响

美国
Jonathann Kuo, MD

主动，不招人

长期 COVID 交感神经介导症状患者的双重交感神经阻滞 (DSBLongCOVID)

SARS-CoV2 感染 | COVID-19 后综合症 | 自主神经障碍 | 急性 COVID-19 后综合症 | 长COVID | 长Covid19 | COVID-19 复发 | 后急性 COVID-19 | 急性 COVID-19 后感染 | COVID-19 的急性后遗症 | 自主神经样障碍 | 自主神经功能障碍直立性低血压综合征 | COVID-19 后状况 | 后 COVID 综合症 | COVID-19 后状况，未指定

美国
Indonesia University

招聘中

远程康复实践对长期 COVID-19 患者的影响

COVID-19 后综合症 | 长COVID | COVID-19 后状况 | 后 COVID 综合症 | 长 COVID-19

印度尼西亚
University of Witten/Herdecke
Institut für Rehabilitationsforschung Norderney

完全的

用于 Covid-19 后综合症患者康复的有氧训练

COVID-19 后综合症 | 长-COVID-19综合症

德国
First Affiliated Hospital Xi'an Jiaotong University
Shangluo Central Hospital; Ankang Central Hospital; Hanzhong Central Hospital; Yulin No.2 Hospital; Nuclear 215 Hospital of Shaanxi Province 和其他合作者

招聘中

中国第一波 COVID-19 期间患者的流行病学和神经影像学队列随访

新冠肺炎 | COVID-19 后综合症 | 后急性 COVID-19 | 急性 COVID-19

中国
Medisch Spectrum Twente
Ziekenhuisgroep Twente; University of Twente

主动，不招人

COVID-19 的长期影响

新冠肺炎 | COVID-19 后综合症 | 长 COVID-19

荷兰

Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation