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Functional Recovery Over the First Year After ICU Discharge

2021年7月11日更新者：National Taiwan University Hospital

Functional Recovery Over the First Year After ICU Discharge：How ICU-delirium and ICU-acquired Weakness Interact

Intensive Care Unit Acquired Delirium (ICU-AD) and Intensive Care Unit Acquired Weakness (ICU-AW) are common in critically ill, mechanically ventilated adult patients. As more patients survive ICU stays but suffer from long-term functional declines leading to unemployment and disability, research is urgently needed. The aims of this study are to: 1) describe the trajectory of physical functions one year after ICU discharge, including distance walked in 6 minutes (6MWD), hand grip (HGS), maximum inspiratory pressure (MIP), cognitive function (mini mental state examination,MMSE), physical function ICU test score (PFITs) , medical reserach council scale (MRC), medical research council questionnaire (MRC-Q)and basic and instrumental activities of daily living (ADL/IADL); 2) examine the incidences of ICU-AD and ICU-AW; and 3) test the interaction between ICU-AD and ICU-AW on one-year functional trajectories in the ICU survivors.4) compare two tools, the intensive care delirium screening checklist (ICDSC) and confusion assessment method for the ICU (CAM-ICU), for their predictive validity for outcomes related to delirium, hospital mortality and length of stay (LOS), and examined whether the tools' predictive validity was affected by patients' arousal status (RASS≥0, RASS<0).

研究概览

地位

完全的

条件

详细说明

For this 3-year cohort study, consecutive ICU stay over 24 hours and adult patients (≧20 years) will be screened for enrollment at 6 medical ICUs in the National Taiwan University Hospital. Participants will be assessed daily for delirium occurrence for up to 14 days of ICU stay, and again upon ICU discharge. The instrument used for delirium are the confusion assessment method for ICU (CAM-ICU) and the intensive care delirium screening checklist (ICDSC). The 7 point rating scale of CAM-ICU-7 will also be used to rate the severity of delirium. Delirium assessment is possible,if the the patient's Richmond Agitation and Sedation Scale (RASS, -5~+4) is ≧ -3, -4~-5 are deeper levels of sedation (unarousable or responsive to painful stimulation only) cannot be assessed accurately. The CAM-ICU comprises four features which assess the following: acute change or fluctuation in mental status (Feature 1), inattention (Feature 2), disorganized thinking (Feature 3) or an altered level of consciousness (Feature 4). Patients are considered to have delirium if they present with both the first (acute onset and fluctuating course) and second (inattention) core symptoms and either the third (altered consciousness) or fourth (disorganized thinking) symptom. The ICDSC comprises eight items (score 0-8), ICDSC score of 4 or higher are considered delirium.

At ICU discharge,assess ICU-AW using a standardized protocol. Participants will be followed for one year after ICU discharge at 1, 3, 6, 12 months. A comprehensive functional evaluation (6-minute walking test, grip strength test, maximum inspiratory pressure test, mini-mental state exam, physical function ICU test score and basic and instrument activities of daily living questionnaires, medical research council scale and medical research council questionnaire) will be completed. Estimated 158 participants will be enrolled and followed for one year.

Data will be analyzed using the SPSS package. For example, the Generalized Estimating Equation (GEE) will be performed to delineate the trajectory of physical functions one year after ICU discharge and to test the interaction among ICU-AD, ICU-AW, and one-year functional trajectories. The findings will add to the development of intervention program to reduce ICU-AD and ICU-AW, thus promoting functional recovery for ICU survivors.

研究类型

观察性的

注册 (实际的)

407

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

台湾
- - Taipei City、台湾、10055
    - National Taiwan University Hospital

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

20年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Consecutive about patients (≧20 years) admitted to the six medical intensive care units at the National Taiwan University Hospital (NTUH).

描述

Inclusion Criteria:

Patient who is 20 years or older.

Exclusion Criteria:

patients who presented with preexisting delirium at ICU admission
patients who were placed on contact and droplet precaution
patient who is long-term bedridden, moderate to severe dementia
expected ICU length of stay less than 24 hours
unable to communicate in Mandarin or Taiwanese
unable to follow command completely

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

观测模型：队列
时间观点：预期

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
Change from baseline 6-min walking distance to one year after ICU discharge 大体时间：Baseline at ICU discharge one month. One,two, three,six month and one year after ICU discharge	Measured by distance walked in 6 minutes(6MWT) in meter, range from 400 to 700 meters, higher value indicated better global health condition	Baseline at ICU discharge one month. One,two, three,six month and one year after ICU discharge
Change from baseline hand grip strength to one year after ICU discharge 大体时间：Baseline at ICU discharge. One, two, three,six month and one year after ICU discharge	Measured by hand grip strength (HGS) in kg, range from 20 to 65 kg, higher value indicated better musculoskeletal function	Baseline at ICU discharge. One, two, three,six month and one year after ICU discharge
Maximum inspiratory pressure, from baseline to one year after ICU discharge 大体时间：Baseline at ICU discharge one month. Two, three, six month and one year after ICU discharge	Measured by maximum inspiratory pressure (MIP test ) in cmH2O, normal range < -20 cmH2O, lower value indicated better respiratory muscle condition	Baseline at ICU discharge one month. Two, three, six month and one year after ICU discharge
Change from baseline Mini-Mental State Examination to one year after ICU discharge 大体时间：Baseline at ICU discharge. One, two, three, six month and one year after ICU discharge	Measured by Mini-Mental State Examination (MMSE) in score, range from 0 to 30 score, higher score indicated better cognitive function	Baseline at ICU discharge. One, two, three, six month and one year after ICU discharge
Physical function, from baseline to 3 months after ICU discharge 大体时间：Baseline at ICU discharge. One, two and three month after ICU discharge	Measured by Physical function ICU test score (PFITs) in score, range from 0 to 10 score, higher score indicated better health condition.	Baseline at ICU discharge. One, two and three month after ICU discharge
Activities of daily living score, from baseline to one year after ICU discharge 大体时间：Baseline before hospital admission. ICU discharge, one, two, three,six month and one year after ICU discharge	Measured by basic activities of daily living (ADL) in score, range from 0-100 score, higher score indicated health condition	Baseline before hospital admission. ICU discharge, one, two, three,six month and one year after ICU discharge
Instrumental activities of daily living score, from baseline to one year after ICU discharge 大体时间：Baseline at ICU discharge one month. Two, three, six month and one year after ICU discharge	Measured by instrumental activities of daily living (IADL) in score, range from 0 to 8 score, higher score indicated better health condition	Baseline at ICU discharge one month. Two, three, six month and one year after ICU discharge
Scores of Medical Research Council (MRC) scale, from baseline to one year after ICU discharge 大体时间：Baseline at ICU discharge. One year after ICU discharge	Measured by medical research council scale (MRC) in score, range from 0 to 60 score, higher score indicated better muscle strength	Baseline at ICU discharge. One year after ICU discharge
Self-report MRC questionnaire score 大体时间：At ICU discharge one month	range from 0 to 60, score greater than or equal to 48, classified as no muscle weakness	At ICU discharge one month

次要结果测量

结果测量	措施说明	大体时间
ICU, hospital and one-year mortality 大体时间：death (yes/no) at ICU, at hospital, and one year after ICU discharge obtained by family interview and medical record	death (yes/no) at ICU, at hospital, and one year after ICU discharge obtained by family interview and medical record	death (yes/no) at ICU, at hospital, and one year after ICU discharge obtained by family interview and medical record
Length of ICU and hospital stay (day) 大体时间：calculated a duration of ICU and hospitalization, obtained by medical record	calculated a duration of ICU and hospitalization, obtained by medical record	calculated a duration of ICU and hospitalization, obtained by medical record

其他结果措施

结果测量	措施说明	大体时间
Time spent administering delirium tools 大体时间：time spent (minutes) administering ICDSC vs CAM-ICU was automatically recorded by the REDCap data collection system	time spent (minutes) administering ICDSC vs CAM-ICU was automatically recorded by the REDCap data collection system	time spent (minutes) administering ICDSC vs CAM-ICU was automatically recorded by the REDCap data collection system

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

National Taiwan University Hospital

调查人员

首席研究员：Cheryl Chia-Hui Chen Chen, PhD、School of Nursing, College of Medicine, National Taiwan University

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)

2018年8月14日

初级完成 (实际的)

2020年11月26日

研究完成 (实际的)

2021年7月12日

研究注册日期

首次提交

2018年8月8日

首先提交符合 QC 标准的

2019年12月18日

首次发布 (实际的)

2019年12月20日

研究记录更新

最后更新发布 (实际的)

2021年7月15日

上次提交的符合 QC 标准的更新

2021年7月11日

最后验证

2021年7月1日

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Functional Recovery Over the First Year After ICU Discharge