今天是:2019-07-21 星期日

重症患者转出ICU后认知损害发生现状及影响因素研究
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注册号:

Registration number:

ChiCTR1900021022 

最近更新日期:

Date of Last Refreshed on:

2019-02-28 

注册时间:

Date of Registration:

2019-01-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

重症患者转出ICU后认知损害发生现状及影响因素研究  

Public title:

A study for the status quo and influencing factors of cognitive impairment in critically ill patients after ICU discharge 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

重症患者转出ICU后认知损害发生现状及影响因素研究  

Scientific title:

A study for the status quo and influencing factors of cognitive impairment in critically ill patients after ICU discharge 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

姚丽 

研究负责人:

张志刚 

Applicant:

Yao Li 

Study leader:

Zhang Zhigang 

申请注册联系人电话:

Applicant telephone:

+86 18394815452 

研究负责人电话:

Study leader's telephone:

+86 13919093444 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

liyao5452@126.com 

研究负责人电子邮件:

Study leader's E-mail:

zzg3444@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

甘肃省兰州市城关区雁西路28号 

研究负责人通讯地址:

甘肃省兰州市城关区东岗西路1号 

Applicant address:

28 Yanxi Road, Chengguan District, Lanzhou, Gansu, China 

Study leader's address:

1 Donggang Road West, Chengguan District, Lanzhou, Gansu, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

兰州大学护理学院 

Applicant's institution:

Nursing School of Lanzhou University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

LDYYLL2018-173 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

兰州大学第一医院伦理委员会 

Name of the ethic committee:

Ethics Committee,the First Hospital of Lanzhou University  

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

郭顺林 

Contact Name of the ethic committee:

Guo Shunlin 

伦理委员会联系地址:

甘肃省兰州市城关区东岗西路1号 

Contact Address of the ethic committee:

1 Donggang Road West, Chengguan District, Lanzhou, Gansu, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

兰州大学第一医院 

Primary sponsor:

The First Hospital Of Lanzhou University  

研究实施负责(组长)单位地址:

甘肃省兰州市城关区东岗西路1号 

Primary sponsor's address:

1 Donggang Road West, Chengguan District, Lanzhou, Gansu, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

甘肃省

市(区县):

Country:

China

Province:

Gansu

City:

单位(医院):

兰州大学第一医院

具体地址:

甘肃省兰州市城关区东岗西路1号

Institution
hospital:

The First Hospital Of Lanzhou University

Address:

Donggang West Road 1,Chengguan District,Lanzhou,Gansu

经费或物资来源:

自筹 

Source(s) of funding:

Self-raising 

研究疾病:

认知损害 

Target disease:

Cognitive impairement 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

1.了解ICU后认知损害的发生现状及变化轨迹; 2.得出ICU后认知损害的影响因素。 

Objectives of Study:

1. Understand the current status and changes of cognitive impairment after ICU; 2. Influencing factors of cognitive impairment after ICU. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1. ICU住院时间≥24h; 2. 年龄≥18岁; 3. 知情同意者。 

Inclusion criteria

1. ICU Hospitalization lasts at least 24 hours; 2. Aged at least 18 years; 3. Get Informed consent. 

排除标准:

1. ICU入院前存在认知损害,Blessed评分>3的患者; 2. 存在重大精神疾病或先天智力障碍的患者; 3. 有严重视力和听力障碍,不能完成量表测试的患者; 4. 以往出现脑梗塞、脑膜炎、颅脑损伤等疾病后遗留智力障碍的患者; 5. 酗酒及药物滥用者。 

Exclusion criteria:

1. Patients with cognitive impairment before admission to the ICU, with a Blessed score >3; 2. patients with major mental illness or congenital mental retardation; 3. patients with severe vision and hearing impairment who are unable to complete the scale test; 4. Patients with mental retardation after cerebral infarction, meningitis, and head injury; 5. Alcohol abuse and drug abusers. 

研究实施时间:

Study execute time:

From2018-06-27To 2021-06-27 

干预措施:

Interventions:

组别:

连续病例

样本量:

406

Group:

Case Series

Sample size:

干预措施:

N/A

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

甘肃省 

市(区县):

兰州 

Country:

China 

Province:

Gansu 

City:

Lanzhou 

单位(医院):

兰州大学第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Hospital Of Lanzhou University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

MoCA评分

指标类型:

主要指标 

Outcome:

MoCA score

Type:

Primary indicator 

测量时间点:

出院当天

测量方法:

当面评价

Measure time point of outcome:

Discharge day

Measure method:

Face to face evaluation

指标中文名:

TICS-m评分

指标类型:

主要指标 

Outcome:

TICS-m评分

Type:

Primary indicator 

测量时间点:

出院当天、出院后1个月、3个月、6个月

测量方法:

出院当天当面评价,1 个月、3个月、6个月时电话评价

Measure time point of outcome:

Discharge day,1,3,6months after hospital discharge

Measure method:

face to face and by telephone

指标中文名:

谵妄

指标类型:

附加指标 

Outcome:

delirium

Type:

Additional indicator 

测量时间点:

ICU 住院期间

测量方法:

面对面

Measure time point of outcome:

during ICU hospitalization

Measure method:

face to face

指标中文名:

社会支持水平现状

指标类型:

附加指标 

Outcome:

Status of social support

Type:

Additional indicator 

测量时间点:

出院当天

测量方法:

询问患者本人或家属

Measure time point of outcome:

Discharge day

Measure method:

Ask the patient or family member

指标中文名:

EQ-5D评分

指标类型:

次要指标 

Outcome:

EQ-5D score

Type:

Secondary indicator 

测量时间点:

出院后1个月、3个月、6个月

测量方法:

询问患者本人或家属

Measure time point of outcome:

1,3,6months after discharge

Measure method:

Ask the patient or family member

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 90 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

2021年12月

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

December 2021

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

① 患者入ICU时采用Blessed评定量表询问知情者,排除先前认知损害的患者,入ICU 24h内收集患者最差APACHE II评分和Charlson共病指数,患者住ICU期间收集患者一般信息和疾病治疗资料; ② 采用RASS、CAM-ICU、ICDSC量表每天早上8:00评价患者是否存在谵妄及严重程度; ③ 在患者出院当天、出院后1个月、3个月和6个月评价ICU幸存者认知水平。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

① When the patient entered the ICU, the Blessed rating scale was used to query the informed patients. Patients with previous cognitive impairment were excluded. The worst APACHE II score and Charlson comorbidity index were collected within 24 hours of ICU. Patients were collected during the ICU and general information and disease treatment were collected. data; ② Use the RASS, CAM-ICU, ICDSC scale to evaluate the presence and severity of the patient at 8:00 am every day; ③ ICU survivors' cognitive levels were evaluated on the day of discharge from the patient, 1 month, 3 months, and 6 months after discharge.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-01-25
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