今天是:2022-08-12 星期五

系统性使用FOIS量表对脑卒中患者的影响
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注册号:

Registration number:

ChiCTR2200061887 

最近更新日期:

Date of Last Refreshed on:

2022-07-22 

注册时间:

Date of Registration:

2022-07-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

系统性使用FOIS量表对脑卒中患者的影响 

Public title:

Impact of the systematic use of the Functional Oral Intake Scale in stroke patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

系统性使用FOIS量表对脑卒中患者的影响 

Scientific title:

Impact of the systematic use of the Functional Oral Intake Scale in stroke patients 

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:

段霞 

研究负责人:

段霞 

Applicant:

Duan Xia 

Study leader:

Duan Xia 

申请注册联系人电话:

Applicant telephone:

18227323182 

研究负责人电话:

Study leader's telephone:

18227323182 

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:

407401735@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

407401735@qq.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:

中国重庆市沙坪坝区高滩岩正街30号 

研究负责人通讯地址:

中国重庆市沙坪坝区高滩岩正街30号 

Applicant address:

30 Gaotanyan Main Street,Shapingba District,Chongqing,China 

Study leader's address:

30 Gaotanyan Main Street,Shapingba District,C 

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:

陆军军医大学第一附属医院 

Applicant's institution:

The First Hospital Affiliated to AMU 

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:

(B)KY2021191 

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:

陆军军医大学第一附属医院伦理委员会 

Name of the ethic committee:

Ethics Commitee of The First Hospital Affiliated to AMU 

伦理委员会批准日期:

Date of approved by ethic committee:

2022-07-13 

伦理委员会联系人:

贺莉 

Contact Name of the ethic committee:

He Li 

伦理委员会联系地址:

中国重庆市沙坪坝区高滩岩正街30号 

Contact Address of the ethic committee:

30 Gaotanyan Main Street,Shapingba District,Chongqing,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:

陆军军医大学第一附属医院 

Primary sponsor:

The First Hospital Affiliated to AMU 

研究实施负责(组长)单位地址:

中国重庆市沙坪坝区高滩岩正街30号 

Primary sponsor's address:

30 Gaotanyan Main Street,Shapingba District,Chongqing,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):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

陆军军医大学第一附属医院

具体地址:

中国重庆市沙坪坝区高滩岩正街30号

Institution
hospital:

The First Hospital Affiliated to AMU

Address:

30 Gaotanyan Main Street,Shapingba District,Chongqing,China

经费或物资来源:

无 

Source(s) of funding:

None 

研究疾病:

脑卒中 

Target disease:

stroke 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

本研究通过回顾性分析近三年收治的脑卒中患者的临床资料,探究系统性应用FOIS量表对脑卒中患者的影响。 

Objectives of Study:

This study retrospectively analyzed the clinical data of stroke patients admitted in recent three years to explore the influence of systematic application of FOIS scale on stroke patients. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

经头颅CT或MRI证实首次脑卒中患者;年龄大于18岁;病程小于1年。 

Inclusion criteria

Patients with first stroke confirmed by head CT or MRI; Older than 18 years of age; The course of disease is less than 1 year. 

排除标准:

气管插管患者昏迷患者既往有其他影响吞咽的病史;入院前存在肺炎。 

Exclusion criteria:

The coma patient with endotracheal intubation had a history of other swallowing problems; Pneumonia was present before admission. 

研究实施时间:

Study execute time:

From2022-07-05To 2022-09-30 

征募观察对象时间:

Recruiting time:

From2022-07-05To 2022-09-30 

干预措施:

Interventions:

组别:

Case series

样本量:

450

Group:

Case series

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

陆军军医大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Hospital Affiliated to AMU  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

成都三六三医院 

单位级别:

三级甲等 

Institution
hospital:

Chengdu 363 Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

洼田饮水试验

指标类型:

主要指标 

Outcome:

water swallowing test

Type:

Primary indicator 

测量时间点:

入院3天内

测量方法:

Measure time point of outcome:

Within 3 days of admission

Measure method:

指标中文名:

功能性经口摄食量表

指标类型:

主要指标 

Outcome:

Functional Oral Intake Scale

Type:

Primary indicator 

测量时间点:

入院3天内

测量方法:

Measure time point of outcome:

Within 3 days of admission

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

胸部X线/CT

组织:

Sample Name:

Chest X ray /CT

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

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 85 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):

回顾性研究,无随机分组。根据既往在不同时间段内,采用了不同筛查吞咽障碍的方法,将受试者分为WST组或FOIS组。

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

Retrospective study, no randomization. Subjects were assigned to either the WST or FOIS groups based on previous screening for swallowing disorders at different time periods.

盲法:

Blinding:

None.

是否共享原始数据:

IPD sharing

否No

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):

http://www.xnyy.cn

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

http://www.xnyy.cn

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:

病例记录表与电子采集和管理系统

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

Case Record Form,CRF and Electronic Data Capture, EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2022-07-06
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