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体外循环心脏术后谵妄患者生理指标昼夜节律特征的研究
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注册号:

Registration number:

ChiCTR1900022408 

最近更新日期:

Date of Last Refreshed on:

2019-04-10 

注册时间:

Date of Registration:

2019-04-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

体外循环心脏术后谵妄患者生理指标昼夜节律特征的研究 

Public title:

Circadian rhythm of physiological parameters in patients with delirium after cardiopulmonary bypass 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

心外循环心脏术后谵妄患者生理指标昼夜节律特征的研究 

Scientific title:

Circadian rhythm of physiological parameters in patients with delirium cardiopulmonary bypass 

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:

林雁娟 

研究负责人:

林雁娟 

Applicant:

Yanjuan Lin 

Study leader:

Yanjuan Lin 

申请注册联系人电话:

Applicant telephone:

+86 0591 86218336 

研究负责人电话:

Study leader's telephone:

+86 0591 86218336 

申请注册联系人传真 :

Applicant Fax:

+86 0591 83344034 

研究负责人传真:

Study leader's fax:

+86 0591 83344034 

申请注册联系人电子邮件:

Applicant E-mail:

fjxhyjl@163.com 

研究负责人电子邮件:

Study leader's E-mail:

fjxhyjl@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:

福建省福州鼓楼区新权路29号福建医科大学附属协和医院 

研究负责人通讯地址:

福建省福州鼓楼区新权路29号福建医科大学附属协和医院 

Applicant address:

29 Xinquan Road, Gulou District, Fuzhou, Fujian, China  

Study leader's address:

29 Xinquan Road, Gulou District, Fuzhou, Fujian, 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:

福建医科大学附属协和医院 

Applicant's institution:

Fujian Medical University Unoin Hospital 

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:

2019KY019 

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:

福建医科大学附属协和医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Fujian Medical University Union Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-31 

伦理委员会联系人:

赖晓钰 

Contact Name of the ethic committee:

Xiaoyu Lai 

伦理委员会联系地址:

福建省福州鼓楼区新权路29号福建医科大学附属协和医院行政楼5楼 

Contact Address of the ethic committee:

5th Floor, Administration Building, Fujian Medical University Union Hospital, 29 Xinquan Road, Gulou District, Fuzhou, Fujian, 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:

福建医科大学附属协和医院 

Primary sponsor:

Fujian Medical University Unoin Hospital 

研究实施负责(组长)单位地址:

福建省福州鼓楼区新权路29号福建医科大学附属协和医院 

Primary sponsor's address:

29 Xinquan Road, Gulou District, Fuzhou, Fujian, 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):

福建省

市(区县):

福州市

Country:

China

Province:

Fujian

City:

Fuzhou

单位(医院):

福建医科大学附属协和医院

具体地址:

鼓楼区新权路29号

Institution
hospital:

Fujian Medical University Unoin Hospital

Address:

29 Xinquan Road, Gulou District

经费或物资来源:

福建省科技创新联合资金项目资助 

Source(s) of funding:

Joint Finders for the innovation of science and Technology, Fujian Province 

研究疾病:

谵妄 

Target disease:

delirium 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

本研究采用前瞻性病例对照研究方法,分析体外循环心脏术后患者发生谵妄之前的体温、呼吸、心率、血压、血氧饱和度(Oxygen saturation, SpO2)及动脉血氧分压(arterial partial pressure of oxygen, PaO2)生理指标的昼夜节律特征,为护理人员对谵妄的预测提供简单、便利的生理指标;分析体外循环心脏术后患者谵妄相关生理数的昼夜节律性为临床治疗、病情监测、判断预后以及时间护理学提供科学依据。 

Objectives of Study:

This study used a prospective case-control study to analyze body temperature, respiration, heart rate, blood pressure, oxygen saturation (S02), and arterial partial pressure of arterial oxygen pressure before cardiopulmonary bypass. Oxygen, PaO2) circadian rhythm of physiological indicators, providing simple and convenient physiological indicators for the nurses to predict sputum; analyzing the circadian rhythm of the physiological numbers of POD in thecardiopulmonary bypass for clinical treatment, disease monitoring, prognosis and time Nursing provides a scientific basis. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

病例组纳入标准:①年龄18~85岁;②肝、肾、肺功能正常;③ICU意识模糊评分法(CAM-ICU)评分阳性患者;④患者知情同意。 对照组纳入标准:①年龄18~85岁;②肝、肾、肺功能正常;③患者知情同意。 

Inclusion criteria

The case group: 1 aged 18 to 85 years; 2 liver, kidney, lung function was normal; 3 ICU consciousness fuzzy score (CAM-ICU) score positive patients; 4 patients informed consent. The control group: 1 aged 18 to 85 years; 2 liver, kidney, lung function normal; 3 patients informed consent. 

排除标准:

病例组排除标准: ①术后入住ICU时间小于24小时者;②有颅脑外伤既往史或现病史;③术前患有精神分裂症、癫痫。 对照组排除标准:①术后入住ICU时间小于24小时者;②CAM-ICU评分阳性患者;③有颅脑外伤既往史或现病史;④术前患有精神分裂症、癫痫。 

Exclusion criteria:

Case group exclusion criteria: 1 postoperative ICU time less than 24 hours; 2 history of traumatic brain injury or current history; 3 preoperative schizophrenia, epilepsy. Exclusion criteria in the control group: 1 those who stayed in the ICU for less than 24 hours after surgery; 2 patients with positive CAM-ICU scores; 3 had a history of current traumatic brain injury or current medical history; 4 had schizophrenia and epilepsy before surgery. 

研究实施时间:

Study execute time:

From2019-04-10To 2023-12-31 

征募观察对象时间:

Recruiting time:

From2019-04-10To 2023-12-31 

干预措施:

Interventions:

组别:

发生谵妄组

样本量:

400

Group:

Delirium group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

未发生谵妄组

样本量:

600

Group:

Non-Delirium group

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):

福建 

市(区县):

 

Country:

China 

Province:

Fujian 

City:

 

单位(医院):

福建医科大学附属协和医院 

单位级别:

三级甲等 

Institution
hospital:

Fujian Medical University Unoin Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

生命体征

指标类型:

主要指标 

Outcome:

vital signs

Type:

Primary indicator 

测量时间点:

入住ICU每小时监测一次

测量方法:

心电监护仪

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

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):

N/A

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:

即时公开/Real time access

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):

临床试验公共管理平台, http://www.medresman.org

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

Clinical Trial Management Public Platform, http://www.medresman.org

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:

福建医科大学附属协和医院心脏外科病历系统

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

Department of Cardiac Surgery Medical Records, Union Hospital, Fujian Medical University

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-04-10
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