Today is 2022-08-12

The application of intraoperative Surgical Pleth Index (SPI) monitior in clinical anesthesia
download

注册号:

Registration number:

ChiCTR-OOC-16009450 

最近更新日期:

Date of Last Refreshed on:

2017-12-01 

注册时间:

Date of Registration:

2016-10-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

手术期间SPI监测在临床麻醉中的应用 

Public title:

The application of intraoperative Surgical Pleth Index (SPI) monitior in clinical anesthesia 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

手术期间SPI监测在临床麻醉中的应用 

Scientific title:

The application of intraoperative Surgical Pleth Index (SPI) monitior in clinical anesthesia 

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:

王玉兰 

研究负责人:

嵇富海 

Applicant:

Wang Yulan 

Study leader:

Ji Fuhai 

申请注册联系人电话:

Applicant telephone:

+86 13862571452 

研究负责人电话:

Study leader's telephone:

+86 13656207331 

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:

wylsdfyy@163.com 

研究负责人电子邮件:

Study leader's E-mail:

jifuhai@hotmail.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:

江苏省苏州市十梓街188号 

研究负责人通讯地址:

江苏省苏州市十梓街188号 

Applicant address:

188 Shizi Street, Suzhou, Jiangsu, China 

Study leader's address:

188 Shizi Street, Suzhou, Jiangsu, 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:

苏州大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Soochow 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:

2016-054 

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:

苏州大学附属第一医院医学伦理委员会 

Name of the ethic committee:

Ethics committee of the First Affiliated Hospital of Soochow University 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-08-01 

伦理委员会联系人:

方琪 

Contact Name of the ethic committee:

Fang Qi 

伦理委员会联系地址:

江苏省苏州市十梓街188号 

Contact Address of the ethic committee:

188 Shizi Street, Suzhou, Jiangsu, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0512 67780081 

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:

苏州大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Soochow University 

研究实施负责(组长)单位地址:

江苏省苏州市十梓街188号 

Primary sponsor's address:

188 Shizi Street, Suzhou, Jiangsu, 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):

江苏

市(区县):

苏州

Country:

China

Province:

Jiangsu

City:

Suzhou

单位(医院):

苏州大学附属第一医院

具体地址:

江苏省苏州市十梓街188号

Institution
hospital:

The First Affiliated Hospital of Soochow University

Address:

188 Shizi Street, Suzhou, Jiangsu

经费或物资来源:

自筹 

Source(s) of funding:

raise independently 

研究疾病:

胸腔镜下肺癌根治术、肩袖修补术、输尿管镜下结石手术 

Target disease:

radical resection of lung cancer under thoracoscope, aotator cuff repair and calculi surgery under ureteroscope 

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:

其它 

Study phase:

N/A 

研究目的:

比较不同手术及不同年龄阶段患者手术期间SPI值的变化。 

Objectives of Study:

Compare the changes of the value of SPI during intraoperative period in different surgeries and patients with different ages. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1、择期行胸腔镜下肺癌根治术、肩袖修补术、输尿管镜下结石手术;2、ASAⅠ-Ⅱ级;3、BMI 20-25 kg/m2。 

Inclusion criteria

1. Elective operations including radical resection of lung cancer under thoracoscope, aotator cuff repair and calculi surgery under ureteroscope; 2. American Society of Anesthesiologists (ASA) physical status I–II; 3. Body mass index (BMI)20-25 kg/m2. 

排除标准:

1、年龄﹤18岁;2、既往有心血管系统疾病、肺疾病、肝肾疾病、内分泌系统疾病;3、接受镇痛药物治疗;4、酗酒及接受精神科药物治疗。 

Exclusion criteria:

1. Aged 18 years old or less; 2. A history of cardiovascular, pulmonary, hepatic, renal and endocrine disease; 3. Analgesic drug therapy; 4. A history of alcohol or drug abuse. 

研究实施时间:

Study execute time:

From2016-11-01To 2017-04-28 

征募观察对象时间:

Recruiting time:

From2016-11-01To 2017-04-28 

干预措施:

Interventions:

组别:

1组

样本量:

100

Group:

Group 1

Sample size:

干预措施:

胸腔镜下肺癌根治术

干预措施代码:

Intervention:

Radical resection of lung cancer under thoracoscope

Intervention code:

组别:

2组

样本量:

100

Group:

Group 2

Sample size:

干预措施:

肩袖修补术

干预措施代码:

Intervention:

Aotator cuff repair surgical

Intervention code:

组别:

3组

样本量:

100

Group:

Group 3

Sample size:

干预措施:

输尿管镜下结石手术

干预措施代码:

Intervention:

calculi surgery under ureteroscope surgical

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

苏州 

Country:

China 

Province:

Jiangsu 

City:

Suzhou 

单位(医院):

苏州大学附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of Soochow University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

手术体积描记指数

指标类型:

主要指标 

Outcome:

Surgical Pleth Index

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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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:

Blinding:

是否共享原始数据:

IPD sharing

Yes

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):

试验完成后6个月内上传中国临床试验注册中心(http://www.chictr.org.cn)

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

upload to http://www.chictr.org.cn within six months after the trial complete

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:

采用SPSS软件进行统计学分析,使用Excel表格进行试验记录

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

Excel and SPSS Statistics software

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:

 2016-10-16
return list