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下腔静脉超声指导输液对预防腰麻后低血压的应用探讨
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注册号:

Registration number:

ChiCTR1900027848 

最近更新日期:

Date of Last Refreshed on:

2019-11-30 

注册时间:

Date of Registration:

2019-11-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

下腔静脉超声指导输液对预防腰麻后低血压的应用探讨 

Public title:

The Utility of Vena Cava Ultrasound for the Prediction of Hypotension during Spinal Anesthesia in Spontaneously Breathing Patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

下腔静脉超声指导输液对预防腰麻后低血压的应用探讨 

Scientific title:

The Utility of Vena Cava Ultrasound for the Prediction of Hypotension during Spinal Anesthesia in Spontaneously Breathing 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:

倪婷婷 

研究负责人:

倪婷婷 

Applicant:

Ni Tingting 

Study leader:

Ni Tngting 

申请注册联系人电话:

Applicant telephone:

+86 13732130748 

研究负责人电话:

Study leader's telephone:

+86 13732130748 

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:

342163420@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

342163420@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:

浙江省宁波市镇海区骆驼街道海悦花苑12幢703室 

研究负责人通讯地址:

浙江省宁波市镇海区骆驼街道海悦花苑12幢703室 

Applicant address:

Room 703, Building 12th, Haiyue Garden, Zhenhai District, Ningbo, Zhejiang, China 

Study leader's address:

Room 703, Building 12th, Haiyue Garden, Zhenhai District, Ningbo, Zhejiang, 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:

宁波市第七医院 

Applicant's institution:

Ningbo 7th 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:

2019014 

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:

宁波市第七医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Ningbo 7th Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

王镇 

Contact Name of the ethic committee:

Wang Zheng 

伦理委员会联系地址:

宁波市第七医院 

Contact Address of the ethic committee:

Ningbo 7th Hospital 

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:

宁波市第七医院 

Primary sponsor:

Ningbo 7th Hospital 

研究实施负责(组长)单位地址:

宁波市镇海区骆驼街道南二西路718号 

Primary sponsor's address:

718 West Nan'er Road, Luotuo Street, Zhenhai District, Ningbo, Zhejiang, 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):

浙江省

市(区县):

宁波市

Country:

China

Province:

Zhejiang

City:

Ningbo

单位(医院):

宁波市第七医院

具体地址:

宁波市镇海区骆驼街道南二西路718号

Institution
hospital:

Ningbo 7th Hospital

Address:

718 West Nan'er Road, Luotuo Street, Zhenhai District

经费或物资来源:

宁波市第七医院 

Source(s) of funding:

Ningbo 7th Hospital 

研究疾病:

腰麻病人的麻醉 

Target disease:

spinal anesthesia 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

初步探讨运用超声测量下腔静脉呼气末最大直径(dIVCmax)、吸气末最小直径(dIVCmin)和下腔静脉塌陷指数(IVC-CI)的变化在预测腰麻后低血压发生的价值,探寻最佳预测指标。 

Objectives of Study:

Therefore, this study aims to assess the predictive power of the IVCmax, IVCmin, and IVCCI, before spinal anesthesia in spontaneously breathing patients who fulfilled predetermined inclusion criteria 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

⑴在腰麻下行择期手术(非产科、心脏、血管手术)的患者 ⑵ASA I~III,年龄18-65岁。 ⑶签署知情同意书,能接受实验方法,自愿作为受试对象。 

Inclusion criteria

Consecutive ASA 1-2 patients aged 18-65 year scheduled for non-cardiovascular, non-obstetric surgery under spinal anaesthesia. 

排除标准:

1)麻醉前低血压(收缩压<90mmHg或脉压<60mmHg)。 2)腰麻禁忌症。 3)腰麻失败。 

Exclusion criteria:

A prexisting arterial hypotension, absolute contraindications or failure to perform spinal anaesthesia and patients scheduled for unilateral spinal anaesthesia 

研究实施时间:

Study execute time:

From2020-01-01To 2020-06-30 

诊断试验:

Diagnostic Tests:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

临床结局

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Clinical outcome

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

超声测量下腔静脉呼气末最大直径(dIVCmax)、吸气末最小直径(dIVCmin)和下腔静脉塌陷指数(IVC-CI)

Index test:

the IVCmax, IVCmin, and IVCCI

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

腰麻下行择期手术(非产科、心脏、血管手术)的患者

例数:

Sample size:

90

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Patients aged 18-65 year scheduled for non-cardiovascular, non-obstetric surgery under spinal anaesthesia

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

宁波 

Country:

China 

Province:

Zhejiang 

City:

Ningbo 

单位(医院):

宁波市第七医院 

单位级别:

二甲 

Institution
hospital:

Ningbo 7th Hospital  

Level of the institution:

Second A Hospital 

测量指标:

Outcomes:

指标中文名:

下腔静脉塌陷指数

指标类型:

主要指标 

Outcome:

IVC-CI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

下腔静脉呼气末最大直径

指标类型:

主要指标 

Outcome:

dIVCmax

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

下腔静脉吸气末最小直径

指标类型:

主要指标 

Outcome:

dIVCmin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SPE, SEN, ACC, AUC of ROC

指标类型:

主要指标 

Outcome:

SPE, SEN, ACC, AUC of ROC

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 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):

none

盲法:

No

Blinding:

No

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

中国临床试验注册中心

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

chinese clinical trial registry

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:

中国临床试验注册中心

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

chinese clinical trial registry

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-11-30
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