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应用微创性血流动力学监测指导脑外科危重患者术中液体管理及改善预后的临床研究
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注册号:

Registration number:

ChiCTR-TRC-13003583 

最近更新日期:

Date of Last Refreshed on:

2016-03-08 

注册时间:

Date of Registration:

2013-08-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

应用微创性血流动力学监测指导脑外科危重患者术中液体管理及改善预后的临床研究 

Public title:

Hemodynamic monitoring and postoperative management using Vigileo (SVV) for high risk patient during neurosurgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

应用微创性血流动力学监测指导脑外科危重患者术中液体管理及改善预后的临床研究 

Scientific title:

Hemodynamic monitoring and postoperative management using Vigileo (SVV) for high risk patient during neurosurgery 

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:

薛静 

研究负责人:

陈果 

Applicant:

Jing Xue 

Study leader:

Guo Chen 

申请注册联系人电话:

Applicant telephone:

+86 13540174489 

研究负责人电话:

Study leader's telephone:

+86 18980601577 

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:

314255746@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

grace_chenguo@hotmail.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

www.westicu.cn 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

www.westicu.cn 

申请注册联系人通讯地址:

四川省成都市外南国学巷37号四川大学华西医院麻醉科 

研究负责人通讯地址:

四川省成都市外南国学巷37号四川大学华西医院麻醉科 

Applicant address:

37 Guoxuexiang, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxuexiang, Chengdu, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

610041 

研究负责人邮政编码:

Study leader's postcode:

610041 

申请人所在单位:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan 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:

2012-104 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

四川大学华西医院临床试验与生物医学伦理专委会 

Name of the ethic committee:

Ethics Committee of West China Hospital, Sichuan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-05-02 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

成都市外南国学巷37号 

Primary sponsor's address:

37 Guoxuexiang, Chengdu, Sichuan, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

四川大学教育基金会及四川省科技厅 

Source(s) of funding:

Sichuan university education foundation and the Science and technology department of Sichuan Province 

研究疾病:

脑部疾病需要外科治疗 

Target disease:

Patient of neurosurgery 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

1) 通过调节监测的心脏每博量变异系数(SVV)及心脏指数(CI),研究如何通过微创性血液动力学监测仪vigileo维持围术期机体循环的稳定。同时与食道超声的比较研究,评价微创性血液动力学监测仪vigileo对脑外科危重手术患者液体输注量监测的准确性。 2) 通过对SVV的研究减少术中及术后循环容量不足或过多的情况,促进术后脏器功能恢复,降低术后相关并发症及术后死亡率,减少临床住院日及ICU住院日,最终达到改善患者预后,降低医疗成本的目的。 

Objectives of Study:

1). The study intends to maintain the hemodynamic stability through Vigileo for the high risk patients during neurosurgery. All the hemodynamic parameters, such as SVV and CI come from Vigileo will be compared with those caught from transesophageal echocardiography at the same time. 2). We want to see if the goal direct treatment through SVV and CI for the high risk patients could improve the outcome of the patients after the neurosurgery, it may decreased the ratio of complication morbility and mortality, shorten the length of hospital stay and ICU stay and decreased the cost of inpatient. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1)在我院医学中心行脑外手术患者。 2)手术具有以下特点(至少具备一项):A,手术时间长于120分钟。B,术中失血量大于800ml。C,患者具有以下并发症(至少具备一项):I.缺血性心脏疾病或心功能在3 级以上。II.中等或严重的慢性阻塞性肺部疾病。III.年龄>70岁。IV.ASA3级以上或有慢性肾功能不全、糖尿病等。 

Inclusion criteria

1. all the neurosurgery patients in West China Hospital will be involved in our study; 2. At least one of below characteristics: (1) The length of operation is more than 120 mins; (2) Blood loss more than 800 ml during the surgery; (3) Have at least one of below complications: 1) Ischemic heart disease or Heart function classification (NYHA) more than III; 2) Moderate or severe chronic obstructive pulmonary disease (COPD); 3) aged more than 70 yrs; 4) American Standards Association classification (ASA) more than 3 degree, or chronic renal insufficiency and diabetes mellitus. 

排除标准:

1)心律不齐。2)体重低于55kg或高于140kg。3)年龄低于18岁。 

Exclusion criteria:

1. arrhythmia; 2. weight less than 55 kg or above 140 kg; 3. the age under 18 years of age. 

研究实施时间:

Study execute time:

From2013-08-20To 2015-12-31 

征募观察对象时间:

Recruiting time:

From2013-08-20To 2014-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

75

Group:

the trial group

Sample size:

干预措施:

通过微创血流动力学监测每搏量变异度和心指数知道容量治疗

干预措施代码:

Intervention:

goal direct treatment through SVV and CI come from Vigileo

Intervention code:

组别:

对照组

样本量:

75

Group:

control group

Sample size:

干预措施:

根据经验进行容量治疗

干预措施代码:

Intervention:

According to the experience of treatment capacity

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川大学华西医院 

单位级别:

三级甲等 

Institution
hospital:

West China Hospital, Sichuan University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

1) 术后8和24小时评价患者POSSUM得分。

指标类型:

主要指标 

Outcome:

P-POSSUM scoring at the postoperative 8 hrs and 24 hrs for mortality prediction in general neurosurgery

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

2) 根据上述评分标准计算患者的并发症发生率和死亡率。

指标类型:

主要指标 

Outcome:

Calculate the ratio of complication morbility and mortality based on the formula.

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

3) 观察患者术后到出院期间有无感染及相关并发症(包括心、肺、胃肠道、肾、血栓形成)

指标类型:

主要指标 

Outcome:

All the complications, including cardiac, pulmonary, renal, gastrointestinal complications and thrombosis.

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

4) 记录患者在ICU的时间及术后总的住院时间。

指标类型:

主要指标 

Outcome:

Length of hospital stay and ICU stay;Mortality of the patients

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

5) 统计患者术后的死亡率。

指标类型:

主要指标 

Outcome:

Mortality of the patients

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中每小时及术后4小时、8小时和24小时动脉及静脉血气

指标类型:

次要指标 

Outcome:

Arterial and venous blood gas analysis every one hour during the surgery and at 4 hrs, 8 hrs and 24 hrs after surgery

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中及术后8小时输液量,种类,使用血管活性药物的量。

指标类型:

次要指标 

Outcome:

The type and the volume of fluid, including RBC, plasma, platelet, crystoloid solution and colloid fluid during the surgery and at 8 hrs after surgery.

Type:

Secondary 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:

血液

组织:

动脉、静脉

Sample Name:

Blood

Tissue:

artery and vein

人体标本去向

使用后销毁 

说明

使用后立即销毁

Fate of sample:

Destruction after use 

Note:

Destruction immediately after use

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 100 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):

计算机软件

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

Computer Software

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

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

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:

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

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:

 2013-08-20
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