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Establishment and clinical application study of individualized protective ventilation strategy in patients with robot-assisted radical prostatectomy.
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注册号:

Registration number:

ChiCTR1800015626 

最近更新日期:

Date of Last Refreshed on:

2018-04-12 

注册时间:

Date of Registration:

2018-04-12 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

机器人辅助前列腺癌根治患者个体化保护性通气策略的制定及其临床应用研究  

Public title:

Establishment and clinical application study of individualized protective ventilation strategy in patients with robot-assisted radical prostatectomy. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

机器人辅助前列腺癌根治患者个体化保护性通气策略的制定及其临床应用研究 

Scientific title:

Establishment and clinical application study of individualized protective ventilation strategy in patients with robot-assisted radical prostatectomy. 

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:

谢俊然 

研究负责人:

谢俊然 

Applicant:

Junran Xie 

Study leader:

Junran Xie 

申请注册联系人电话:

Applicant telephone:

+86 13858126216 

研究负责人电话:

Study leader's telephone:

+86 13858126216 

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:

xie_junran@163.com 

研究负责人电子邮件:

Study leader's E-mail:

xie_junran@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:

浙江省杭州市江干区庆春东路3号 

研究负责人通讯地址:

浙江省杭州市江干区庆春东路3号 

Applicant address:

3 Qingchun Road East, Jianggan District, Hangzhou, Zhejiang, China  

Study leader's address:

3 Qingchun Road East, Jianggan District, Hangzhou, 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:

浙江大学医学院附属邵逸夫医院 

Applicant's institution:

Sir Run Run Shaw Hospital,School of Medicine, Zhejiang 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:

20170622-15 

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:

浙江大学附属邵逸夫医院伦理委员会 

Name of the ethic committee:

the ethic committee of Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-06-22 

伦理委员会联系人:

刘利民 

Contact Name of the ethic committee:

Limin Liu 

伦理委员会联系地址:

浙江省杭州市江干区庆春东路3号 

Contact Address of the ethic committee:

3 Qingchun Road East, Jianggan District, Hangzhou, Zhejiang, 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:

浙江大学医学院附属邵逸夫医院 

Primary sponsor:

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University 

研究实施负责(组长)单位地址:

浙江省杭州市江干区庆春东路3号 

Primary sponsor's address:

3 Qingchun Road East, Jianggan District, Hangzhou, 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

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

浙江大学医学院附属邵逸夫医院

具体地址:

浙江省杭州市江干区庆春东路3号

Institution
hospital:

Sir Run Run Shaw Hospital,School of Medicine, Zhejiang University

Address:

3 Qingchun Road East, Jianggan District, Hangzhou, Zhejiang, China

经费或物资来源:

课题经费 

Source(s) of funding:

Project funding 

研究疾病:

肺损伤 

Target disease:

lung injury 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

(1)为前列腺切除机器人辅助手术制定个体化肺保护性通气策略,以期降低术后肺部并发症,加速术后康复,提高患者生存率,节约医疗资源;(2)为预防术后肺部并发症的提供研究方向和依据。  

Objectives of Study:

(1) to develop an individualized pulmonary protective ventilation strategy for RARP patients,in order to reduce the incidence of postoperative pulmonary complications, accelerate postoperative rehabilitation, improve the survival rate, save medical resources; (2) to provide research direction and basis for the prevention of postoperative pulmonary complications.  

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:

年龄大于18岁,机器人辅助前列腺切除术 

Inclusion criteria

adult patients scheduled to undergo RARP in the trendelenburg position 

排除标准:

年龄小于18岁,ASA大于3,BMI大于30,伴随呼吸系统疾病(慢性阻塞性肺疾病史,哮喘,胸科手术史),颅高压,左心射血分数小于30%,术后需入ICU,需要输血,术后肺部以外的感染,拒绝签署知情同意书,同时参加其他临床试验 

Exclusion criteria:

patients less than 18 yr old, an American Society of Anesthesiologists physical status score greater than 3, body mass index (BMI) >30, respiratory comorbidities (clinical evidence or history of chronic obstructive pulmonary disease, interstitial pneumopathies, asthma, previous thoracic surgery), intracranial hypertension, a preoperative left ventricular ejection fraction less than 30%, patients transferred to ICU postoperatively, need transfusion, postoperative infection except pulmonary, refusal to sign the informed consent, participate in other clinical trials. 

研究实施时间:

Study execute time:

From2017-04-01To 2017-11-30 

征募观察对象时间:

Recruiting time:

From2017-04-01To 2017-11-27 

干预措施:

Interventions:

组别:

实验组

样本量:

32

Group:

experimental group

Sample size:

干预措施:

保护性通气

干预措施代码:

Intervention:

protective ventilation

Intervention code:

组别:

对照组

样本量:

32

Group:

control group

Sample size:

干预措施:

传统性通气

干预措施代码:

Intervention:

traditional ventilation

Intervention code:

组别:

最佳PEEP组

样本量:

25

Group:

the optimal peep group

Sample size:

干预措施:

最佳peep

干预措施代码:

Intervention:

optimal peep

Intervention code:

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):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江大学医学院附属邵逸夫医院 

单位级别:

三甲医院 

Institution
hospital:

Sir Run Run Shaw Hospital,School of Medicine, Zhejiang University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

术后住院日

指标类型:

次要指标 

Outcome:

the length of hospital stay

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血气氧合指数

指标类型:

主要指标 

Outcome:

oxygenation index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后肺部并发症评分

指标类型:

次要指标 

Outcome:

mCPIS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

炎症因子

指标类型:

次要指标 

Outcome:

inflammatory factor

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺部并发症

指标类型:

次要指标 

Outcome:

postoperative pulmonary complications

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:

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

符合条件的入选患者在知情同意后,由参与研究的麻醉医生根据随机数表分组:保护性通气组和传统肺保护性通气组。

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

Eligible patients were grouped according to the random number table after informed consent by the anesthesiologist participating in the study: protective ventilation group and traditional ventilation group.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

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个月内公开,临床试验公共管理平台

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

within six mouths after the trial complete via ResMan

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:

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:

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:

 2018-04-12
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