今天是:2021-10-24 星期日

张成密医师:请尽快上传伦理审批文件并填写伦理委员会联系人。 驱动压导向呼气末正压滴定的个体化肺保护性通气策略对术后肺部并发症的影响
下载XML文档

注册号:

Registration number:

ChiCTR-IOR-16008900 

最近更新日期:

Date of Last Refreshed on:

2020-05-25 

注册时间:

Date of Registration:

2016-07-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

张成密医师:请尽快上传伦理审批文件并填写伦理委员会联系人。 驱动压导向呼气末正压滴定的个体化肺保护性通气策略对术后肺部并发症的影响 

Public title:

The effects of individualized lung-protective ventilation with driving pressure-guided Positive end-expiratory pressure titration on postoperative pulmonary complications 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

驱动压导向的个体化呼气末正压在上腹部手术中的应用 

Scientific title:

Driving Pressure-guided Individualized Positive End-expiratory Pressure During Abdominal Surgery: A Randomized Controlled Trial 

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:

张成密 

研究负责人:

石学银 

Applicant:

Chengmi Zhang 

Study leader:

Xueyin Shi 

申请注册联系人电话:

Applicant telephone:

+86 13795250221 

研究负责人电话:

Study leader's telephone:

+86 021-25078999 

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:

zhcm1985@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

shixueyin1128@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:

上海市杨浦区控江路1665号,新华医院麻醉与重症医学科 

研究负责人通讯地址:

上海市杨浦区控江路1665号,新华医院麻醉与重症医学科 

Applicant address:

Department of Anesthesiology, Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, 1665 Kongjiang Road, Shanghai 

Study leader's address:

Department of Anesthesiology, Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, 1665 Kongjiang Road, Shanghai 

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:

上海交通大学医学院附属新华医院 

Applicant's institution:

Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China. 

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:

XHEC-D-2016-037 

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:

上海交通大学医学院附属新华医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-07-20 

伦理委员会联系人:

No stated 

Contact Name of the ethic committee:

No stated 

伦理委员会联系地址:

上海市杨浦区控江路1665号新华医院伦理委员会办公室 

Contact Address of the ethic committee:

1665 Kongjiang Road Shanghai, Yangpu District, 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:

上海交通大学医学院附属新华医院 

Primary sponsor:

Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China. 

研究实施负责(组长)单位地址:

上海市杨浦区控江路1665号,新华医院麻醉与重症医学科 

Primary sponsor's address:

Department of Anesthesiology, Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, 1665 Kongjiang Road, Shanghai 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院附属新华医院

具体地址:

上海市杨浦区控江路1665号

Institution
hospital:

Xinhua Hospital, School of Medicine, Shanghai Jiaotong University

Address:

1665 Kongjiang Road, Shanghai 200092, China

经费或物资来源:

自筹 

Source(s) of funding:

self-financing 

研究疾病:

肺损伤 

Target disease:

lung damage 

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:

探讨驱动压导向PEEP滴定的个体化肺保护通气策略对全麻开腹手术患者术后肺部并发症及预后的影响。 

Objectives of Study:

This study aimed to evaluate the impact of individualized PEEP guided by driving pressure as compared with conventional fixed PEEP of 6 cmH2O, applied during the intraoperative period, on PPCs in patients with intermediate-to-high risk of developing PPCs, who underwent major open upper abdominal surgery. 

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:

在上海交通大学医学院附属新华医院行上腹部开腹手术的预计PPCs中高危患者,年龄18-80岁,ASA II-III级,BMI<35kg/m2,预计手术时间>2h。 

Inclusion criteria

ASA II-III status patients scheduled for open upper abdominal surgery expected to last more than 2 h under general anesthesia, who had intermediate-to-high risk of developing PPCs (as defined by the ARISCAT score), and patients aged 18-80 yrs, and Body-mass index (BMI) less than 35 kg/m2.. 

排除标准:

1)拒绝参与实验,不签知情同意书者;2)患者近4周有上感症状或肺部感染症状疾病;3)术前有胸腔积液;4)有影响胸廓顺应性的胸肺相关疾病如鸡胸、漏斗胸和桶状胸、胸部外伤、哮喘、肺气肿、间质性肺疾病等;5)有神经肌肉功能障碍病史;6)有严重心血管事件、肺、肾及造血系统疾病等;7)BMI > 35kg/m2。 

Exclusion criteria:

1.Patients with a history of upper respiratory tract or pulmonary infection within 4 weeks before surgery; 2.Pleural effusion; 3.Chest- and lung-associated diseases; 4.Neuromuscular dysfunction; 5.Serious cardiovascular, lung, kidney, and hematopoietic diseases; 

研究实施时间:

Study execute time:

From2016-07-26To 2019-03-31 

征募观察对象时间:

Recruiting time:

From2017-04-01To 2019-03-31 

干预措施:

Interventions:

组别:

驱动压导向PEEP组

样本量:

74

Group:

driving pressure guided PEEP setting

Sample size:

干预措施:

依据驱动压改变PEEP

干预措施代码:

Intervention:

change PEEP based on driving pressure

Intervention code:

组别:

传统固定PEEP组

样本量:

74

Group:

Conventional fixed PEEP

Sample size:

干预措施:

固定PEEP为6cmH2O

干预措施代码:

Intervention:

Standard fixed PEEP at 6 cmH2O

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学医学院附属新华医院 

单位级别:

三级甲等 

Institution
hospital:

Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

术后肺部并发症发生率

指标类型:

主要指标 

Outcome:

Incidence of clinically significent postoperative pulmonary complications

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

30天死亡率

指标类型:

次要指标 

Outcome:

30-day mortality

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后住院时间

指标类型:

次要指标 

Outcome:

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:

ICU入住率

指标类型:

次要指标 

Outcome:

ICU occupancy rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺部并发症严重性

指标类型:

次要指标 

Outcome:

severity of postoperative pulmonary complications

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

严重肺部并发症发生率

指标类型:

次要指标 

Outcome:

Incidence of severe postoperative pulmonary complications

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后肺不张严重程度

指标类型:

次要指标 

Outcome:

Severity of atelectasis

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后胸腔积液严重程度

指标类型:

次要指标 

Outcome:

Severity of pleural effusion

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后肺部并发症种类

指标类型:

附加指标 

Outcome:

Category of postoperative pulmonary complications

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

机械通气参数

指标类型:

附加指标 

Outcome:

Parameters of ventilation

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸功能参数

指标类型:

附加指标 

Outcome:

Parameters of respiratory function

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心血管功能参数

指标类型:

附加指标 

Outcome:

Parameters of cardiovascular function

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

炎症指标

指标类型:

附加指标 

Outcome:

Inflammatory index

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生化参数

指标类型:

附加指标 

Outcome:

Blood biochemical parameters

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血气参数

指标类型:

附加指标 

Outcome:

Blood gas parameters

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

麻醉监护参数

指标类型:

附加指标 

Outcome:

Anesthetic monitoring parameters

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后镇痛程度

指标类型:

附加指标 

Outcome:

Postoperative analgesia

Type:

Additional 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):

计算机随机分组

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

computer-generated random numbers

盲法:

Blinding:

是否共享原始数据:

IPD sharing

是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):

中国临床试验注册中心,http://www.chictr.org.cn/showproj.aspx?proj=9624

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

Chinese Clinical Trial Registry: http://www.chictr.org.cn/showproj.aspx?proj=9624

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:

数据保存在该部门专用计算机上,并由专人负责管理。

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

We store all dates to the specil computers with experiments,and mange it with designated person.

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:

 2016-07-25
返回列表