今天是:2019-12-12 星期四

气道压力释放通气对心胸外科患者术后肺部并发症发生率的影响
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注册号:

Registration number:

ChiCTR1900020926 

最近更新日期:

Date of Last Refreshed on:

2019-01-22 

注册时间:

Date of Registration:

2019-01-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

气道压力释放通气对心胸外科患者术后肺部并发症发生率的影响 

Public title:

Effect of airway pressure release ventilation on the incidence of postoperative pulmonary complications in patients undergoing cardiothoracic surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

气道压力释放通气对心胸外科患者术后肺部并发症发生率的影响 

Scientific title:

Effect of airway pressure release ventilation on the incidence of postoperative pulmonary complications in patients undergoing cardiothoracic surgery 

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:

段开亮 

研究负责人:

段开亮 

Applicant:

Kailiang Duan 

Study leader:

Kailiang Duan 

申请注册联系人电话:

Applicant telephone:

+86 13958124245 

研究负责人电话:

Study leader's telephone:

+86 13958124245 

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:

aliang-11@163.com 

研究负责人电子邮件:

Study leader's E-mail:

aliang-11@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:

浙江省杭州市庆春东路3号 

研究负责人通讯地址:

浙江省杭州市庆春东路3号 

Applicant address:

3 Qingchun Road East, Hangzhou, Zhejiang, China 

Study leader's address:

3 Qingchun Road East, 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, Medical College of 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:

科研20181225-6 

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:

浙江大学医学院附属邵逸夫医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Sir Run Run Shaw Hospital,Medical College of Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-02 

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:

浙江省杭州市庆春东路3号 

Contact Address of the ethic committee:

3 Qingchun Road East, 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, Medical College of Zhejiang University 

研究实施负责(组长)单位地址:

浙江省杭州市庆春东路3号 

Primary sponsor's address:

3 Qingchun Road East, 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:

浙江省杭州市庆春东路3号

Institution
hospital:

Sir Run Run Shaw Hospital,Medical College of Zhejiang University

Address:

No. 3 Qingchun East Road, Hangzhou, Zhejiang, China

经费或物资来源:

浙江大学医学院附属邵逸夫医院 

Source(s) of funding:

Sir Run Run Shaw Hospital, Medical College of Zhejiang University 

研究疾病:

心胸外科 

Target disease:

Cardiothoracic surgery 

研究疾病代码:

 

Target disease code:

 

研究类型:

预后研究 

Study type:

Prognosis 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:

明确不同机械通气模式对心胸外科患者术后并发症发生率和预后的影响 

Objectives of Study:

To determine the effects of different mechanical ventilation modes on the incidence of postoperative complications and prognosis in patients undergoing cardiothoracic 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:

1. 年龄18-60岁; 2. 在我院接受心胸外科手术治疗; 3. 术后需要有创机械通气。 

Inclusion criteria

1. Aged 18 to 60 years; 2. Received cardiothoracic surgery in our hospital; 3. Invasive mechanical ventilation is required postoperatively. 

排除标准:

1. 孕妇; 2. 手术后患者循环不稳定,收缩压<80mmHg或心率>130bpm; 3. 手术后PaO2/FiO2<100; 4. 气道阻塞性疾病; 5. 拒绝入组。 

Exclusion criteria:

1. Pregnant women; 2. The patient's circulation is unstable, with systolic blood pressure < 80mmHg or heart rate > 130bpm; 3. PaO2/FiO2<100 after surgery; 4. Airway obstructive disease; 5. Refuse to be enrolled. 

研究实施时间:

Study execute time:

From2019-02-01To 2019-12-31 

干预措施:

Interventions:

组别:

实验组

样本量:

30

Group:

experimental group

Sample size:

干预措施:

使用气道压力释放通气模式支持患者

干预措施代码:

Intervention:

Use airway pressure release ventilation mode to support the patient

Intervention code:

组别:

对照组

样本量:

30

Group:

control group

Sample size:

干预措施:

使用辅助/控制通气模式支持患者

干预措施代码:

Intervention:

Use assist/ control mode to support the patient

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:

三级甲等 

Institution
hospital:

Sir Run Run Shaw Hospital,Medical College of Zhejiang University  

Level of the institution:

Tertiary A hospital 

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 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:

肺内气体分布

指标类型:

次要指标 

Outcome:

The gas distribution of lung

Type:

Secondary indicator 

测量时间点:

入组后1小时

测量方法:

电阻抗成像

Measure time point of outcome:

1 hour after enrollment

Measure method:

Electrical Impedance Tomography

指标中文名:

30天后生死亡率

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:

机械通气时间

指标类型:

次要指标 

Outcome:

Duration of mechanical ventilation

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:

肺泡灌洗液

组织:

Sample Name:

Bronchoalveolar Lavage Fluid

Tissue:

lung

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 60 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):

研究负责人根据随机数表产生随机序列。

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

Study leader generates random sequence according to the random number table.

盲法:

N/A

Blinding:

N/A

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:

试验完成后6个月内公开/Within six months after the trial complete

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):

临床试验公共管理平台,http://www.medresman.org/login.aspx

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

Research Manager,http://www.medresman.org/login.aspx

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:

使用excel表格记录数据

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

using excel

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-01-22
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