今天是:2019-07-21 星期日

体外膈肌起搏对机械通气患者脱机的影响
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注册号:

Registration number:

ChiCTR1900024096 

最近更新日期:

Date of Last Refreshed on:

2019-07-01 

注册时间:

Date of Registration:

2019-06-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

体外膈肌起搏对机械通气患者脱机的影响 

Public title:

Effect of external diaphragmatic pacing on weaning outcomes in mechanically ventilated patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

体外膈肌起搏对机械通气患者脱机的影响 

Scientific title:

Effect of external diaphragmatic pacing on weaning outcomes in mechanically ventilated 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:

鲍强 

研究负责人:

何志捷 

Applicant:

Qiang Bao 

Study leader:

Zhijie He 

申请注册联系人电话:

Applicant telephone:

+86 18565567817 

研究负责人电话:

Study leader's telephone:

+86 18922182499 

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:

baoq86@163.com 

研究负责人电子邮件:

Study leader's E-mail:

hezhijie2004@126.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:

广州市沿江西路107号 

研究负责人通讯地址:

广州市沿江西路107号 

Applicant address:

107 Yanjiang Road West, Guangzhou, Guangdong, China 

Study leader's address:

107 Yanjiang Road West, Guangzhou, Guangdong, 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:

中山大学孙逸仙纪念医院 

Applicant's institution:

Sun Yat-sen Memorial Hospital, SYSU  

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:

[2019]伦审研第(23)号 

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:

中山大学孙逸仙纪念医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Sun Yat-sen Memorial Hospital, Sun Yat-sen University  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-06 

伦理委员会联系人:

林双秀 

Contact Name of the ethic committee:

Shuangxiu Lin 

伦理委员会联系地址:

广州市沿江西路107号 

Contact Address of the ethic committee:

107 Yanjiang Road West, Guangzhou, Guangdong, 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:

中山大学孙逸仙纪念医院 

Primary sponsor:

Sun Yat-sen Memorial Hospital, Sun Yat-sen University  

研究实施负责(组长)单位地址:

广东省广州市越秀区沿江西路107号 

Primary sponsor's address:

107 Yanjiang Road West, Guangzhou, Guangdong, 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):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

中山大学孙逸仙纪念医院

具体地址:

广州市沿江西路107号

Institution
hospital:

Sun Yat-sen Memorial Hospital, SYSU

Address:

107 Yanjiang Road West, Guangzhou, Guangdong, China

经费或物资来源:

广州雪利昂生物科技有限公司 

Source(s) of funding:

Guangzhou Xueliang Biotechnology Developing Co., Ltd  

研究疾病:

呼吸机相关膈肌功能不全 

Target disease:

Ventilator-induced diaphragmatic dysfunction 

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:

评估体外膈肌起搏在机械通气患者中安全性和对脱机疗效。 

Objectives of Study:

The purpose of this study is to assess the safety and effect of external diaphragmatic pacing on weaning outcomes in mechanically ventilated patients 

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岁; (2)预计机械通气时间≥3天。 

Inclusion criteria

(1) Aged >=18 years; (2) Expected duration of mechanical ventilation >=72 Hours. 

排除标准:

(1)孕妇; (2)血流动力学不稳定、休克; (3)颈髓损伤、神经肌肉疾病病史; (4)具有膈神经麻痹病史; (5)BMI≥40kg/m2; (6)存在经皮膈肌起搏禁忌症(如气胸、安装心脏起搏器); (7)拒绝签字本研究知情同意书。 

Exclusion criteria:

(1) Pregnancy; (2) Hemodynamic instability, shock; (3) Cervical spinal cord injury, neuromuscular disease; (4) Phrenic nerve paralysis; (5) BMI>=40kg/m2; (6) Contraindications of external diaphragmatic pacing such as pneumothorax, presence of cardiac pacemaker; (7) Informed consent rejected. 

研究实施时间:

Study execute time:

From2019-07-01To 2021-06-30 

干预措施:

Interventions:

组别:

试验组

样本量:

80

Group:

Experimental group

Sample size:

干预措施:

体外膈肌起搏

干预措施代码:

Intervention:

External diaphragmatic pacing

Intervention code:

组别:

对照组

样本量:

80

Group:

Control group

Sample size:

干预措施:

常规机械通气流程

干预措施代码:

Intervention:

Routine protocols of mechanical ventilation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

中山大学孙逸仙纪念医院 

单位级别:

三甲 

Institution
hospital:

Sun Yat-sen Memorial Hospital, SYSU  

Level of the institution:

Tertiary A Hospital  

测量指标:

Outcomes:

指标中文名:

脱机成功率

指标类型:

主要指标 

Outcome:

Weaning success rate

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:

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

入选患者按住院时间的先后顺序进行编号,采用随机数字表法分配对照组或试验组。

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

The enrolled patients were numbered according to the order of hospitalization time, and the control group or the experimental group was assigned by random number table method.

盲法:

未说明

Blinding:

Not stated

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):

2021年7月,临床试验公共管理平台ResMan (www.medresman.org)

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

July 2021,www.medresman.org

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:

数据采集采用病例记录表的方式进行,后期应用Microsoft Excel进行统一管理。

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

Data would be collected and recorded by case record form (CRF), and managed by Microsoft Excel.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-06-25
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