今天是:2020-04-08 星期三

皮罗序列征婴儿下颌骨牵引术后标准化气管拔管流程的建立:基于病历记录的回顾性研究
下载XML文档

注册号:

Registration number:

ChiCTR2000031260 

最近更新日期:

Date of Last Refreshed on:

2020-03-26 

注册时间:

Date of Registration:

2020-03-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

皮罗序列征婴儿下颌骨牵引术后标准化气管拔管流程的建立:基于病历记录的回顾性研究 

Public title:

A Standardized Extubation schedule following Mandibular Distraction in Infants:?a retrospective study based on medical records 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

皮罗序列征婴儿下颌骨牵引术后标准化气管拔管流程的建立:基于病历记录的回顾性研究 

Scientific title:

A Standardized Extubation schedule following Mandibular Distraction in Infants:?a retrospective study based on medical records 

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:

张娜 

研究负责人:

徐颖怡 

Applicant:

Na Zhang 

Study leader:

Yingyi Xu 

申请注册联系人电话:

Applicant telephone:

+86 13560409867 

研究负责人电话:

Study leader's telephone:

13632324394 

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:

na999666@163.com 

研究负责人电子邮件:

Study leader's E-mail:

513438980@qq.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:

广东省广州市越秀区人民中路318号 

研究负责人通讯地址:

广东省广州市越秀区人民中路318号 

Applicant address:

318 Middle Renmin Road, Yuexiu District, Guangzhou, Guangdong, China  

Study leader's address:

318 Middle Renmin Road, Yuexiu District, 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:

广州市妇女儿童医疗中心 

Applicant's institution:

Guangzhou Women and Children's Medical Center  

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:

2018101103 

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:

广州市妇女儿童医疗中心科研伦理委员会 

Name of the ethic committee:

Guangzhou Women and Children's Medical Center Institutional Review Board  

伦理委员会批准日期:

Date of approved by ethic committee:

2018-10-17 

伦理委员会联系人:

李庆丰 

Contact Name of the ethic committee:

Li Qingfeng 

伦理委员会联系地址:

广州市金穗路9号 

Contact Address of the ethic committee:

9 Jinsui Road, Tianhe District, Guangzhou, 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:

广州市妇女儿童医疗中心 

Primary sponsor:

Guangzhou Women and Children's Medical Center  

研究实施负责(组长)单位地址:

广州市金穗路9号 

Primary sponsor's address:

9 Jinsui Road, Tianhe District, 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

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州市妇女儿童医疗中心

具体地址:

金穗路9号

Institution
hospital:

Guangzhou Women and Children's Medical Center

Address:

9 Jinsui Road, Tianhe District

经费或物资来源:

无 

Source(s) of funding:

no 

研究疾病:

皮罗氏序列征 

Target disease:

Pierre Robin syndrome  

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

评估标准化气管拔管流程实施对皮罗氏序列征婴儿下颌骨牵引成骨术后临床结局的影响。 

Objectives of Study:

The optimal duration of intubation during early mandibular distraction osteogenesis activation, are poorly understood. This study assesses for differences of clinical outcome following mandibular distraction osteogenesis (MDO) in infants before and after implementation of a standardized extubation protocol.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

2016年11月至2020年2月在广州市妇女儿童医疗中心择期行下颌骨牵引成骨术的皮罗氏序列征婴儿。 

Inclusion criteria

Patients with PRS who underwent MDO at Guangzhou Womens and Children’s Medical Center between November 2016 and January of 2020 were identified. 

排除标准:

病历资料不全者。 

Exclusion criteria:

Patients with incomplete records were excluded. 

研究实施时间:

Study execute time:

From2020-03-23To 2021-01-31 

干预措施:

Interventions:

组别:

case series

样本量:

148

Group:

case series

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

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):

广州市妇女儿童医疗中心 

单位级别:

三甲医院 

Institution
hospital:

Guangzhou Women and Children Medical Center  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

拔管后的呼吸事件

指标类型:

主要指标 

Outcome:

respiratory events after extubation

Type:

Primary indicator 

测量时间点:

拔管后

测量方法:

观察

Measure time point of outcome:

after extubation

Measure method:

observation

指标中文名:

住院时间

指标类型:

主要指标 

Outcome:

postoperative length of stay

Type:

Primary indicator 

测量时间点:

术后

测量方法:

观察

Measure time point of outcome:

Postoperative

Measure method:

observation

指标中文名:

机械通气持续时间

指标类型:

副作用指标 

Outcome:

duration of mechanical ventilation

Type:

Adverse events 

测量时间点:

术后

测量方法:

观察

Measure time point of outcome:

Postoperative

Measure method:

observation

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 0.1 years
最大 Max age 1 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):

回顾性研究,无法随机

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

Retrospective study, not randomized

盲法:

数据统计人员不知道具体的研究对象分组。

Blinding:

The data statisticians don't know the specific study group.

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):

原始数据在试验完成后6个月内公开,采用临床试验公共平台管理和公布 ResMan, http://www.medresman.org.cn。

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

Original data will be shared 6 month after the trial complete on the clinical trial public platform, ResMan, http://www.medresman.org.cn.

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:

试验结束后,纸质病例记录表存放在麻醉科资料室,由专人管理。电子数据保存于麻醉科专用电脑,由专人处理

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

Data are collected by researcher of this program and special researcher assistant. After the study, Printing CRFs will be locked in reference room of anesthesiology department and managed by researchers.Electronic data will be saved in the data bank of anesthesiology department and only can be contacted by special researcher

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-26
返回列表