今天是:2022-01-25 星期二

上气道超声参数在预测困难气道中的应用
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注册号:

Registration number:

ChiCTR2100053826 

最近更新日期:

Date of Last Refreshed on:

2021-11-30 

注册时间:

Date of Registration:

2021-11-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

上气道超声参数在预测困难气道中的应用 

Public title:

Application of upper airway ultrasonic parameters in predicting difficult airway 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

上气道超声参数在预测困难气道中的应用 

Scientific title:

Application of upper airway ultrasonic parameters in predicting difficult airway 

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:

袁静 

研究负责人:

袁静 

Applicant:

Jing Yuan 

Study leader:

Jing Yuan 

申请注册联系人电话:

Applicant telephone:

13585206556 

研究负责人电话:

Study leader's telephone:

13585206556 

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:

yuanjing198093@163.com 

研究负责人电子邮件:

Study leader's E-mail:

yuanjing198093@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:

南京中大医院麻醉科 

研究负责人通讯地址:

南京中大医院麻醉科 

Applicant address:

Department of Anesthesiology, Nanjing Zhongda Hospital 

Study leader's address:

Department of Anesthesiology, Nanjing Zhongda Hospital 

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:

东南大学附属中大医院 

Applicant's institution:

Zhongda Hospital Southeast 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:

2021ZDSYLL205-P01 

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:

东南大学附属中大医院临床研究伦理委员会 

Name of the ethic committee:

IEC for Clinical Research of Zhongda Hospital ,Affiliated to Southeast University 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-08-30 

伦理委员会联系人:

王慧萍 

Contact Name of the ethic committee:

Huiping Wang 

伦理委员会联系地址:

南京鼓楼区丁家桥87号 

Contact Address of the ethic committee:

No.87 Dingjiaqiao, Gulou District, Nanjing 

伦理委员会联系人电话:

Contact phone of the ethic committee:

025-83272015 

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:

东南大学附属中大医院 

Primary sponsor:

Zhongda Hospital Southeast University 

研究实施负责(组长)单位地址:

南京市丁家桥87号 

Primary sponsor's address:

No.87 Dingjiaqiao, Gulou District, Nanjing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

2020年南京市卫生科技发展专项基金 

Source(s) of funding:

Nanjing Health Science and Technology Development Special Fund in 2020 

研究疾病:

困难气道 

Target disease:

Difficult airway 

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:

探索性研究/预试验 

Study phase:

研究目的:

寻找能有效预测困难气道的上气道超声参数指标,同时建立困难气道预测模型,为临床医生提供新的、可靠的预测困难气道的方法。 

Objectives of Study:

In order to provide clinicians with a new and reliable method to predict difficult airway, we should search for upper airway ultrasound parameters that can effectively predict difficult airway and establish a prediction model of difficult airway. 

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:

1.签署知情同意书,自愿参加本研究; 2.年龄不低于18岁; 3.ASA分级Ⅰ~Ⅱ级。 

Inclusion criteria

1. Signed informed consent and voluntarily participated in the study; 2. >= 18 years old; 3.ASA 1~2 . 

排除标准:

1.颌面部有外伤; 2.颌面部及上气道肿瘤患者; 3.明确气道狭窄病史; 4.研究者判断患者不适合本研究的其他情况。 

Exclusion criteria:

1. Maxillofacial trauma; 2. Maxillofacial and upper airway tumors; 3. Clear history of airway stenosis; 4. The investigator judged that the patient was not suitable for other conditions of the study. 

研究实施时间:

Study execute time:

From2021-12-06To 2022-12-31 

征募观察对象时间:

Recruiting time:

From2021-12-06To 2022-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

700

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

超声参数

指标类型:

主要指标 

Outcome:

ultrasound parameters

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:

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 75 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):

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

no

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

论文发表

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

Papers published

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:

病例记录表

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

Case Record Form

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-11-30
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