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喉罩联合神经阻滞在肋骨骨折内固定手术中应用的观察研究
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注册号:

Registration number:

ChiCTR1900025698 

最近更新日期:

Date of Last Refreshed on:

2019-09-05 

注册时间:

Date of Registration:

2019-09-05 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

喉罩联合神经阻滞在肋骨骨折内固定手术中应用的观察研究 

Public title:

Observational study of non-tracheal anesthesia in internal fixation for rib fractures 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

喉罩联合神经阻滞在肋骨骨折内固定手术中应用的观察研究 

Scientific title:

Observational study of non-tracheal anesthesia in internal fixation for rib fractures 

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:

赵伟刚 

研究负责人:

杨异 

Applicant:

Weigang Zhao 

Study leader:

Yi Yang 

申请注册联系人电话:

Applicant telephone:

+86 18930170427 

研究负责人电话:

Study leader's telephone:

+86 18930177301 

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:

zwg542@163.com 

研究负责人电子邮件:

Study leader's E-mail:

dryangyi12312@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:

上海市徐汇区宜山路600号 

研究负责人通讯地址:

上海市徐汇区宜山路600号 

Applicant address:

600 Yishan Road, Xuhui District, Shanghai, China 

Study leader's address:

600 Yishan Road, Xuhui District, Shanghai, 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:

上海市第六人民医院 

Applicant's institution:

Shanghai Jiao Tong University Affiliated Sixth People's Hospital 

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:

2019-53 

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:

上海市第六人民医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Shanghai Sixth peope's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-05-30 

伦理委员会联系人:

贾伟平 

Contact Name of the ethic committee:

Weiping Jia 

伦理委员会联系地址:

上海市徐汇区宜山路600号 

Contact Address of the ethic committee:

600 Yishan Road, Xuhui District, Shanghai, 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:

上海市第六人民医院 

Primary sponsor:

Shanghai Jiao Tong University Affiliated Sixth People's Hospital 

研究实施负责(组长)单位地址:

上海市徐汇区宜山路600号 

Primary sponsor's address:

600 Yishan Road, Xuhui District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市第六人民医院

具体地址:

上海市徐汇区宜山路600号

Institution
hospital:

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Address:

600 Yishan Road, Xuhui District, Shanghai, China

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

研究疾病:

肋骨骨折 

Target disease:

rib fractures 

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:

观察喉罩联合神经阻滞在肋骨内固定手术中的有效性及安全性 

Objectives of Study:

To assess the feasibility and safety of non-tracheal anesthesia in internal fixation for rib fractures 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

① 单侧单纯肋骨骨折患者 ② 18-70岁 ③ ASA评分I-II级 ④ BMI<30 ⑤ 术前动脉氧分压>60mmHg,二氧化碳分压<50mmHg 

Inclusion criteria

(1) Patients with unilateral rib fracture; (2) 18-70 years old; (3) ASA grade of I–II; (4) BMI < 30; (5) Preoperative partial pressure of arterial oxygen > 60 mmHg and partial pressure of carbon dioxide < 50 mmHg. 

排除标准:

① 困难气道 ② 食管返流史 ③ 重症肌无力 ④ 凝血系统异常 ⑤ 消化道溃疡或出血史 ⑥ 麻醉相关药物过敏史 ⑦ 哮喘或慢性阻塞性肺气肿病史 ⑧ 妊娠期妇女。 

Exclusion criteria:

(1) Difficult airway; (2) History of esophageal reflux; (3) Myasthenia gravis; (4) Abnormal coagulation system; (5) History of gastrointestinal ulcer or bleeding; (6) History of drug allergy related to anesthesia; (7) History of asthma or chronic obstructive pulmonary emphysema; (9) Pregnant women. 

研究实施时间:

Study execute time:

From2019-06-01To 2019-07-31 

征募观察对象时间:

Recruiting time:

From2019-06-01To 2019-08-31 

干预措施:

Interventions:

组别:

无插管组

样本量:

40

Group:

Case series

Sample size:

干预措施:

喉罩+神经阻滞

干预措施代码:

Intervention:

Laryngeal mask combined with nerve block

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 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市第六人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Jiao Tong University Affiliated Sixth People’s Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

术后疼痛评分

指标类型:

主要指标 

Outcome:

Postoperative pain score

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 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):

单臂研究,无随机

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

N/A

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:

即时公开/Real time access

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):

网络平台,网址www.medesman.org

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

network platform,The URL is http://www.medesman.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:

电子采集和管理系统

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

Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-09-05
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