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: |
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English Acronym: |
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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: |
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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: |
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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): |
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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: |
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申请人所在单位: |
上海市第六人民医院 |
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Applicant's institution: |
Shanghai Jiao Tong University Affiliated Sixth People's Hospital |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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 |
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Name of the ethic committee: |
Ethics Committee of Shanghai Sixth peope's Hospital |
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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 |
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Contact Name of the ethic committee: |
Weiping Jia |
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伦理委员会联系地址: |
上海市徐汇区宜山路600号 |
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Contact Address of the ethic committee: |
600 Yishan Road, Xuhui District, Shanghai, China |
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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 |
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Primary sponsor: |
Shanghai Jiao Tong University Affiliated Sixth People's Hospital |
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研究实施负责(组长)单位地址: |
上海市徐汇区宜山路600号 |
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Primary sponsor's address: |
600 Yishan Road, Xuhui District, Shanghai, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
自筹 |
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Source(s) of funding: |
Self-financing |
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研究疾病: |
肋骨骨折 |
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Target disease: |
rib fractures |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
探索性研究/预试验 | ||||||||||||||||||||||
Study phase: |
0 |
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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 |
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Objectives of Study: |
To assess the feasibility and safety of non-tracheal anesthesia in internal fixation for rib fractures |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
单臂 |
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Study design: |
Single arm |
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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 |
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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. |
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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。 |
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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: |
从From2019-06-01至To 2019-07-31 |
征募观察对象时间: Recruiting time: |
从From2019-06-01至To 2019-08-31 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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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 |
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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): |
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Calculated Results after
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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 |