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A study on the correlation between the motion and thickening fraction of diaphragmatic and TOFR of adductor pollicis
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注册号:

Registration number:

ChiCTR2000033277 

最近更新日期:

Date of Last Refreshed on:

2020-05-26 

注册时间:

Date of Registration:

2020-05-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

膈肌动度及厚度变化率与拇内收肌TOFR的相关性研究 

Public title:

A study on the correlation between the motion and thickening fraction of diaphragmatic and TOFR of adductor pollicis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

膈肌动度及厚度变化率与拇内收肌TOFR的相关性研究 

Scientific title:

A study on the correlation between the motion and thickening fraction of diaphragmatic and TOFR of adductor pollicis 

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:

陈莲华 

研究负责人:

陈莲华 

Applicant:

Lianhua Chen 

Study leader:

Lianhua Chen 

申请注册联系人电话:

Applicant telephone:

+86 13818945841 

研究负责人电话:

Study leader's telephone:

+86 13818945841 

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:

spinny8898@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

spinny8898@sina.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:

上海市松江区新松江路650号 

研究负责人通讯地址:

上海市松江区新松江路650号 

Applicant address:

650 Xinsongjiang Road, Songjiang District, Shanghai, China 

Study leader's address:

650 Xinsongjiang Road, Songjiang 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:

上海市第一人民医院 

Applicant's institution:

Shanghai General 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:

2019KY070 

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:

上海市第一人民医院人体试验伦理审查委员会 

Name of the ethic committee:

Ethical Committee of Shanghai General Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-12-26 

伦理委员会联系人:

江一峰 

Contact Name of the ethic committee:

Yifeng Jiang 

伦理委员会联系地址:

上海市虹口区武进路86号行政楼317室 

Contact Address of the ethic committee:

Room 317, Xingzheng Building, 86 Wujin Road, Hongkou 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:

上海市第一人民医院麻醉科 

Primary sponsor:

Department of Anesthesiology, Shanghai General Hospital  

研究实施负责(组长)单位地址:

上海市松江区新松江路650号麻醉科 

Primary sponsor's address:

Department of Anesthesiology, 650 Xinsongjiang Road, Songjiang 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):

上海市第一人民医院

具体地址:

虹口区武进路85/86号

Institution
hospital:

Shanghai General Hospital

Address:

86 Wujin Road, Hongkou District

经费或物资来源:

蛇牌学院科学研究基金 

Source(s) of funding:

Science Research Foundation of AESCULAP 

研究疾病:

肌松残余 

Target disease:

Residual muscle relaxation 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

通过超声评估膈肌功能,分析手术及麻醉等多因素对膈肌功能的影响。 通过膈肌动度及膈肌厚度变化率同拇内收肌TOFR的相关关系,分析超声评估膈肌功能判断术后肌松残余的临床应用价值。 

Objectives of Study:

The motion and thickening fraction of diaphragmatic is evaluated by ultrasound, and the influence of operation and anesthesia on diaphragm function is analyzed. Through the correlation between the motion and thickening fraction of diaphragmatic and tofr of adductor pollicis, the clinical application value of evaluating the function of diaphragmatic muscle by ultrasonography was analyzed.  

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:

非心胸及上腹部手术患者, ASA Ⅰ-Ⅱ级,年龄25~65岁, 预计手术时间<3小时,预计手术出血量<5ml/kg。 

Inclusion criteria

1. Non cardiothoracic and upper abdominal surgery patients, 2. ASA I - II patients aged 25-65 years; 3. For the patients whose operation time is less than 3 hours, the bleeding volume is less than 5 ml / kg. 

排除标准:

患有心血管系统疾病; 有严重肝肾功能障碍; 有神经肌肉疾病; 有呼吸系统急慢性疾病及胸廓畸形; 有慢性代谢性疾病; 有胸腹腔积液或影响膈肌功能的肿瘤; 术前肺功能检查异常(FEV1/FVC<70%;FEV1<80%预计值); 术前使用可能影响神经肌肉传导的药物; 3个月内肌松监测部位有外伤手术者; 胸腹壁超声检查部位皮肤有感染破损; 未签署知情同意书。除外孕产妇。 

Exclusion criteria:

1. Patients with cardiovascular diseases; 2. Patients with severe hepatorenal dysfunction; 3. Patients with neuromuscular diseases; 4. Patients with acute and chronic respiratory diseases and thoracic deformity; 5. Patients with chronic metabolic diseases; 6. Patients with pleural effusion or tumor affecting diaphragm function; 7. Patients with abnormal preoperative pulmonary function (FEV1 / FVC < 70%; FEV1 < 80% predicted value); 8. Patients who use drugs that may affect neuromuscular conduction before operation; 9. Patients with trauma operation in the monitoring site of muscle relaxation within 3 months; 10. Patients with skin infection and damage at the chest and abdominal wall ultrasonic examination site; 11. Patients without informed consent. 12. Pregnant women. 

研究实施时间:

Study execute time:

From2020-05-31To 2021-12-31 

诊断措施:

Diagnostic measures:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

诊断肌松残余的金标准TOF<0.9

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

TOF < 0.9

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

膈肌动度及膈肌厚度变化率

Index test:

The motion and thickening fraction of diaphragmatic (DIA, TF).

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

计划行非心胸及上腹部手术者

例数:

Sample size:

200

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Non cardiothoracic and upper abdominal surgery patients.

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市第一人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai General Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

膈肌动度

指标类型:

主要指标 

Outcome:

motion of diaphragmatic

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

膈肌厚度变化率

指标类型:

主要指标 

Outcome:

thickening fraction of diaphragmatic

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

TOFr

指标类型:

主要指标 

Outcome:

TOFr

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SEN, SPE, ACC, AUC of ROC

指标类型:

主要指标 

Outcome:

SEN, SPE, ACC, AUC of ROC

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:

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 25 years
最大 Max age 65 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):

未使用

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

Not used

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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12月,电子表格录入, 中国临床试验数注册中心

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

December 2021, manual input spreadsheet, China clinical trials registration center (www.chictr.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:

填写病例记录表;试验数据通过电子采集和管理系统管理。

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

Fill in Case Record Form; Test data is managed by Electronic Data Capture.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-05-26
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