今天是:2020-08-05 星期三

该试验尚未获伦理委员会批准,请于批准后才开始征募参试者,并与我们联系上传伦理批件。 分析超声联合呼吸力学参数在呼吸衰竭患者撤机结局中的价值
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注册号:

Registration number:

ChiCTR2000033997 

最近更新日期:

Date of Last Refreshed on:

2020-06-20 

注册时间:

Date of Registration:

2020-06-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

该试验尚未获伦理委员会批准,请于批准后才开始征募参试者,并与我们联系上传伦理批件。 分析超声联合呼吸力学参数在呼吸衰竭患者撤机结局中的价值 

Public title:

The value of ultrasound combined with respiratory mechanics parameters for withdrawal of invasive ventilation in patients with respiratory failure  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

分析超声联合呼吸力学参数在呼吸衰竭患者撤机结局中的价值 

Scientific title:

The value of ultrasound combined with respiratory mechanics parameters for withdrawal of invasive ventilation in patients with respiratory failure  

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:

李辰 

研究负责人:

李辰 

Applicant:

Chen Li 

Study leader:

Chen Li 

申请注册联系人电话:

Applicant telephone:

+86 13585808910 

研究负责人电话:

Study leader's telephone:

+86 13585808910 

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:

13585808910@163.com 

研究负责人电子邮件:

Study leader's E-mail:

13585808910@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:

上海即墨路149号 

研究负责人通讯地址:

上海即墨路149号 

Applicant address:

149 Jimo Road, Shanghai, China 

Study leader's address:

149 Jimo Road, 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:

上海市东方医院 

Applicant's institution:

Shanghai Oriental Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

上海市东方医院 

Primary sponsor:

Shanghai Oriental Hospital 

研究实施负责(组长)单位地址:

上海即墨路149号 

Primary sponsor's address:

149 Jimo Road, 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):

上海

Country:

China

Province:

Shanghai

City:

Shanghai

单位(医院):

上海市东方医院

具体地址:

上海即墨路149号

Institution
hospital:

Shanghai Oriental Hospital

Address:

149 Jimo Road, Shanghai, China

经费或物资来源:

自筹 

Source(s) of funding:

Self funding 

研究疾病:

呼吸衰竭 

Target disease:

Respiratory failure 

研究疾病代码:

 

Target disease code:

 

研究类型:

预后研究 

Study type:

Prognosis study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

探讨床旁超声评估膈肌功能、肺部通气,并结合呼吸力学参数气道闭合压(P0.1)和呼吸浅快指数(Rapid Shallow Breathing Index,RSBI)在呼吸衰竭患者撤机结局中的价值。 

Objectives of Study:

To investigate the value of bedside ultrasound in evaluating diaphragmatic function, pulmonary ventilation, combined with respiratory mechanics parameters airway closure pressure (P0.1) and Rapid Shallow Breathing Index (RSBI) in the withdrawal outcome of patients with respiratory failure. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

3.2.1所有患者符合自主呼吸实验且顺利通过,完成床边超声检查并记录呼吸力学参数; 3.2.2患者自愿签署知情同意书; 

Inclusion criteria

1. All patients passed the experiment of spontaneous respiration successfully, completed bedside ultrasound examination and recorded respiratory mechanics parameters; 2. Patients voluntarily sign informed consent 

排除标准:

怀疑有膈肌麻痹; 患有神经肌肉病变(格林巴利、重症肌无力)、 气胸或大量胸腔积液、 既往有心脏手术病史或胸膜手术,上气道梗阻、循环不稳定(使用血管活性药物)。 

Exclusion criteria:

1. Patients suspected of phrenic paralysis; 2. Patients with neuromuscular diseases (greenbali, myasthenia gravis); 3. Patients with pneumothorax or massive pleural effusion; 4. Patients with previous history of heart operation or pleura operation, upper airway obstruction and unstable circulation (using vasoactive drugs). 

研究实施时间:

Study execute time:

From2020-07-01To 2021-06-30 

征募观察对象时间:

Recruiting time:

From2020-07-01To 2021-06-30 

干预措施:

Interventions:

组别:

拔管成功组

样本量:

25

Group:

Extubation success group

Sample size:

干预措施:

超声评估

干预措施代码:

Intervention:

Ultrasound evaluation

Intervention code:

组别:

拔管失败组

样本量:

25

Group:

Extubation failure group

Sample size:

干预措施:

超声评估

干预措施代码:

Intervention:

Ultrasound evaluation

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(区县):

上海 

Country:

China 

Province:

Shanghai 

City:

Shanghai 

单位(医院):

上海市东方医院 

单位级别:

三甲医院 

Institution
hospital:

Shanghai Oriental Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

拔管成功率

指标类型:

主要指标 

Outcome:

Extubation success rate

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

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

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 / 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):

不涉及随机

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

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

Public database

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:

数据采集由书面形式采集,并手工录入数据库,原始记录存档。相关临床研究数据系统由我院信息部门自行研发并对全院职工免费开放。

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

Data is collected in written form and manually transfered into the database. The original records are stored. The clinical research data system is developed by the information technology department of our hospital and is accessible to all the employees with no charge.

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-06-20
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