Today is 2022-01-23

Effect of preventive ACP-oriented protective ventilation on the prognosis of ARDS patients
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注册号:

Registration number:

ChiCTR2200055644 

最近更新日期:

Date of Last Refreshed on:

2022-01-15 

注册时间:

Date of Registration:

2022-01-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

预防ACP导向的保护性通气对ARDS患者预后的影响 

Public title:

Effect of preventive ACP-oriented protective ventilation on the prognosis of ARDS patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

预防ACP导向的保护性通气对ARDS患者预后的影响 

Scientific title:

Effect of preventive ACP-oriented protective ventilation on the prognosis of ARDS patients 

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:

鹿中华 

研究负责人:

鹿中华 

Applicant:

Lu zhonghua 

Study leader:

Lu zhonghua 

申请注册联系人电话:

Applicant telephone:

13515602553 

研究负责人电话:

Study leader's telephone:

13515602553 

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:

luzhonghua077@126.com 

研究负责人电子邮件:

Study leader's E-mail:

luzhonghua077@126.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:

合肥市芙蓉路678号 

研究负责人通讯地址:

合肥市芙蓉路678号 

Applicant address:

678 Furong Road, Hefei, Anhui Province , China 

Study leader's address:

678 Furong Road, Hefei, Anhui Province , 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:

安徽医科大学第二附属医院 

Applicant's institution:

the Second Affiliated Hospital, Anhui Medical 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:

YX2021-136 

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:

安徽医科大学第二附属医院医学研究伦理委员会 

Name of the ethic committee:

the Second Hospital of Anhui Medical University, Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

张静 

Contact Name of the ethic committee:

Zhang Jing 

伦理委员会联系地址:

合肥市芙蓉路678号 

Contact Address of the ethic committee:

678 Furong Road, Hefei, Anhui Province , 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:

安徽医科大学第二附属医院 

Primary sponsor:

the Second Affiliated Hospital, Anhui Medical University 

研究实施负责(组长)单位地址:

合肥市芙蓉路678号 

Primary sponsor's address:

678 Furong Road, Hefei, Anhui Province , 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):

安徽省

市(区县):

Country:

China

Province:

Anhui

City:

单位(医院):

安徽医科大学第二附属医院

具体地址:

合肥市芙蓉路678号

Institution
hospital:

the Second Hospital of Anhui Medical University

Address:

678 Furong Road, Hefei, Anhui Province , China

经费或物资来源:

安徽医科大学第二附属医院临床计划孵育项目 

Source(s) of funding:

Clinical planning incubation project of the Second Affiliated Hospital of Anhui Medical University 

研究疾病:

急性呼吸窘迫综合征 

Target disease:

acute respiratory distress syndrome 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

预防ACP导向的保护性通气对ARDS患者预后的影响 

Objectives of Study:

预防ACP导向的保护性通气对ARDS患者预后的影响 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1) 符合柏林定义诊断标准的中重度ARDS患者: 2)气管插管机械通气时间小于48小时; 3)年龄≥18岁。 

Inclusion criteria

1) Patients with moderate to severe ARDS who meet the diagnostic criteria defined by Berlin: 2) Mechanical ventilation time of endotracheal intubation is less than 48 hours; 3) Age ≥18. 

排除标准:

1) 重度阻塞性肺部疾病; 2) 肺大泡或气胸、皮下气肿、纵隔气肿; 3) 妊娠; 4) BMI≥35kg/m2; 5) 怀疑肺血管性出血; 6) 濒死状态或疾病终末期; 7)神经肌肉病变; 8) 血液系统恶性肿瘤、骨髓移植; 9) 心脏功能严重障碍(纽约心脏病协会III 级或IV级,急性冠状动脉综合征或持续性室性快速性心律失常),心源性休克或心脏大手术后; 10) 顽固性休克 (尽管充分液体复苏,使用大剂量血管活性药物:去甲肾上腺素等效剂 量>1ug/kg/min,MAP仍<60mmHg); 11) 未签署知情同意. 

Exclusion criteria:

1) Severe obstructive pulmonary disease; 2) pulmonary bullae or pneumothorax, subcutaneous emphysema, mediastinal emphysema; 3) pregnancy; 4) BMI less than 35 kg/m2 5) Suspected pulmonary vascular hemorrhage; 6) dying or terminal illness; 7) Neuromyopathy; 8) Hematological malignancies, bone marrow transplantation; 9) Severe cardiac dysfunction (New York Heart Association Class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmias), cardiogenic shock or major cardiac surgery; 10) Refractory shock (MAP <60mmHg despite full fluid resuscitation with high dose of vasoactive drugs: norepinephrine equivalent dose >1ug/kg/min); 11) Failure to sign informed consent. 

研究实施时间:

Study execute time:

From2022-01-01To 2024-12-31 

征募观察对象时间:

Recruiting time:

From2022-01-15To 2024-12-31 

干预措施:

Interventions:

组别:

对照组

样本量:

113

Group:

control group

Sample size:

干预措施:

保护性小潮气量通气

干预措施代码:

Intervention:

Protective low tidal volume ventilation

Intervention code:

组别:

实验组

样本量:

113

Group:

experimental group

Sample size:

干预措施:

保护性小潮气量+右心监测指导参数设置

干预措施代码:

Intervention:

Protective low tide volume and right center monitoring guide parameter setting

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

安徽 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

安医大二附院 

单位级别:

三甲 

Institution
hospital:

the Second Affiliated Hospital, Anhui Medical University  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

ICU死亡率

指标类型:

主要指标 

Outcome:

ICU mortality

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:

痰液

组织:

Sample Name:

sputum

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 80 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):

每个信封包含一个数字,使用计算机设计生成的随机块进行随机分配

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

Each envelope contained a number by a random allocation process using a com- puter-generated random block design.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

No

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):

不共享

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

NA

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(Case Record Form, CRF)

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

Case Record Form, CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-01-15
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