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A study on the compliance and effectiveness of nursing exercise intervention on prone positioning in patients with mild and common COVID-19
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注册号:

Registration number:

ChiCTR2200055638 

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:

请于伦理委员会批准后才开始征募参试者,并与我们联系上传伦理批件。 护理运动干预对轻型及普通型新冠患者俯卧位通气的依从性和有效性研究 

Public title:

A study on the compliance and effectiveness of nursing exercise intervention on prone positioning in patients with mild and common COVID-19 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

护理运动干预对轻型及普通型新冠患者俯卧位通气的依从性和有效性研究 

Scientific title:

A study on the compliance and effectiveness of nursing exercise intervention on prone positioning in patients with mild and common COVID-19 

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:

吴颖 

研究负责人:

蒋艳 

Applicant:

Ying Wu 

Study leader:

Yan Jiang 

申请注册联系人电话:

Applicant telephone:

18980606932 

研究负责人电话:

Study leader's telephone:

18980601511 

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:

358383278@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

hxhljy2018@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:

四川省成都市武侯区国学巷37号四川大学华西医院 

研究负责人通讯地址:

四川省成都市武侯区国学巷37号四川大学华西医院行政楼 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

610041 

研究负责人邮政编码:

Study leader's postcode:

610041 

申请人所在单位:

四川大学华西医院 

Applicant's institution:

West China Hospital of Sichuan University  

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:

四川大学华西医院 

Primary sponsor:

West China Hospital of Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市武侯区国学巷37号四川大学华西医院行政楼 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

四川省成都市武侯区国学巷37号四川大学华西医院

Institution
hospital:

West China Hospital of Sichuan University

Address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China

经费或物资来源:

四川省卫生健康委员会医学重大创新项目(20ZDCX002) 

Source(s) of funding:

Sichuan Health Care Commission Medical Major Innovation Project(20ZDCX002) 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

Novel coronavirus pneumonia (COVID-19)  

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:

探索与常规俯卧位通气相比,联合护理运动干预对轻型及普通型新冠患者病情变化、呼吸状态、肺部情况以及其他临床结局的影响,以及评估俯卧位通气的依从性。 

Objectives of Study:

To explore the effect of combined nursing exercise interventions on changes in condition, respiratory status, lung condition and other clinical outcomes in patients with mild and common COVID-19 compared to routine prone positioning, and to assess adherence to prone posotioning. 

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 已确诊为轻型或普通型的新型冠状肺炎感染患者。 ② 年龄≥18岁。 ③ 神志清楚,有自主言语表达能力。 ④ 自主呼吸,能配合本实验者。 

Inclusion criteria

① Patients with confirmed mild or common form of novel coronary pneumonia infection. ② Age ≥ 18 years. ③ Clear consciousness, with the ability to express themselves verbally. ④ Those who breathe spontaneously and can cooperate with this experiment. 

排除标准:

① 危重患者(有创机械通气、严重心力衰竭或血流动力学不稳定)。 ② 有俯卧位禁忌证((如近期腹部或胸部手术或外伤,面部、骨盆或脊柱骨折,未经治疗的气胸等)。 ③ 因严重精神病、认知障碍等原因无法配合。 ④ 孕妇、哺乳期妇女。 ⑤ 在试验期间参加其他形式的锻炼的患者。  

Exclusion criteria:

① Patients who are critically ill (invasive mechanical ventilation, severe heart failure or haemodynamic instability). ② Contraindications to prone positioning ((e.g. recent abdominal or thoracic surgery or trauma, facial, pelvic or spinal fractures, untreated pneumothorax, etc.). ③ Unable to cooperate due to severe mental illness, cognitive impairment, etc. ④ Pregnant or breastfeeding women. ⑤ Patients who participate in other forms of exercise during the trial.  

研究实施时间:

Study execute time:

From2022-01-12To 2022-06-01 

征募观察对象时间:

Recruiting time:

From2022-01-12To 2022-02-02 

干预措施:

Interventions:

组别:

观察组

样本量:

25

Group:

control group

Sample size:

干预措施:

常规俯卧位治疗

干预措施代码:

Intervention:

routine prone positioning

Intervention code:

组别:

干预组

样本量:

21

Group:

intervention group

Sample size:

干预措施:

俯卧位+护理运动干预

干预措施代码:

Intervention:

prone positioning+nursing exercise intervention

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

陕西 

市(区县):

西安 

Country:

China 

Province:

Shanxi 

City:

Xian 

单位(医院):

西安交通大学第一附属医院长安区医院 

单位级别:

二级甲等 

Institution
hospital:

Chang'an District Hospital of The First Affiliated Hospital of Xi'an Jiaotong University  

Level of the institution:

Grade-II hospital 

测量指标:

Outcomes:

指标中文名:

转入ICU率

指标类型:

主要指标 

Outcome:

rate of admission to ICU

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

气管插管率

指标类型:

主要指标 

Outcome:

Rate of tracheal intubation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

供氧情况变化

指标类型:

主要指标 

Outcome:

change in supplemental oxygen delivery

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胸部CT

指标类型:

主要指标 

Outcome:

chest CT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血气分析

指标类型:

次要指标 

Outcome:

Blood gas analysis

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

mMRC

指标类型:

次要指标 

Outcome:

mMRC

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Borg

指标类型:

次要指标 

Outcome:

Borg

Type:

Secondary 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 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):

由1名研究人员使用随机数字表法产生随机序列,奇数进入对照组,偶数进入观察组。

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

A researcher used a random number table method to generate a random sequence, with odd numbers entering the control group and even numbers entering the observation group.

盲法:

Blinding:

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):

不公开

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

Private

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:

病例登记表和电子病历管理系统

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

CRF and EDC system

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2022-01-15
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