Today is 2020-07-15

Muscle ultrasonography and frailty in cardiac surgery
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注册号:

Registration number:

ChiCTR2000031098 

最近更新日期:

Date of Last Refreshed on:

2020-03-22 

注册时间:

Date of Registration:

2020-03-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

Muscle ultrasonography and frailty in cardiac surgery 

Public title:

Muscle ultrasonography and frailty in cardiac surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Correlation between muscle ultrasonographic assessment of rectus femoris and Clinical Frailty Scale in elective cardiac surgical patients 

Scientific title:

Correlation between muscle ultrasonographic assessment of rectus femoris and Clinical Frailty Scale in elective cardiac surgical 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:

King Wai YAU 

研究负责人:

King Wai YAU 

Applicant:

King Wai YAU 

Study leader:

King Wai YAU 

申请注册联系人电话:

Applicant telephone:

+852 35051912 

研究负责人电话:

Study leader's telephone:

+852 35051912 

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:

derekyaukw@link.cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

derekyaukw@link.cuhk.edu.hk 

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:

Office 34, Department of Anaesthesia and Intensive Care, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Sha Tin, N.T., Hong Kong 

研究负责人通讯地址:

Office 34, Department of Anaesthesia and Intensive Care, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Sha Tin, N.T., Hong Kong 

Applicant address:

Office 34, Department of Anaesthesia and Intensive Care, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Sha Tin, N.T., Hong Kong 

Study leader's address:

Office 34, Department of Anaesthesia and Intensive Care, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Sha Tin, N.T., Hong Kong 

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:

香港中文大學麻醉與重症監護部 

Applicant's institution:

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong 

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:

2019-711 

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:

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會 

Name of the ethic committee:

The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (The Joint CUHK-NTEC CREC) 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-06 

伦理委员会联系人:

Envy Lee 

Contact Name of the ethic committee:

Envy Lee 

伦理委员会联系地址:

中國香港特別行政區新界沙田威爾士親王醫院呂志和臨床科學大樓8樓 

Contact Address of the ethic committee:

Joint CUHK-NTEC Clinical Research Ethics Committee, 8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Sha Tin, Hong Kong 

伦理委员会联系人电话:

Contact phone of the ethic committee:

35053935 

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:

N/A 

Primary sponsor:

N/A 

研究实施负责(组长)单位地址:

N/A 

Primary sponsor's address:

N/A 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

Internal funding of the department 

Source(s) of funding:

Internal funding of the department 

研究疾病:

Cardiovascular disease 

Target disease:

Cardiovascular disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

诊断试验新技术临床试验 

Study phase:

Diagnostic New Technique Clincal Study 

研究目的:

The secondary objectives of this study are to: 1. Determine the association between preoperative muscle ultrasonographic assessment on MT, CSA and echogenicity of RF, and physical performance and activity level. 2. Determine the association between preoperative muscle ultrasonographic assessment on MT, CSA and echogenicity of RF, and postoperative outcomes up to 30 days after surgery. 

Objectives of Study:

The primary objective of this study is to evaluate the relationship of muscle thickness (MT), cross-sectional area (CSA) and echogenicity of RF by muscle ultrasonographic assessment with frailty status before cardiac surgery. The secondary objectives of this study are to: 1. Determine the association between preoperative muscle ultrasonographic assessment on MT, CSA and echogenicity of RF, and physical performance and activity level. 2. Determine the association between preoperative muscle ultrasonographic assessment on MT, CSA and echogenicity of RF, and postoperative outcomes up to 30 days after surgery. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

All adult patients scheduled for elective cardiac surgery admitted to the cardiothoracic surgical ward a day before surgery will be asked to participate in the cohort study. They will be enrolled if written informed consent is made. We will recruit 85 consecutive patients undergoing major elective cardiac surgery, including coronary artery bypass graft, valve surgery or aortic intervention. 

Inclusion criteria

All adult patients scheduled for elective cardiac surgery admitted to the cardiothoracic surgical ward a day before surgery will be asked to participate in the cohort study. They will be enrolled if written informed consent is made. We will recruit 85 consecutive patients undergoing major elective cardiac surgery, including coronary artery bypass graft, valve surgery or aortic intervention. 

排除标准:

We will exclude patients undergoing emergency cardiac surgery, or patients with known musculoskeletal or neurological disorders that are associated with lower limb muscle atrophy (e.g. poliomyelitis, stroke, peripheral neuropathy); previous major surgery at lower extremity (e.g. hip replacement, metal implants at femur); or conditions that influence or are unsuitable for muscle ultrasonographic assessment, such as localised infection, skin disorders or compromised skin integrity, severe edema over thigh, and cognitive impairment (inability to provide consent). 

Exclusion criteria:

We will exclude patients undergoing emergency cardiac surgery, or patients with known musculoskeletal or neurological disorders that are associated with lower limb muscle atrophy (e.g. poliomyelitis, stroke, peripheral neuropathy); previous major surgery at lower extremity (e.g. hip replacement, metal implants at femur); or conditions that influence or are unsuitable for muscle ultrasonographic assessment, such as localised infection, skin disorders or compromised skin integrity, severe edema over thigh, and cognitive impairment (inability to provide consent). 

研究实施时间:

Study execute time:

From2020-04-01To 2020-03-31 

干预措施:

Interventions:

组别:

Case series

样本量:

85

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國 

省(直辖市):

香港特別行政區 

市(区县):

 

Country:

China 

Province:

Hong Kong SAR 

City:

 

单位(医院):

威爾士親王醫院 

单位级别:

三级 

Institution
hospital:

Prince of Wales Hospital  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

指标中文名:

Clinical Frailty Scale, postoperative mortality, major adverse cardiocerebral events, number of days (alive and) at home within 30 days of surgery (DAH30).

指标类型:

主要指标 

Outcome:

Clinical Frailty Scale, postoperative mortality, major adverse cardiocerebral events, number of days (alive and) at home within 30 days of surgery (DAH30).

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:

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):

N/A

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

N/A

盲法:

N/A

Blinding:

N/A

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):

Only group data will be published.

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

Only group data will be published.

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:

Data will be kept confidential in secure offices of the Department of Anaesthesia and Intensive Care. Hardcopy data will be destroyed 5 years after last publication of results. Electronic data password protected will be kept in project coordinator, research nurse and PI's office computers that are also password protected.

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

Data will be kept confidential in secure offices of the Department of Anaesthesia and Intensive Care. Hardcopy data will be destroyed 5 years after last publication of results. Electronic data password protected will be kept in project coordinator, research nurse and PI's office computers that are also password protected.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-03-22
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