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强化保温和常规保温管理对中老年食管癌根治术患者心肌损伤的影响:随机对照试验
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注册号:

Registration number:

ChiCTR-INR-17011621 

最近更新日期:

Date of Last Refreshed on:

2017-09-26 

注册时间:

Date of Registration:

2017-06-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

强化保温和常规保温管理对中老年食管癌根治术患者心肌损伤的影响:随机对照试验 

Public title:

Aggressive vs. standard body temperature management on myocardial injury in mid-aged and elderly patients receiving curative resection of esophageal carcinoma: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

强化保温和常规保温管理对中老年食管癌根治术患者心肌损伤的影响:随机对照试验 

Scientific title:

Aggressive vs. standard body temperature management on myocardial injury in mid-aged and elderly patients receiving curative resection of esophageal carcinoma: a randomized controlled trial 

研究课题代号(代码):

Study subject ID:

上海市科学技术委员会项目(16411967600) 

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:

吴镜湘 

研究负责人:

吴镜湘 

Applicant:

Jingxiang Wu 

Study leader:

Jingxiang Wu 

申请注册联系人电话:

Applicant telephone:

+86 13641629197 

研究负责人电话:

Study leader's telephone:

+86 13641629197 

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:

wjx1132@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wjx1132@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:

上海市淮海西路241号,胸科医院麻醉科 

研究负责人通讯地址:

上海市淮海西路241号,胸科医院麻醉科 

Applicant address:

Anesthesiology department of Shanghai Chest Hospital, 241 Huaihai Road West, Shanghai, China 

Study leader's address:

Anesthesiology department of Shanghai Chest Hospital, 241 Huaihai Road West, Shanghai, China  

申请注册联系人邮政编码:

Applicant postcode:

200030 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

上海交通大学附属胸科医院 

Applicant's institution:

Shanghai Chest Hospital, Shanghai Jiao Tong 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:

KS1614 

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:

上海市胸科医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Shanghai Chest Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

2016-05-06 

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:

上海交通大学附属胸科医院 

Primary sponsor:

Shanghai Chest Hospital, Shanghai Jiao Tong University 

研究实施负责(组长)单位地址:

上海市淮海西路241 

Primary sponsor's address:

Anesthesiology department of Shanghai Chest Hospital, 241 Huaihai Road West, Shanghai, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

上海市科学技术委员会项目(16411967600) 

Source(s) of funding:

Shanghai science and technology committee (16411967600) 

研究疾病:

食管癌 

Target disease:

esophageal carcinoma 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

强化保温管理(相对于常规保温管理)是否可以降低中老年食管癌根治术患者心肌损伤的的发生 

Objectives of Study:

To examine whether aggressive body temperature management(relative to standard management)could attenuate myocardial injury in mid-aged and elderly patients receiving curative resection of esophageal carcinoma 

药物成份或治疗方案详述:

1患者按1:1比例随机分为常规体温管理组和强化保温组,术中持续监测中心体温(诱导前监测耳膜温,诱导后监测鼻咽温)。术中加温采用两档加温毯:43℃和46℃(加热十分钟自动切换43℃),加温毯覆盖在患者骨盆及双下肢。 2 常规管理组,入室不开启加温毯。当患者体温≤35℃时,开启加温毯,若中心体温连续低于35.0℃超过20min,则需要颈肩部加温毯加温;当患者体温回升至35.2℃时,停止使用加温毯。 3 强化体温管理组,入室即开启加温毯。当患者体温升高至37℃时停止使用加温毯,当患者体温下滑至36.5℃再次开启加温毯;当患者体温下降至36℃以下时需要颈肩部加温毯加温。 

Description for medicine or protocol of treatment in detail:

1 Subjects will be randomized at a 1:1 ratio to receive standard vs. aggressive body temperature management based on core temperature (monitored continuously, using a probe inserted to the pharynx after anesthesia induction, and using a probe inserted to the ear drum prior to anesthesia induction) during the surgery. Heating is provided by a heating pad with 2 setting: 43.0℃ (low) and 46.0 ℃ (high; with a maximum duration of 10 min). The heating pad covers the lower extremities and the pelvic region. 2 In the standard management arm, the heating pad is off upon patient arrival. The pad is turned on if body temperature drops to 35.0℃. An additional heating pad is used in the neck and shoulder areas if body temperature remains at <35.0℃ for 20 min. The heating pad is turned off when body temperature rises to 35.2℃ 3 In the aggressive management arm, the heating pad is turned on upon patient arrival. The pad is turned off when body temperature increases to 37.0℃ and turned on when body temperature decreases to 36.5℃; an additional heating pad is used in the neck and shoulder areas if body temperature drops to 36.0℃.  

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1 ASAI 或II级行食管癌根治术的全麻患者 2 年龄:45-80岁 3 手术时间2-6小时 

Inclusion criteria

1. ASA I or II patients scheduled to receive curative resection of esophageal carcinoma under general anesthesia; 2. age 45-80 years; 3. duration of the surgery expected to last 2-6 hours. 

排除标准:

1 严重心血管疾病的患者 2 血清肌钙蛋白I>0.03ng/ml 3 体质指数>30kg/m2 4 需要透析的晚期肾病 5 感染、脓毒血症 6 凝血障碍 

Exclusion criteria:

Exclusion criteria: 1. Patients with major cardiovascular diseases at the baseline; 2. Preoperative serum troponin I at >0.03 ng/ml; 3. BMI>30kg/m2; 4. End-stage renal diseases requiring dialysis; 5. Major infection (including but not limited to septicemia); 6. clinically important coagulopathy. 

研究实施时间:

Study execute time:

From2017-06-20To 2018-06-20 

干预措施:

Interventions:

组别:

常规体温管理组

样本量:

35

Group:

Standard body temperature management

Sample size:

干预措施:

常规体温管理(当核心体温≤35.0℃时开始加温,当温度回升至35.2℃时停止加温)

干预措施代码:

Intervention:

Standard body temperature management (heating when core body temperature drops below ≤35.0 degree; discontinuing heating when body temperature rises to 35.2 degree)

Intervention code:

组别:

强化保温组

样本量:

35

Group:

Aggressive body temperature management

Sample size:

干预措施:

强化体温管理(当中心体温≤36.5℃采取保温,当中心温度升高至37℃时停止保温)

干预措施代码:

Intervention:

Aggressive body temperature management (heating when core body temperature drops below ≤36.5 degree; discontinuing heating when body temperature rises to 37.0 degree)

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):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学附属胸科医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Chest Hospital, Shanghai Jiao Tong University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

肌钙蛋白I

指标类型:

主要指标 

Outcome:

Troponin I

Type:

Primary indicator 

测量时间点:

术前、术后6-12h、24h、48h

测量方法:

血清

Measure time point of outcome:

preoperative, postoperative 6-12h, 24h, 48h

Measure method:

serum

指标中文名:

肌钙蛋白T

指标类型:

次要指标 

Outcome:

TroponinT

Type:

Secondary indicator 

测量时间点:

术前、术后6-12h、24h、48h

测量方法:

血清

Measure time point of outcome:

preoperative, postoperative 6-12h, 24h, 48h

Measure method:

serum

指标中文名:

严重心律失常,包括房颤、室上性心动过速、频发室早

指标类型:

次要指标 

Outcome:

severe arrhythmia,including atrial fibrillation,supraventricular tachycardia,frequent premature ventricular contration

Type:

Secondary indicator 

测量时间点:

术中及术后住院期间

测量方法:

术中观察及医师随访

Measure time point of outcome:

intraoperative and postoperative hospital stay

Measure method:

指标中文名:

住院期间其他不良事件,包括低氧血症、电解质紊乱、深静脉血栓/肺栓塞

指标类型:

次要指标 

Outcome:

Other major adverse events prior to patient discharge from hospital, including postoperative hypoxemia, electrolyte disturbances ,deep vein thrombosis/pulmonary embolism

Type:

Secondary indicator 

测量时间点:

术后住院期间

测量方法:

医师随访

Measure time point of outcome:

postoperative hospital stay

Measure method:

指标中文名:

ICU停留时间和术后住院时间

指标类型:

次要指标 

Outcome:

ICU and hospital stay

Type:

Secondary indicator 

测量时间点:

术后住院期间

测量方法:

医师随访

Measure time point of outcome:

postoperative hospital stay

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 45 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):

患者按1:1比例随机入组。随机序列由不参与本研究的工作人员用计算机生成。隐藏使用不透光信封法。

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

Subjects will be randomized at a 1:1 ratio using simple randomization. The randomization sequence will be generated by a staff not otherwise involved in the current study. Concealment will be conducted using sealed opaque envelopes.

盲法:

Blinding:

Participants are blinded to group assignment. Anesthesiologist will be aware of the group assignment in each case. The research scientist who analyzes the data will be blinded.

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:

试验完成后6个月内公开/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):

2018年12月 Resman 临床试验管理平台

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

December 2018 Resman http://www.medresman.org/

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:

Word,Excel,SPSS 以及上海市胸科医院电子病例

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

Word, Excel, SPSS and electric record of Shanghai Chest Hospital

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2017-06-10
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