ChiCTR2100053598 版本V1.1 版本创建时间2022/05/21 16:16:45 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2100053598 

最近更新日期：

Date of Last Refreshed on：

 2021-11-24 23:11:17 

注册时间：

Date of Registration：

 2021-11-24 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

该研究尚未获得伦理委员会批准，请于批准后再开始纳入参试者，并与我们联系上传批件。 食管癌根治术中分阶段目标导向液体治疗对术后血管外肺水的影响

Public title：

Effect of goal directed guided fluid therapy on postoperative extravascular lung water in radical esophagectomy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

食管癌根治术中分阶段目标导向液体治疗对术后血管外肺水的影响

Scientific title：

Effect of goal directed guided fluid therapy on postoperative extravascular lung water in radical esophagectomy

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：

杨超 

研究负责人：

谢言虎 

Applicant：

Chao Yang 

Study leader：

Yanhu Xie 

申请注册联系人电话：

Applicant telephone：

 13955415324

研究负责人电话：

Study leader's
telephone：

133956013081

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：

 851373813@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 xyh200701@sina.cn

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：

安徽省合肥市政务区天鹅湖路1号

研究负责人通讯地址：

安徽省合肥市政务区天鹅湖路1号

Applicant address：

No.1 Swan Hu Road, Hefei government district, Hefei, Anhui Province, China

Study leader's address：

No.1 Swan Hu Road, Hefei government district, 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：

中国科学技术大学附属第一医院南区（安徽省立医院南区）

Applicant's institution：

South District, the First Affiliated Hospital of USTC(nandistrict, Anhui Provincial Hospita

研究负责人所在单位：

中国科学技术大学附属第一医院南区（安徽省立医院南区）

Affiliation of the Leader：

South District, the First Affiliated Hospital of USTC(nandistrict, Anhui Provincial Hospita

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 00:00:00

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：

中国科学技术大学附属第一医院南区（安徽省立医院南区）

Primary sponsor：

South District, the First Affiliated Hospital of USTC(nandistrict, Anhui Provincial Hospita

研究实施负责（组长）单位地址：

安徽省合肥市政务区天鹅湖路1号

Primary sponsor's address：

No.1 Swan Hu Road, Hefei government district, 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

市(区县)：

合肥

Country：

China

Province：

Anhui

City：

Hefei

单位(医院)：

中国科学技术大学附属第一医院南区（安徽省立医院南区）

具体地址：

政务区天鹅湖路1号

Institution
hospital：

South District of the First Affiliated Hospital of University of Science and Technology of China (South District of Anhui Provincial Hospital)

Address：

1 Tian'ehu Road, Zhengwu District

经费或物资来源：

科室科研经费

Source(s) of funding：

Scientific research funding for subjects

研究疾病：

食管癌  

Target disease：

esophageal cancer

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

探究在mckeown食管癌根治术中分阶段目标导向液体治疗与单一阶段目标导向液体治疗相比能否减少术后血管外肺水，降低术后肺部并发症发生率  

Objectives of Study：

To investigate whether staged goal-directed fluid therapy compared with single-stage goal-directed fluid therapy in McKeown esophagectomy can reduce postoperative extravascular lung water and reduce the incidence of postoperative pulmonary complications

药物成份或治疗方案详述：

①麻醉诱导：患者在手术前接了限制饮食。在麻醉诱导前，进行标准化中心静脉穿刺，并使用20-G 动脉导管插入非优势前臂的桡动脉。连续监测心率(HR)、MAP、CVP、脉搏血氧饱和度(SpO2)、呼气 末二氧化碳分压(PETCO2)、体温和双谱指数(BIS)。通过 Lidco系统测量 SVV、心脏指数(CI)、心输出量和每搏输出量。开始全身麻醉时，静脉注射0.05 mg/kg咪达唑仑、2 mg/kg丙泊酚、0.4 mg/kg舒芬太尼和1.0 mg/kg罗库溴铵。 随后，持续输注丙泊酚(4-8mg/kg/h)和瑞芬太尼(0.05- 0.2g/kg/min)维持术中麻醉，以使 BIS目标值达到 40-50.麻醉诱导后，插入左侧双腔支气管导管并经支气管镜检查证实。患者按照研究方案使用麻醉机在容量控制模式下进行通气，潮气量(VT) 8 mL/kg(双肺通气)或 6 mL/kg (OLV)，吸入氧分数(FiO2) 100%，吸气与呼气时间(I/E)比为 1:2，呼气末正压(PEEP)5 cmH2O； 调整呼吸率，使 PETCO2 维持在 35-45 mmHg 之间。当外周血氧饱和度降至 90%以下时，对非通气肺应用 1–2 cmH2O的持续气道正压(CPAP)或对通气肺应用肺复张策略。采用流体加温器或医用加温毯维持鼻咽部 温度> 36 ℃。根据要求，在手术过程中间歇给予额外的舒芬太尼或顺式阿曲库铵。 ③ 目标导向液体治疗方案 实验组：每5min测量一次血流动力学参数，单肺通气阶段，当svv>10%时，在20min内输入4ml/kg胶体，如果svv变化不明显（svv下降<2%),静推麻黄碱5-15mg。当svv在10%-7%时，若CI低于2.5，则推注麻黄碱5-15mg，若平均压低于65mmhg则泵注去甲肾4-10ug/min。当svv<7%时，减慢或停止输液。双肺通气时：液体治疗方案与单肺通气时相同，仅将目标svv更换为10%-13% 对照组：方案与实验组相同，仅将目标SVV全程维持在%7-10% 

Description for medicine or protocol of treatment in detail：

① Induction of anesthesia: the patient received a restricted diet before surgery. Before induction of anesthesia, standardized central venipuncture was performed, and a 20-G arterial catheter was used to insert the radial artery of the nondominant forearm. Heart rate (HR), map, CVP, pulse oximetry (SpO2), partial pressure of end tidal carbon dioxide (PetCO2), body temperature, and bispectral index (BIS) were continuously monitored. SVV, cardiac index (CI), cardiac output, and stroke volume were measured by the lidco system. For the initiation of general anesthesia, 0.05 mg / kg midazolam, 2 mg / kg propofol, 0.4 mg / kg sufentanil, and 1.0 mg / kg rocuronium were administered intravenously. Subsequently, intraoperative anesthesia was maintained by continuous infusion of propofol (4-8 mg / kg / h) and remifentanil (0.05 - 0.2 g / kg / min) to achieve the BIS target value of 40-50.after induction of anesthesia, a left double lumen bronchial catheter was inserted and confirmed by bronchoscopy. Patients were ventilated according to the study protocol using an anesthesia machine in volume controlled mode with tidal volume (VT) of 8 ml / kg (double lung ventilation) or 6 ml / kg (OLV), fraction of inspired oxygen (FiO2) of 100%, inspiratory to expiratory time (I / E) ratio of 1:2, and positive end expiratory pressure (PEEP) of 5 cmH2O; The respiration rate was adjusted so that PetCO2 was maintained between 35-45 mmHg. When peripheral oxygen saturation dropped below 90%, a continuous positive airway pressure (CPAP) of 1 – 2 cmH2O was applied to the nonventilated lung or a lung recruitment strategy was applied to the ventilated lung. The nasopharynx temperature is maintained > 36 ° C with a fluid warmer or medical warming blanket. Upon request, additional sufentanil or CIS atracurium was administered intermittently during the procedure. ③ Goal directed fluid therapy protocol Experimental group: hemodynamic parameters were measured every 5min during the one lung ventilation phase when the SVV was > 10% and 4 ml / kg of colloid was infused over 20min if the SVV did not change significantly (SVV drop < 2%), static bolus of ephedrine 5-15mg. When SVV is < 10% - 7%, bolus of ephedrine 5-15mg with CI below 2.5, pump norepinephrine 4-10ug / min if mean pressure is < 65mmhg. Slow down or stop infusion when SVV is < 7%. On two lung ventilation: fluid regimen is the same as on one lung ventilation, only change target SVV to 10% - 13% Control group: Protocol identical to experimental group, maintaining target SVV only at% 7-10% throughout 

纳入标准：

年龄18-75岁；美国麻醉师协会（ASA）分级Ⅰ-Ⅲ级；体质指数（BMI）18~30kg/m；诊断为食管癌拟行择期mckeown食管癌根治术的患者

Inclusion criteria

Age 18-75 years; American Society of anesthesiologists (ASA) grade I-III; Body mass index (BMI) 18-30kg / M; Patients diagnosed with esophageal cancer scheduled for elective McKeown radical esophagectomy

排除标准：

严重心律失常、心力衰竭肝肾功能不全、术前酸碱平衡紊乱及电解质紊乱、术前重度呼吸功能不全、凝血功能异常

Exclusion criteria：

Severe arrhythmia, heart failure liver and kidney dysfunction, preoperative disturbance of acid-base balance and electrolyte imbalance, preoperative severe respiratory insufficiency, and abnormal coagulation

研究实施时间：

Study execute time：

从 From 2022-12-15 00:00:00至 To 2023-12-15 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-12-15 00:00:00 至 To 2023-12-15 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 40

Group：

Experimental group

Sample size：

干预措施：

分阶段目标导向液体疗法

干预措施代码：

Intervention：

Staged goal directed fluid therapy

Intervention code：

组别：

对照组

样本量：

 40

Group：

Control group

Sample size：

干预措施：

单阶段目标导向液体疗法

干预措施代码：

Intervention：

Single stage goal directed fluid therapy

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)：

 合肥 

Country：

China

Province：

Anhui

City：

Hefei

单位(医院)：

 中国科学技术大学附属第一医院南区（安徽省立医院南区） 

单位级别：

 三甲 

Institution
hospital：

South District of the First Affiliated Hospital of University of Science and Technology of China (South District of Anhui Provincial Hospital)

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

内皮糖萼降解产物

指标类型：

主要指标

Outcome：

Endothelial glycocalyx degradation products

Type：

Primary indicator

测量时间点：

手术开始前，手术结束时，术后1天

测量方法：

Measure time point of outcome：

before surgery, at the end of surgery, and 1 day after surgery

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

外周静脉

Sample Name：

blood

Tissue：

Peripheral venous

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 岁 years
最大 Max age 75 岁 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）：

所有纳入的患者按 1:1 的比例分配到实验组和对照组。采用基于计算机随机数发生器的顺序分组法分层随机分配。

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

All included patients were allocated in a 1:1 ratio to experimental and control groups. Random assignment was stratified by sequential block method based on a computer random number generator.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

为确保数据采集的可靠性，患者、负责采集数据和血样的临床研究人员以及术后随访团队对患者分组均不知情。

Blinding：

To ensure reliability of data acquisition, patients, clinical investigators responsible for collecting data and blood samples, and the postoperative follow-up team were blinded to patient grouping.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

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）：

http://www.chictr.org.cn/assproject2.aspx

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

http://www.chictr.org.cn/assproject2.aspx

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：

病例报告表由实验发起者与实验负责人一起设计。所有患者电子身份信息将在一个安全的数据库上进行，只能由基本人员访问。具有患者识别信息的文件将在安徽省立医院南区限制区的安全锁定文件柜中，患者只能由代码号识别。直接访问源数据/文件需要通过监控。所有纸张和电子数据将在试验结束后至少保留5年

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

The case report form was designed by the experimental sponsor in conjunction with the experimental lead. All patient electronic identifying information will be performed on a secure database, accessible only by basic personnel. Files with patient identification information will be in a secured locked file cabinet in the restricted area of the Southern District of Anhui Provincial Hospital, and patients can only be identified by the code number. Direct access to source data / files needs to be monitored. All paper and electronic data will be retained for at least 5 years after the end of the trial

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-11-24 23:11:13