经皮穴位电刺激对胸腔镜肺叶切除术围术期肺功能短期疗效评价

注册号:

Registration number:

ITMCTR2025001331

最近更新日期:

Date of Last Refreshed on:

2025-07-03

注册时间:

Date of Registration:

2025-07-03

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

经皮穴位电刺激对胸腔镜肺叶切除术围术期肺功能短期疗效评价

Public title:

Transcutaneous auricular electrical acupoint stimulation for short-term efficacy evaluation of pulmonary function in perioperative period of thoracoscopic lobect

注册题目简写:

English Acronym:

研究课题的正式科学名称:

经皮穴位电刺激对胸腔镜肺叶切除术围术期肺功能短期疗效评价方案

Scientific title:

Scheme for the short-term efficacy evaluation of transcutaneous acupoint electrical stimulation on pulmonary function in the perioperative period of thoracoscopicectomy for lung cancer

研究课题的正式科学名称简写:

Scientific title acronym:

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:

唐晨晓

研究负责人:

唐晨晓

Applicant:

Chenxiao Tang

Study leader:

Chenxiao Tang

申请注册联系人电话:

Applicant telephone:

18768877843

研究负责人电话:

Study leader's telephone:

18768877843

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:

75748504@qq.com

研究负责人电子邮件:

Study leader's E-mail:

75748504@qq.com

申请单位网址(自愿提供):

Study leader's 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:

河南省郑州市河南省直第三人民医院

研究负责人通讯地址:

河南省郑州市河南省直第三人民医院

Applicant address:

Henan Provincial Third People's Hospital in Zhengzhou City Henan Province

Study leader's address:

Henan Provincial Third People's Hospital in Zhengzhou City Henan Province

申请注册联系人邮政编码:

Applicant postcode:

451100

研究负责人邮政编码:

Study leader's postcode:

451100

申请人所在单位:

河南省直第三人民医院

Applicant's institution:

Henan Provincial Third People's Hospital

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2025SZSYLCYJ0304

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

河南省直第三人民医院伦理委员会

Name of the ethic committee:

The Ethics Committee of the Third People's Hospital of Henan Province

伦理委员会批准日期:

Date of approved by ethic committee:

2025/3/26 0:00:00

伦理委员会联系人:

李晶

Contact Name of the ethic committee:

Jing Li

伦理委员会联系地址:

河南省郑州市郑东新区河南省直第三人民医院

Contact Address of the ethic committee:

Henan Provincial Third People's Hospital Zhengdong New District Zhengzhou City Henan Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

0371-85967919

伦理委员会联系人邮箱:

Contact email of the ethic committee:

szsyywk@sina.com

研究实施负责(组长)单位:

河南省直第三人民医院

Primary sponsor:

Henan Provincial Third People's Hospital

研究实施负责(组长)单位地址:

河南省郑州市郑东新区河南省直第三人民医院

Primary sponsor's address:

Henan Provincial Third People's Hospital Zhengdong New District Zhengzhou City Henan Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

河南省

市(区县):

Country:

China

Province:

Henan Province

City:

单位(医院):

河南省直第三人民医院

具体地址:

河南省郑州市郑东新区河南省直第三人民医院

Institution
hospital:

Henan Provincial Third People's Hospital

Address:

Henan Provincial Third People's Hospital Zhengdong New District Zhengzhou City Henan Province

经费或物资来源:

国家自然科学基金资助,项目名称为“转录因子C/EBP β介导的抑制性突触重构在慢性术后疼痛中的作用及机制研究”,资助金额为人民币55万元

Source(s) of funding:

Supported by the National Natural Science Foundation of China the project is titled "Study on the Role and Mechanism of Transcriptional Factor C/EBP β Mediated Inhibitory Synaptic Reconstruction in Chronic Postoperative Pain" with a funding amount of RMB 550000

研究疾病:

肺叶切除术围术期肺功能

研究疾病代码:

Target disease:

Perioperative pulmonary function of lobectomy

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

其它

Others

研究目的:

本研究的主要目的是评估经皮穴位电刺激(TEAS)对胸腔镜肺叶切除术患者围术期肺功能的短期改善效果,验证TEAS在围术期肺功能保护中的临床价值。

Objectives of Study:

The primary purpose of this study was to evaluate the short-term improvement effect of transcutaneous auricular electrical stimulation (TEAS) on pulmonary function patients undergoing video-assisted thoracoscopic lobectomy and to verify the clinical value of TEAS in the protection of pulmonary function perioperatively

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

①确诊为需要接受胸腔镜肺叶切除术的患者,包括但不限于肺癌、支气管扩张症、肺良性肿瘤等;②年龄18-75岁;③手术方式:接受胸腔镜肺叶切除术;④语言能力:患者能够理解并配合研究人员的指导;⑤肺功能评估:术前肺功能检查显示患者具有一定的肺功能储备(如FEV1 > 1.0 L或预计值的40%以上)。

Inclusion criteria

①Patients who have been diagnosed with diseases that are suitable for video-assisted thoracoscopic lobectomy including but not limited to lung cancerchiectasis benign lung tumors etc.;②Aged 18-75 years old;③Surgical method: received video-assisted thoracoscopicectomy;④Language ability: patients were able to understand and cooperate with the instructions of the researchers;⑤Lung function assessment: preoperative pulmonary function tests showed that the had a certain lung function reserve (such as FEV1 > 1.0 L or more than 40% of the predicted value).

排除标准:

①严重心肺功能不全:如重度心力衰竭、严重慢性阻塞性肺疾病(COPD)等②凝血功能障碍:如血友病、严重血小板减少症等;③精神疾病或认知障碍:如严重抑郁症、精神分裂症、痴呆等;④对电刺激治疗过敏或禁忌:如安装心脏起搏器、植入式除颤器等。⑤正在接受其他临床试验:患者正在参与其他临床试验,可能导致结果混淆;⑥无法配合治疗或随访:患者无法或不愿意配合治疗方案或随访计划。

Exclusion criteria:

① Severe cardiopulmonary insufficiency: such as severe heart failure severe chronic obstructive pulmonary disease (COPD) etc;② Coagulation dysfunction: such as hemophilia severe thrombocytopenia etc.;③ Mental illness or cognitive impairment: such as severe depression schizophrenia dementia etc.;④ Allergy or contraindication to electrostimulation therapy: such as patients with cardiac pacemakers implantable defibrillators etc;⑤ Participating in other clinical trials: patients who are participating in other clinical trials may lead to confounding results;⑥ Unable to cooperate with treatment or follow-up: patients are unable or unwilling to cooperate with the treatment plan or follow-up plan.

研究实施时间:

Study execute time:

From 2025-08-01

To      2026-07-31

征募观察对象时间:

Recruiting time:

From 2025-09-01

To      2026-04-30

干预措施:

Interventions:

组别:

Control组

样本量:

40

Group:

Control Group

Sample size:

干预措施:

在相同穴位粘贴电极片但不行电流刺激

干预措施代码:

Intervention:

Paste electric grade films on the same acupoints without current stimulation

Intervention code:

组别:

TEAS组

样本量:

40

Group:

TEAS Group

Sample size:

干预措施:

在特定穴位行电刺激

干预措施代码:

Intervention:

Electrical stimulation at specific acupoints

Intervention code:

样本总量 Total sample size : 80

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

河南

市(区县):

Country:

China

Province:

Henan

City:

单位(医院):

河南省直第三人民医院

单位级别:

三级综合医院

Institution/hospital:

Henan Provincial Third People's Hospital

Level of the institution:

Third level comprehensive hospital

测量指标:

Outcomes:

指标中文名:

超氧化物歧化酶

指标类型:

次要指标

Outcome:

Superoxide Dismutase

Type:

Secondary indicator

测量时间点:

单肺通气前、单肺通气后30min、单肺通气后1h、恢复双肺通气后10min

测量方法:

在测量时间点采集患者外周静脉血,送医院检验科检验相关指标数值

Measure time point of outcome:

Before unilateral ventilation; 30 minutes after unilateral ventilation; 1 hour after unilateral ventilation; 10 minutes after the return of bilateral ventilation

Measure method:

Peripheral venous blood was collected from the patients at the time of measurement and sent to the laboratory of the hospital for examination of relevant index values

指标中文名:

深吸气量(IC)

指标类型:

主要指标

Outcome:

Inspiratory Capacity(IC)

Type:

Primary indicator

测量时间点:

术前1天、术后24小时、术后72小时

测量方法:

使用肺功能仪行肺功能测量

Measure time point of outcome:

Preoperative 1 day; postoperative 24 hours; postoperative 72 hours

Measure method:

Pulmonary function test by spirometry

指标中文名:

Borg呼吸困难评分量表评分

指标类型:

次要指标

Outcome:

Borg Dyspnea Rating Scale scoring

Type:

Secondary indicator

测量时间点:

术前1天、术后3天

测量方法:

患者自行填写Borg呼吸困难评分量表

Measure time point of outcome:

Preoperative 1 day postoperative 3 days

Measure method:

The patients filled in the Borg dyspnea rating scale by themselves

指标中文名:

第一秒用力呼气容积(FEV1)

指标类型:

主要指标

Outcome:

First Expiratory Volume in One Second(FEV1)

Type:

Primary indicator

测量时间点:

术前1天、术后24小时、术后72小时

测量方法:

使用肺功能仪行肺功能测量

Measure time point of outcome:

Preoperative 1 day; postoperative 24 hours; postoperative 72 hours

Measure method:

Pulmonary function test by spirometry

指标中文名:

用力肺活量(FVC)

指标类型:

主要指标

Outcome:

Forced Vital Capacity(FVC)

Type:

Primary indicator

测量时间点:

术前1天、术后24小时、术后72小时

测量方法:

使用肺功能仪行肺功能测量

Measure time point of outcome:

Preoperative 1 day; postoperative 24 hours; postoperative 72 hours

Measure method:

Pulmonary function test by spirometry

指标中文名:

丙二醛

指标类型:

次要指标

Outcome:

Malondialdehyde

Type:

Secondary indicator

测量时间点:

单肺通气前、单肺通气后30min、单肺通气后1h、恢复双肺通气后10min

测量方法:

在测量时间点采集患者外周静脉血,送医院检验科检验相关指标数值

Measure time point of outcome:

Before unilateral ventilation; 30 minutes after unilateral ventilation; 1 hour after unilateral ventilation; 10 minutes after the return of bilateral ventilation

Measure method:

Peripheral venous blood was collected from the patients at the time of measurement and sent to the laboratory of the hospital for examination of relevant index values

指标中文名:

膈肌活动度

指标类型:

次要指标

Outcome:

Diaphragmatic mobility

Type:

Secondary indicator

测量时间点:

术前1天、术后3天

测量方法:

使用超声测量膈肌活动度

Measure time point of outcome:

Preoperative 1 day postoperative 3 days

Measure method:

Use ultrasound to measure diaphragm activity

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:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 65
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

确保医生和患者不能事先知道或决定患者将分配到哪一组接受治疗,且不能从一个患者已经进入的组别推测出下一个患者将分配到哪一组。 具体方法 产生人员:由不参与患者招募、治疗和评估的独立统计学家或数据管理员负责产生随机序列。 产生方法:采用计算机随机数字生成器产生随机序列。 分组实施:将产生的随机序列分配给合格的患者,使用按顺序编码、不透光、密封的信封进行随机分配方案的隐匿。信封在患者同意进入试验并由研究人员确认符合纳入标准后打开,以确保分配的盲态。

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

Ensure that doctors and patients do not know or decide in advance which group a patient will be assigned to receive treatment and cannot infer which group the next patient will be assigned to from the group that a patient has already entered. Specific methods Generation personnel: Independent statisticians or data administrators who are not involved in patient recruitment treatment and evaluation are responsible for generating random sequences. Method of generation: Use a computer random number generator to generate a random sequence. Grouping implementation: The generated random sequence is assigned to qualified patients and the random allocation scheme is concealed using sequentially encoded opaque and sealed envelopes. The envelope is opened after the patient agrees to enter the trial and the researchers confirm compliance with the inclusion criteria to ensure allocation of blinding.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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):

向研究者索取 预计在临床试验完成后6个月内公开数据,具体日期为:2026年12月31日。邮箱075748504@163.com

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

Request data from the researcher, which is expected to be made public within 6 months after the completion of the clinical trial, with a specific date of: December 1, 2026. Email 075748504@163.com

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:

以病例记录表(CRF)和(或)EDC系统记录病人接受干预后的临床信息

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

Collecting the clinical information by Case Record Form (CRF) and (or) EDC system

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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