ChiCTR2400087561 版本V1.0 版本创建时间2024/07/30 15:24:49 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：

 ChiCTR2400087561 

最近更新日期：

Date of Last Refreshed on：

 2024-07-30 15:24:32 

注册时间：

Date of Registration：

 2024-07-30 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

不同中医体质老年全麻手术患者术中低体温发生特点及复温效果研究

Public title：

Research on the Characteristics of Intraoperative Hypothermia and Re-Warming Effects in Elderly Patients Under General Anesthesia with Different Traditional Chinese Medicine Constitutions.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

不同体质类型的全麻患者术后低温预警系统构建以及充气加温毯的干预

Scientific title：

Construction of a postoperative hypothermia early warning system for patients under general anesthesia with different body types and intervention with inflatable warming blankets

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：

韩书军 

研究负责人：

韩书军 

Applicant：

Shujun Han 

Study leader：

Shujun Han 

申请注册联系人电话：

Applicant telephone：

 +86 186 7594 7300

研究负责人电话：

Study leader's
telephone：

+86 186 7594 7300

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：

 18675947300@163.com

研究负责人电子邮件：

Study leader's E-mail：

 18675947300@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：

广东省广州市白云区机场路16号

研究负责人通讯地址：

广东省广州市白云区机场路16号

Applicant address：

No.16, Airport Road, Baiyun District, GuangZhou, GuangDong

Study leader's address：

No.16, Airport Road, Baiyun District, GuangZhou, GuangDong

申请注册联系人邮政编码：

Applicant postcode：

 510405

研究负责人邮政编码：

Study leader's postcode：

 510405

申请人所在单位：

广州中医药大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

研究负责人所在单位：

广州中医药大学第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

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：

 K-2022-010

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：

广州中医药大学第一附属医院伦理委员会

Name of the ethic committee：

The ethic committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-03-07 00:00:00

伦理委员会联系人：

黎欣盈

Contact Name of the ethic committee：

Xinying Li

伦理委员会联系地址：

广东省广州市白云区机场路16号

Contact Address of the ethic committee：

No.16, Airport Road, Baiyun District, GuangZhou, GuangDong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 3658 8667

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：

广州中医药大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

研究实施负责（组长）单位地址：

广东省广州市白云区机场路16号

Primary sponsor's address：

No.16, Airport Road, Baiyun District, GuangZhou, GuangDong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东省

市(区县)：

广州市

Country：

China

Province：

Guangdong province

City：

Guangzhou city

单位(医院)：

广州中医药大学第一附属医院

具体地址：

广东省广州市白云区机场路16号

Institution
hospital：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Address：

No.16, Airport Road, Baiyun District, GuangZhou, GuangDong

经费或物资来源：

广东省中医药局科研项目

Source(s) of funding：

Scientific Research Program of the Guangdong Provincial Bureau of Traditional Chinese Medicine

研究疾病：

术中低体温  

Target disease：

intraoperative hypothermia

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：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1. 对不同中医体质类型的全麻患者术后低体温发生的危险因素进行整理和分析，并初步构建预警评分系统，为识别低体温高危患者并进行早期干预提供参考。 2. 通过效果观察评价该预警评分系统的诊断价值和充气加温毯的防治干预有效性，以降低全麻患者术后低体温的发生率，完善中医院术后低体温管理规范与流程。  

Objectives of Study：

1. The risk factors for postoperative hypothermia in patients with different Traditional Chinese Medicine (TCM) constitution types under general anesthesia were organized and analyzed, and a preliminary warning scoring system was established to provide a reference for identifying high-risk patients for hypothermia and for early intervention. 2. Evaluate the diagnostic value of the warning scoring system and the effectiveness of the heated blanket intervention through effect observation, in order to reduce the incidence of postoperative hypothermia in patients under general anesthesia and to improve the management standards and processes for postoperative hypothermia in traditional Chinese medicine hospitals.

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) 构建全麻术后低体温风险预测模型 纳入标准：1. 符合美国麻醉医师协会(ASA)“术前病情评估标准”1 至 3 级的患者；2. 年龄≥18 周岁；3. 择期手术；4. 手术均在全身麻醉方式下进行者；5. 术前核心体温≥36℃。 (2) 全麻术后低体温患者充气加温毯干预 纳入标准：自愿参加本研究，并签署知情同意书；行非心脏手术的全身麻醉患者且入麻醉恢复室即刻耳温低于 36℃者。

Inclusion criteria

(1) Constructing a risk prediction model for hypothermia after general anesthesia. Inclusion criteria:1. Patients who meet the American Society of Anesthesiologists (ASA) "Preoperative Physical Status Classification" levels 1 to 3; 2. Age ≥18 years old; 3. Elective surgery; 4. Surgery performed under general anesthesia; 5. Preoperative core body temperature ≥36°C. (2) Intervention of heated air-filled blankets for patients with hypothermia after general anesthesia. Inclusion criteria: Voluntarily participate in this study and sign the informed consent form; patients undergoing non-cardiac surgery who are under general anesthesia and have an immediate ear temperature below 36℃ upon entering the anesthesia recovery room.

排除标准：

(1) 构建全麻术后低体温风险预测模型 排除标准：1.术前存在发热、低体温等非正常体温者；2.术中采取主动降温措施者；3.明确诊断为体温调节异常疾病包括恶性高热（MHS）、神经安定剂恶性综合征、汗腺功能障碍者；4.患有影响鼓膜体温测定疾病者；5.正在服用避孕药物的患者；6.有明确证据确诊的甲减或甲亢患者。 (2) 全麻术后低体温患者充气加温毯干预 排除标准：术前已存在发热或低体温等体温异常的患者；术中需进行低体温保护重要脏器者；明确诊断为汗腺功能障碍等影响正常体温调节疾病的患者；有外耳道活动性疾病而不能测量耳温者；存在热疗禁忌症者。

Exclusion criteria：

(1) Constructing a risk prediction model for hypothermia after general anesthesia. Exclusion criteria:1. Patients with abnormal body temperature such as fever or hypothermia before surgery;2. Patients who undergo active temperature reduction measures during surgery;3. Patients with a confirmed diagnosis of temperature regulation disorders, including malignant hyperthermia (MHS), neuroleptic malignant syndrome, and disorders of sweat gland function;4. Patients with diseases that affect tympanic temperature measurement;5. Patients currently taking contraceptive medications;6. Patients with a confirmed diagnosis of hypothyroidism or hyperthyroidism. (2) Intervention of heated air-filled blankets for patients with hypothermia after general anesthesia. Exclusion criteria: Patients with pre-existing fever or hypothermia and other temperature abnormalities; patients requiring hypothermic protection for important organs during surgery; patients with clearly diagnosed conditions affecting normal temperature regulation, such as sweat gland dysfunction; patients with active diseases of the external auditory canal that prevent ear temperature measurement; patients with contraindications to thermotherapy.

研究实施时间：

Study execute time：

从 From 2022-01-01 00:00:00至 To 2023-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-03-08 00:00:00 至 To 2022-09-20 00:00:00

干预措施：

Interventions：

组别：

术中低温组

样本量：

 180

Group：

intraoperative hypothermia group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NA

Intervention code：

组别：

非术中低温组

样本量：

 320

Group：

Non-intraoperative hypothermia group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NA

Intervention code：

组别：

全麻术后低体温患者常规覆盖棉被保暖（对照组）

样本量：

 40

Group：

Patients with hypothermia after general anesthesia are routinely covered with blankets for warmth (control group).

Sample size：

干预措施：

按照常规使用棉被覆盖患者身体进行保暖。

干预措施代码：

Intervention：

Cover the patient's body with a quilt for warmth as per standard practice.

Intervention code：

组别：

全麻术后低体温患者充气加温毯（试验组）

样本量：

 40

Group：

Patients with hypothermia after general anesthesia using an inflatable warming blanket (experimental group)

Sample size：

干预措施：

使用充气加温毯对患者身体进行保暖。CWS4000，由澳大利亚护理精华有限责任公司生产，加温输出温度设置为 40℃，应用配套的保温毯覆盖患者除头部以外的身体。

干预措施代码：

Intervention：

Use an inflatable warming blanket to keep the patient's body warm. The CWS4000, produced by Australian Nursing Essentials Pty Ltd, has a heating output temperature set to 40°C, and the accompanying thermal blanket is used to cover the patient's body except for the head.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

 广州市 

Country：

China

Province：

Guangdong province

City：

Guangzhou city

单位(医院)：

 广州中医药大学第一附属医院 

单位级别：

 三甲 

Institution
hospital：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

全麻患者术中低温的发生率

指标类型：

次要指标

Outcome：

Incidence of intraoperative hypothermia in elderly patients with general anesthesia

Type：

Secondary indicator

测量时间点：

测量方法：

所有的患者在进入苏醒室时即刻采用红外耳温枪记录患者鼓膜温度。根据该体温值，将体温＜36. 0℃者计入低体温组并记录低体温分级，体温≥36. 0℃计入正常体温组。

Measure time point of outcome：

Measure method：

All patients' tympanic temperatures are immediately recorded using an infrared ear thermometer upon entering the recovery room. Based on this temperature value, those with a temperature < 36.0℃ are classified into the hypothermia group and the degree of hypothermia is recorded, while those with a temperature ≥ 36.0℃ are classified into the normal temperature group.

指标中文名：

不同中医体质类型的全麻患者术后低体温发生的危险因素

指标类型：

主要指标

Outcome：

Risk factors for postoperative hypothermia in patients with different traditional Chinese medicine constitution types under general anesthesia.

Type：

Primary indicator

测量时间点：

测量方法：

术前准备时收集年龄、性别、病史回顾、体质量指数（body mass index, BMI）、 美国麻醉医师协会麻醉风险分级（ASA 分级）、手术大小分级、进入手术等侯区时的核心体温（若无手术等候区域，采集患者进入手术室时的核心体温）、中医体质类型等。

Measure time point of outcome：

Measure method：

Preoperative preparation involves collecting age, gender, medical history review, and body mass index (BMI). American Society of Anesthesiologists Anesthesia Risk Classification (ASA Classification), classification of surgical size, core body temperature upon entering the surgical waiting area (if there is no surgical waiting area, the core body temperature of the patient upon entering the operating room is collected), and traditional Chinese medicine constitution types, etc.

指标中文名：

充气加温毯干预术后低体温全麻患者的复温效果

指标类型：

主要指标

Outcome：

The effect of heated inflatable blankets on rewarming in hypothermic patients under general anesthesia after surgery.

Type：

Primary indicator

测量时间点：

测量方法：

所有纳入研究的病例均在同一麻醉恢复室进行复温。麻醉恢复室室温恒定保持 22～25℃，并在患者入麻醉恢复室时即刻测量患者耳温，对体温＜36℃的患者进行保暖复温： 充气加温毯（试验组）：CWS4000，由澳大利亚护理精华有限责任公司生产，加温输出温度设置为 40℃，应用配套的保温毯覆盖患者除头部以外的身体。 常规覆盖棉被保暖（对照组）： 按照常规使用棉被覆盖患者身体进行保暖。 两组患者核心体温达到 36℃以上时，停止复温并将充气加温毯组也改用为常规覆盖棉被保暖。

Measure time point of outcome：

Measure method：

All cases included in the study were warmed in the same anesthesia recovery room. The room temperature in the anesthesia recovery room is consistently maintained at 22-25°C, and the patient's ear temperature is measured immediately upon entering the anesthesia recovery room. Patients with a body temperature of less than 36°C are warmed and re-warmed. Inflatable heating blanket (experimental group): CWS4000, produced by Australian Nursing Essence Pty Ltd, with the heating output temperature set

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

None

Tissue：

None

人体标本去向

 其它  

说明

并没有针对该研究进行人体标本的采集

Fate of sample：

0thers  

Note：

No participants samples were collected for the study.

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 60 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）：

选择 2022 年 9 月~2022 年 10 月于广州中医药大学第一附属医院进行全身麻醉手术后，进入麻醉恢复室的患者 80 例。 将患者按照接受手术的顺序编号，并用 Microsoft Excel2016 生成随机数字与患者序号一一对应，将随机数字从小到大进行排序，平均分为两组，取两个信封分别标 1 和 2，代表充气加温毯组和常规覆盖棉被保暖组，由第三个人在不知情的情况下将两组随机数字分别放入两个信封中，对应的患者编号也被分到两组，接收患者时根据编号纳入相应组别并给予对应复温措施。

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

Number the patients in the order they receive surgery, and use Microsoft Excel 2016 to generate random numbers corresponding to the patient numbers. Sort the random numbers in ascending order, divide them into two groups, and take two envelopes labeled 1 and 2, representing the heated blanket group and the conventional blanket warming group. A third person, unaware of the group assignments, will place the two sets of random numbers into the two envelopes. The corresponding patient numbers will also be divided into the two groups. When receiving patients, assign them to the appropriate group based on their numbers and provide the corresponding rewarming measures.

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：

双盲

Blinding：

Double-Blind

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）：

1.论文成功发表后，通过联系通讯作者以合理方式获取。 2.Open Science Framework数据库，网址：https://osf.io/dashboard

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

1. After the successful publication of the paper, contact the corresponding author to obtain access in a reasonable manner. 2.Open Science Framework, https://osf.io/dashboard

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：

经病例记录表（CRF）采集患者资料后由专人统一录入数据到excel，采集的数据由专人进行管理并保存。

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

After collecting the patient information through Case Record Form(CRF), one person will uniformly input the data into Excel. The collected data shall be managed and saved by another assigned person.

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：

  2024-07-30 15:24:32