ChiCTR2500114746 版本V1.0 版本创建时间2025/12/17 11:39:32 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：

ChiCTR2500114746 

最近更新日期：

Date of Last Refreshed on：

2025-12-17 11:39:27 

注册时间：

Date of Registration：

2025-12-17 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

术中机械通气期间90%张肺有效的周期性膨肺时间间隔——一项随机偏币序贯分配试验

Public title：

Optimal Interval for Periodic Alveolar Recruitment Maneuvers Achieving 90% Lung Re-expansion During Intraoperative Mechanical Ventilation: A Randomized Biased-Coin Sequential Trial

注册题目简写：

术中机械通气期间90%张肺有效的周期性膨肺时间间隔

English Acronym：

Optimal Interval for Periodic Alveolar Recruitment Maneuvers Achieving 90% Lung Re-expansion During Intraoperative Ventilation

研究课题的正式科学名称：

术中机械通气期间90%张肺有效的周期性膨肺时间间隔——一项随机偏币序贯分配试验

Scientific title：

Optimal Interval for Periodic Alveolar Recruitment Maneuvers Achieving 90% Lung Re-expansion During Intraoperative Mechanical Ventilation: A Randomized Biased-Coin Sequential Trial

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：

谷晓珂 

研究负责人：

李宏 

Applicant：

Xiaoke Gu 

Study leader：

Hong Li 

申请注册联系人电话：

Applicant telephone：

+86 185 9587 1765

研究负责人电话：

Study leader's telephone：

+86 135 1279 7200

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：

gxiaoke2017@163.com

研究负责人电子邮件：

Study leader's E-mail：

lihong36@mail.sysu.edu.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：

广州市天河区员村二横路26号

研究负责人通讯地址：

广州市天河区员村二横路26号

Applicant address：

No. 26 Yuancun Erheng Road, Tianhe District, Guangzhou, China

Study leader's address：

No. 26 Yuancun Erheng Road, Tianhe District, Guangzhou, 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：

中山大学附属第六医院

Applicant's institution：

The Sixth Affiliated Hospital, Sun Yat-sen University

研究负责人所在单位：

中山大学附属第六医院

Affiliation of the Leader：

The Sixth Affiliated Hospital, Sun Yat-sen University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

E2025034

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：

中山大学附属第六医院医学伦理委员会

Name of the ethic committee：

Ethics Committee of the Sixth Affiliated Hospital of Sun Yat-sen University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-08-06 00:00:00

伦理委员会联系人：

吴倩

Contact Name of the ethic committee：

Qian Wu

伦理委员会联系地址：

广州市天河区员村二横路26号

Contact Address of the ethic committee：

No. 26 Yuancun Erheng Road, Tianhe District, Guangzhou, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 20 3837 9764

伦理委员会联系人邮箱：

Contact email of the ethic committee：

zslyllb@mail.sysu.cn

研究实施负责（组长）单位：

中山大学附属第六医院

Primary sponsor：

The Sixth Affiliated Hospital, Sun Yat-sen University

研究实施负责（组长）单位地址：

广州市天河区员村二横路26号

Primary sponsor's address：

No. 26 Yuancun Erheng Road, Tianhe District, Guangzhou, 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)：

广东省

市(区县)：

广州市

Country：

China

Province：

Guang Dong

City：

Guang Zhou

单位(医院)：

中山大学附属第六医院

具体地址：

广州市天河区员村二横路26号

Institution
hospital：

The Sixth Affiliated Hospital, Sun Yat-sen University

Address：

No. 26 Yuancun Erheng Road, Tianhe District, Guangzhou, China

经费或物资来源：

自筹

Source(s) of funding：

self-funding

Target disease：

atelectasis,lung-protective ventilation

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

研究设计：

偏倚化抛硬币设计 

Study design：

Biased Coin Design 

研究目的：

本研究拟探索术中机械通气期间单独应用周期性膨肺达到 90%患者张肺有效的时间间隔，以寻找腹腔镜头低位腹部大手术术中肺保护性通气更优的张肺策略。本研究的开展将有助于减少腹腔镜头低位腹部大手术患者术中肺不张和术后肺部并发症的发生，达到加速患者术后康复的目的。  

Objectives of Study：

This study aims to determine the optimal interval for periodic alveolar recruitment maneuvers (PARM) that can achieve effective lung re-expansion in 90% of patients undergoing intraoperative mechanical ventilation during abdominal laparoscopic surgery in the low Trendelenburg position. Identifying the most effective frequency of PARM is crucial for establishing lung-protective ventilation strategies, with the ultimate goal of reducing intraoperative atelectasis, decreasing postoperative pulmonary complications, and accelerating recovery.

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.择期腹腔镜头低位腹部大手术（2h<=预计手术时间<=5h） 2.术后肺部并发症中、高风险（Arozullah’s评分>=16，见附表1） 3.吸入空气时SpO2>=94% 4.年龄65-80岁

Inclusion criteria

1. Elective laparoscopic head-down major abdominal surgery (2h<=estimated operation time <=5h) 2. Moderate to high risk of postoperative pulmonary complications (Arozullah's score >=16, see Appendix 1) 3. SpO2>=94% when inhaling air 4. Age 65-80

排除标准：

1.术前1月内肺炎或>=1小时的机械通气史 2.术前12区LUS评分中单区>=2分 3.术前分流率>=10% 4.渐进性神经肌肉疾病 5.严重肺气肿/COPD、胸膜下大肺大泡（>=2cm） 6.颅内高压 7.参与了其它临床研究或拒绝参与研究

Exclusion criteria：

1. History of pneumonia or >= 1 hour of mechanical ventilation within 1 month prior to surgery 2. Preoperative LUS score of >=2 in a single zone out of 12 zones 3. Preoperative shunt rate >= 10% 4. Progressive neuromuscular disease 5. Severe emphysema/COPD, large subpleural alveoli (>=2cm) 6. Intracranial hypertension 7. Participation in other clinical studies or refusal to participate in studies

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-01 00:00:00 至 To 2026-12-31 00:00:00  

干预措施：

Interventions：

组别：

实验组

样本量：

52

Group：

Experimental group

Sample size：

干预措施：

预期膨肺时间间隔范围为10min至60 min，时间间隔差值为10 min。下一个受试者的膨肺时间间隔由前一受试者的反应决定。按照偏性掷币方法，如果一个受试者张肺无效，下一个受试者的膨肺时间间隔缩短10 min。相反，如果受试者张肺有效，则膨肺时间间隔以11%的概率延长10 min，有89%的概率保持不变。

干预措施代码：

Intervention：

The initial time interval of PARM was 0.5 hours/time, and the different interval of PARM was assigned by random partial coin sequential method.If the previous patient did not respond to postoperative assessment of lung opening, the interval between expansion of the lungs was shortened by 10 minutes for the next patient; If lung opening is effective, there is an 11% chance that the next patient will have an 10-minute expansion interval and an 89% chance that the time interval will remain unchanged.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

  

Country：

China 

Province：

Guang Dong 

City：

Guang Zhou 

单位(医院)：

中山大学附属第六医院 

单位级别：

三甲 

Institution
hospital：

The Sixth Affiliated Hospital, Sun Yat-sen University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

肺不张(以LUS和分流率联合评估)

指标类型：

主要指标

Outcome：

The effectiveness of recruitment

Type：

Primary indicator

测量时间点：

术毕（平卧，停气腹至少5分钟后，机械通气无自主呼吸，距上次膨肺达 间隔时长）

测量方法：

在手术结束时（患者仰卧位，停气腹至少5分钟后，机械通气下无自主呼吸，据上次膨肺达间隔时长），进行肺部超声检查。如果12区肺超声评分（LUS）≤1/区且分流分数<10%，则认为肺再扩张有效。

Measure time point of outcome：

At the end of surgery (with the patient in the supine position, after at least 5 minutes of apnea under mechanical ventilation without spontaneous breathing, and at the specified interval since the last recruitment maneuver)

Measure method：

At the end of surgery (with the patient in the supine position, after at least 5 minutes of apnea under mechanical ventilation without spontaneous breathing, and at the specified interval since the last recruitment maneuver), a lung ultrasound examination was performed. Lung re-expansion was considered effective if the 12-zone lung ultrasound score (LUS) was ≤1 per zone and the shunt fraction was <10%.

指标中文名：

术毕机械能

指标类型：

次要指标

Outcome：

Mechanical power at the end of surgery

Type：

Secondary indicator

测量时间点：

术毕（平卧，停气腹至少5分钟后，机械通气无自主呼吸，距上次膨肺达 间隔时长）

测量方法：

机械能的均数或中位数

Measure time point of outcome：

At the end of surgery (with the patient in the supine position, after at least 5 minutes of apnea under mechanical ventilation without spontaneous breathing, and at the specified interval since the last recruitment maneuver)

Measure method：

Mean or median mechanical power

指标中文名：

术中时间加权平均机械功

指标类型：

次要指标

Outcome：

Time-weighted average mechanical power during surgery

Type：

Secondary indicator

测量时间点：

术中

测量方法：

机械能/通气时间

Measure time point of outcome：

Intraoperative

Measure method：

Mechanical power per ventilation time

指标中文名：

术毕P/F 比率

指标类型：

次要指标

Outcome：

The P/F ratio at the end of surgery

Type：

Secondary indicator

测量时间点：

术毕（平卧，停气腹至少5分钟后，机械通气无自主呼吸，距上次膨肺达 间隔时长）

测量方法：

P/F 比率 = PaO2/FiO2 ，P/F 比率≤400提示肺不张的存在。

Measure time point of outcome：

At the end of surgery (with the patient in the supine position, after at least 5 minutes of apnea under mechanical ventilation without spontaneous breathing, and at the specified interval since the last recruitment maneuver)

Measure method：

P/F ratio = PaO? / FiO?.Statistical measure: Incidence of P/F ratio ≤400. The P/F ratio is an objective research parameter, and a P/F ratio ≤400 indicates the presence of atelectasis.

指标中文名：

术毕死腔率

指标类型：

次要指标

Outcome：

Dead space rate

Type：

Secondary indicator

测量时间点：

术毕（平卧，停气腹至少5分钟后，机械通气无自主呼吸，距上次膨肺达 间隔时长）

测量方法：

死腔率=(PaCO2-PETCO2)/PaCO2

Measure time point of outcome：

At the end of surgery (with the patient in the supine position, after at least 5 minutes of apnea under mechanical ventilation without spontaneous breathing, and at the specified interval since the last recruitment maneuver)

Measure method：

Arterial carbon dioxide partial pressure (PaCO2); partial pressure of carbon dioxide in end expiratory gas (PetCO2); Dead space fraction = (PaCO2-PetCO2)/ PaCO2.

指标中文名：

术毕吸空气试验

指标类型：

次要指标

Outcome：

Air-breathing test

Type：

Secondary indicator

测量时间点：

术毕（平卧，停气腹至少5分钟后，机械通气无自主呼吸，距上次膨肺达 间隔时长）

测量方法：

超声、血气检测完毕后，将吸入氧浓度调至21%， 5分钟后观察记录 SpO2。统计空气试验阳性（SpO2≤96%）的发生率

Measure time point of outcome：

At the end of surgery (with the patient in the supine position, after at least 5 minutes of apnea under mechanical ventilation without spontaneous breathing, and at the specified interval since the last recruitment maneuver)

Measure method：

After completion of ultrasound and arterial blood gas measurements, the inspired oxygen concentration was adjusted to 21%. SpO? was observed and recorded after 5 minutes.The incidence of a positive air-breathing test, defined as SpO? ≤96%, was recorded

指标中文名：

术中低血压

指标类型：

次要指标

Outcome：

Intraoperative hypotension

Type：

Secondary indicator

测量时间点：

术中机械通气期间

测量方法：

任何原因MAP ＜ 60 mm Hg，持续时间超过3分钟。

Measure time point of outcome：

During mechanical ventilation in the intraoperative period.

Measure method：

Defined as mean arterial pressure (MAP) <60 mmHg from any cause, lasting for more than 3 minutes.

指标中文名：

术中升压药使用

指标类型：

次要指标

Outcome：

Intraoperative vasopressor use

Type：

Secondary indicator

测量时间点：

术中机械通气期间

测量方法：

机械通气期间MAP <60mmHg且使用了任何儿茶酚胺类药物如多巴胺、肾 上腺素、去甲肾上腺素均记为该事件阳性。

Measure time point of outcome：

During intraoperative mechanical ventilation

Measure method：

Defined as any episode of MAP <60 mmHg during mechanical ventilation requiring the administration of catecholamine vasopressors, including dopamine, epinephrine, or norepinephrine. Occurrence of such an event was recorded as positive.

指标中文名：

术中轻度低氧血症

指标类型：

主要指标

Outcome：

Intraoperative mild hypoxemia

Type：

Primary indicator

测量时间点：

术中机械通气期间

测量方法：

SpO2 ≤96%，持续时间超过3分钟。

Measure time point of outcome：

During intraoperative mechanical ventilation

Measure method：

SpO? ≤96% lasting for more than 3 minutes

指标中文名：

术中重度低氧血症

指标类型：

次要指标

Outcome：

Intraoperative severe hypoxemia

Type：

Secondary indicator

测量时间点：

术中机械通气期间

测量方法：

SpO2 ≤92%，持续时间超过3分钟

Measure time point of outcome：

During intraoperative mechanical ventilation

Measure method：

SpO? ≤92% lasting for more than 3 minutes

指标中文名：

麻醉后复苏室（PACU）LUS

指标类型：

次要指标

Outcome：

Lung ultrasound score (LUS) in the post-anesthesia care unit (PACU)

Type：

Secondary indicator

测量时间点：

患者出PACU前清醒、自主呼吸状态

测量方法：

12区肺部超声评分（LUS）范围为每个区0 - 3分（总计0-36分）。评分越高，表明肺不张越严重。

Measure time point of outcome：

Awake with spontaneous breathing before discharge from the PACU

Measure method：

The 12-zone lung ultrasound score (LUS) ranges from 0 to 3 per zone (total 0–36). Higher scores indicate more severe atelectasis.

指标中文名：

PACU呼吸衰竭

指标类型：

次要指标

Outcome：

Rate of respiratory failure at post-anesthesia care unit (PACU)

Type：

Secondary indicator

测量时间点：

患者出PACU前清醒、自主呼吸状态

测量方法：

PaO2 / FiO2 < 300 mmHg，或清醒、自主吸入空气时PaO2 < 60 mmHg或 SpO2 < 90%。

Measure time point of outcome：

Stay in the PACU for at least 20 minutes and at most 3 hours; assessed at 5 to 10 minutes before leaving PACU

Measure method：

PaO?/FiO? <300 mmHg, or PaO? <60 mmHg or SpO? <90% while awake and breathing room air.

指标中文名：

术后呼吸衰竭

指标类型：

次要指标

Outcome：

Rate of postoperative respiratory failure

Type：

Secondary indicator

测量时间点：

术后第1~5天

测量方法：

PaO2 / FiO2 < 300 mmHg，或清醒、自主吸入空气时PaO2 < 60 mmHg或 SpO2 < 90%。

Measure time point of outcome：

Day1 to 5 after surgery

Measure method：

PaO?/FiO? <300 mmHg, or PaO? <60 mmHg or SpO? <90% while awake and breathing room air.

指标中文名：

术后持续性低氧血症

指标类型：

次要指标

Outcome：

Rate of sustained hypoxaemia

Type：

Secondary indicator

测量时间点：

术后第1~5天

测量方法：

连续2天随访时出现下述情形：SpO2 ≤ 92%或ΔSpO2【术前SpO2?术后 SpO2】≥ 5%）。

Measure time point of outcome：

Day1 to 5 after surgery

Measure method：

Sustained hypoxaemia, hypoxaemia at any two consecutive days; hypoxaemia: during a follow-up visit when the patient was awake and breathing room air, SpO2 ≤ 92% or the change of SpO2 (ΔSpO2, preoperative SpO2 minus postoperative SpO2) ≥ 5%.

指标中文名：

术后肺部并发症1~4级

指标类型：

次要指标

Outcome：

Postoperative pulmonary complications, Grades 1–4

Type：

Secondary indicator

测量时间点：

术后5天内

测量方法：

见附表2

Measure time point of outcome：

Day 0 to 5 after surgery

Measure method：

Operational Definitions of Postoperative Pulmonary Complications (Doi: 10.1001/jama.296.15.1851), graded on a scale from 1 to 4.

指标中文名：

术后肺部并发症2~4级

指标类型：

次要指标

Outcome：

Postoperative pulmonary complications, Grades 2–4

Type：

Secondary indicator

测量时间点：

术后5天内

测量方法：

见附表2

Measure time point of outcome：

Day 0 to 5 after surgery

Measure method：

Operational Definitions of Postoperative Pulmonary Complications (Doi: 10.1001/jama.296.15.1851), graded on a scale from 2 to 4

指标中文名：

气胸

指标类型：

次要指标

Outcome：

Pneumothorax

Type：

Secondary indicator

测量时间点：

术后7天内

测量方法：

胸膜腔内出现气体，并且脏层胸膜无血管床包绕

Measure time point of outcome：

Day 0 to 7 after surgery

Measure method：

Defined as the presence of air within the pleural cavity, with the visceral pleura not being surrounded by a vascular pattern.

指标中文名：

术后住院天数

指标类型：

次要指标

Outcome：

Postoperative hospitalization days

Type：

Secondary indicator

测量时间点：

手术日至出院当天

测量方法：

住院天数的均数或中位数

Measure time point of outcome：

Day of surgery to day of discharge

Measure method：

The duration between the operation date and the actual discharge date.

指标中文名：

术后30天内非预期入住重症监护病房（ICU）

指标类型：

次要指标

Outcome：

Unexpected admission to ICU

Type：

Secondary indicator

测量时间点：

术后30天内

测量方法：

不包括呼吸、循环稳定，神智清醒应外科医生要求进入ICU。

Measure time point of outcome：

within 30 days after surgery

Measure method：

It does not include the patients who enter ICU at the request of surgeons but have normal spontaneous breathing, stable circulation and no disturbance of consciousness

指标中文名：

术中及术后30天内死亡

指标类型：

主要指标

Outcome：

Death from any cause

Type：

Primary indicator

测量时间点：

术后30天内

测量方法：

任何原因死亡发生率

Measure time point of outcome：

Day 0 to 30 after surgery

Measure method：

Intraoperative or postoperative death from any cause

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 65 岁 years
最大 Max age 80 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）：

除外第一例张肺有效受试者外，共计44名张肺有效的受试者将纳入随机分配。偏性掷币法随机的具体操作：统计学家使用SPSS生成44个随机数（89%概率＜90，11%概率>=90）对应44个张肺有效的患者。每个张肺有效的人按顺序看对应数字，如数字>=90下一个人就缩短膨肺时间间隔10 min，如数字＜90下一个人就维持原膨肺时间间隔。

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

Excluding the first case of a subject with effective lung opening, a total of 44 subjects with effective lung opening will be included in random allocation. The specific procedure for the biased coin randomization method is as follows: The statistician uses SPSS to generate 44 random numbers (an 89% probability of being <90, and an 11% probability of being >=90) corresponding to the 44 subjects with effective lung opening. Each subject with effective lung opening will be matched sequentially with the corresponding number. If the number is >=90, the next patient's lung opening interval will be shortened by 10 minutes; if the number is <90, the next patient will maintain the original lung expansion interval.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

本研究受试者、LUS评估人员和术后肺部并发症评估人员、数据统计人员不清楚研究的分组情况。术中研究者因需进行干预措施的实施因而无法设盲。本研究随机分配信封由专人保管、分发。

Blinding：

The study subjects, LUS evaluators, postoperative pulmonary complication evaluators, and data statisticians were unclear about the study grouping. During the procedure, the investigator could not be blinded due to the intervention. Randomization envelopes for this study were kept and distributed by designated personnel.

是否共享原始数据：

IPD sharing

No

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）：

无

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

None

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：

本研究分别建立了术前基线资料病例报告表（CRF）、术中资料CRF、PACU-CRF、术后随访CRF。CRF由相应研究者填写，每个入选病例必须完成CRF。观察、记录、总结的有关要求：1. 纳入临床试验的病例在随机入组前均要求签署研究知情同意书；2. 按试验方案和观察表格认真观察记录，填写病例报告表，不得缺项；3. 认真记录受试者的膨肺情况，并详细记录未按规定膨肺的原因；4.病历与病例报告表不得随意涂改，确需更改时研究者应在涂改处签名并注明日期。 （一）数据记录 1.研究者必须保证数据真实、完整、准确。2.研究者在入组研究参与者后及时填写病例报告表或临床研究数据记录表，保证病例报告表或临床研究数据记录表上的内容与病历内容一致。3.研究者记录做任何更正时只能划线，旁注改后的数据，由研究者签名并注明日期，不得擦涂、覆盖原始记录。4.实验室检查项目齐全且均可溯源。5.每例研究参与者数据收集结束后，研究者应及时填写好病例报告表或临床研究数据记录表上相关数据，并交本中心主要研究者审核、签名确认。 （二）数据管理 1. 数据的临床研究数据记录表的填写与移交 原始记录（原始病历、检查报告单等）需妥善保存。临床研究数据记录表的数据均来源于原始病历，由研究者填写，每个入选获得编码的病例必须完成临床研究数据记录表。完成的临床研究数据记录表由主要研究者审查后交数据管理员，进行数据录入与管理工作。 2. 数据库的设计及建立 建立临床研究数据库，记录CRF表中所有的信息。数据库的格式将尽量与CRF表的格式相对应以方便录入的进行。

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

1. Data Recording (1).Researchers must ensure that the data is true, complete and accurate. (2). After enrolling the research participants, the researchers should promptly fill out the case report form or the clinical research data record form to ensure that the contents on the case report form or the clinical research data record form are consistent with the medical records. (3). When researchers make any corrections to their records, they can only underline the modified data, annotate it with the researcher's signature and date, and must not erase or cover the original records. (4). The laboratory inspection items are complete and all can be traced. (5). After the data collection for each study participant is completed, the researcher should promptly fill in the relevant data on the case report form or clinical research data record form and submit it to the principal researcher of this center for review and signature confirmation. 2.Data Management (1). Filling in and transferring the clinical research data record form Original records (such as original medical records, examination reports, etc.) should be properly kept. The data in the clinical research data record form are all derived from the original medical records and filled in by the researchers. Each case that is selected and encoded must complete the clinical research data record form. The completed clinical research data record form is reviewed by the principal investigator and then submitted to the data administrator for data entry and management. (2). Database design and establishment Establish a clinical research database and record all the information in the CRF form. The format of the database will correspond as much as possible to that of the CRF table to facilitate the input process.

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：

  2025-12-17 11:39:27