ChiCTR2600118704 版本V1.0 版本创建时间2026/02/10 10:35:28 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：

 ChiCTR2600118704 

最近更新日期：

Date of Last Refreshed on：

 2026-02-10 10:35:18 

注册时间：

Date of Registration：

 2026-02-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

肺超声指导个体化肺保护通气对腹腔镜手术患者肺不张的影响

Public title：

The Effect of Lung Ultrasound-Guided Individualized Lung-Protective Ventilation on Atelectasis in Patients Undergoing Laparoscopic Surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

肺超声指导个体化肺保护通气对腹腔镜手术患者肺不张的影响

Scientific title：

The Effect of Lung Ultrasound-Guided Individualized Lung-Protective Ventilation on Atelectasis in Patients Undergoing Laparoscopic Surgery

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：

郑镇伟 

研究负责人：

郑镇伟 

Applicant：

Zhenwei Zheng 

Study leader：

Zhenwei Zheng 

申请注册联系人电话：

Applicant telephone：

 +86 138 2280 3033

研究负责人电话：

Study leader's
telephone：

+86 138 2280 3033

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：

 wind_8228@163.com

研究负责人电子邮件：

Study leader's E-mail：

 wind_8228@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：

广东省汕头市金平区东厦北路69号

研究负责人通讯地址：

广东省汕头市金平区东厦北路69号

Applicant address：

69 Dongsha Road North, Shantou, Guangdong, China

Study leader's address：

69 Dongsha Road North, Shantou, Guangdong, China

申请注册联系人邮政编码：

Applicant postcode：

 515041

研究负责人邮政编码：

Study leader's postcode：

 515041

申请人所在单位：

汕头大学医学院第二附属医院

Applicant's institution：

The Second Affiliated Hospital of Shantou University Medical College

研究负责人所在单位：

汕头大学医学院第二附属医院

Affiliation of the Leader：

The Second Affiliated Hospital of Shantou University Medical College

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：

 汕大医附二伦审科(2026-19)号

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：

汕头大学医学院第二附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Second Affiliated Hospital of Shantou University Medical College

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-01-26 00:00:00

伦理委员会联系人：

杨翠丹

Contact Name of the ethic committee：

Cuidan Yang

伦理委员会联系地址：

广东省汕头市金平区东厦北路

Contact Address of the ethic committee：

Dongxia North Road, Jinping District, Shantou, Guangdong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 754 8891 5938

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：

汕头大学医学院第二附属医院

Primary sponsor：

The Second Affiliated Hospital of Shantou University Medical College

研究实施负责（组长）单位地址：

广东省汕头市金平区东厦北路69号

Primary sponsor's address：

69 Dongsha Road North, Shantou, Guangdong, 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)：

汕头市

Country：

China

Province：

Guangdong Province

City：

Shantou

单位(医院)：

汕头大学医学院第二附属医院

具体地址：

汕头市金平区东厦北路69号

Institution
hospital：

The Second Affiliated Hospital of Shantou University Medical College

Address：

69 Dongsha Road North, Shantou

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

术后肺部并发症  

Target disease：

Postoperative pulmonary complications

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：

主要目的：比较肺超声指导的个体化肺保护通气与传统固定参数肺保护通气对腹腔镜手术患者术后肺不张的影响。 次要目的：比较肺超声指导的个体化肺保护通气与传统固定参数肺保护通气对腹腔镜手术患者术后住院时间及并发症（如肺部感染、低氧血症）发生率的影响。  

Objectives of Study：

Primary objective: To compare the effects of lung ultrasound-guided individualized lung-protective ventilation with conventional fixed-parameter lung-protective ventilation on postoperative atelectasis in patients undergoing laparoscopic surgery. Secondary objective: To compare the effects of lung ultrasound-guided individualized lung-protective ventilation with conventional fixed-parameter lung-protective ventilation on postoperative hospital stay and the incidence of complications (such as pulmonary infection and hypoxemia) in patients undergoing laparoscopic surgery.

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. ASA分级Ⅰ～Ⅲ级；2. 18岁≤年龄≤65岁；3. 在腹腔镜下行胆囊或阑尾切除或疝修补手术的患者。

Inclusion criteria

1. American Society of Anesthesiologists (ASA) class I to III; 2. Aged 18 to 65 years (inclusive); 3. Patients undergoing laparoscopic cholecystectomy, appendectomy, or herniorrhaphy

排除标准：

1. 患者拒绝；2. ASA分级＞Ⅲ级；3. BMI≥30 kg/m2；4. 急诊手术；5. 近期（6个月内）有胸腔手术史；6. 术前已知严重心脏疾病，包括但不限于严重心脏瓣膜病变、严重心肌病、严重冠状动脉狭窄、不稳定性心绞痛病史、严重心功能不全（NYHA分级Ⅲ级或Ⅳ级）等；7. 术前合并慢性肺部疾病，包括但不限于慢性阻塞性肺疾病、支气管扩张、哮喘、多发肺大泡或单个肺大泡＞3 cm、间质性肺炎、肺心病等；8. 术前合并严重低蛋白血症、低氧血症、Hb＜80 g/L、胸廓或胸椎脊柱畸形影响通气；9. 有精神疾病史或认知功能障碍。

Exclusion criteria：

1. Refusal of participation by the patient; 2. American Society of Anesthesiologists (ASA) class > Ⅲ; 3. Body mass index (BMI) >= 30 kg/m2; 4. Emergency surgery; 5. A history of thoracic surgery within the recent 6 months; 6. Preoperatively known severe cardiac diseases, including but not limited to severe valvular heart disease, severe cardiomyopathy, severe coronary artery stenosis, a history of unstable angina pectoris, severe cardiac insufficiency (New York Heart Association (NYHA) functional class Ⅲ or Ⅳ), etc; 7. Preoperative comorbidity of chronic pulmonary diseases, including but not limited to chronic obstructive pulmonary disease (COPD), bronchiectasis, asthma, multiple pulmonary bullae or a single pulmonary bulla > 3 cm in diameter, interstitial pneumonia, cor pulmonale, etc; 8. Preoperative comorbidity of severe hypoproteinemia, hypoxemia, hemoglobin (Hb) < 80 g/L, or thoracic/vertebral spinal deformities affecting ventilation; 9. A history of mental illness or cognitive impairment.

研究实施时间：

Study execute time：

从 From 2026-02-12 00:00:00至 To 2028-04-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-02-12 00:00:00 至 To 2027-08-31 00:00:00

干预措施：

Interventions：

组别：

A组

样本量：

 54

Group：

Group A

Sample size：

干预措施：

全麻机械通气期间通气模式设为容量控制通气（VCV）+全程采用VT 7ml/kg（理想体重）+手法肺复张。手法肺复张操作方法：先设置逸气阀开放压为15 cmH2O，缓慢挤压球囊，逐步增加压力限制，每次增加5 cmH2O，速度控制在每3～5 s增加5 cmH2O直到30 cmH2O，停留30 s，确保肺泡充分复张。之后再逐步降低压力，每2～3 s下降5 cmH2O，避免肺泡再次塌陷。

干预措施代码：

Intervention：

During general anesthesia with mechanical ventilation, the ventilation mode is set to volume-controlled ventilation (VCV). A tidal volume (VT) of 7 ml/kg of ideal body weight is used throughout. Manual lung recruitment is performed. The method for manual lung recruitment is as follows: first, set the spill valve opening pressure to 15 cmH2O, then slowly squeeze the bag, gradually increasing the pressure limit by 5 cmH2O each time, controlling the increase at a rate of 5 cmH2O every 3–5 seconds until reaching 30 cmH2O, and maintain for 30 seconds to ensure full alveolar recruitment. Then gradually reduce the pressure, decreasing by 5 cmH2O every 2–3 seconds to avoid alveolar collapse.

Intervention code：

组别：

B组

样本量：

 54

Group：

Group B

Sample size：

干预措施：

全麻机械通气期间通气模式设为容量控制通气（VCV）+全程采用VT 7ml/kg（理想体重）+5 cmH2O PEEP +手法肺复张。

干预措施代码：

Intervention：

During general anesthesia with mechanical ventilation, the ventilation mode was set to volume-controlled ventilation (VCV), using a tidal volume of 7 ml/kg (ideal body weight), 5 cmH2O PEEP, and manual lung recruitment throughout.

Intervention code：

组别：

C组

样本量：

 54

Group：

Group C

Sample size：

干预措施：

全麻机械通气期间通气模式设为容量控制通气（VCV）+全程采用VT 7ml/kg（理想体重）+5 cmH2O PEEP +超声指导下肺复张。

干预措施代码：

Intervention：

During general anesthesia with mechanical ventilation, the ventilation mode is set to volume-controlled ventilation (VCV). Throughout the procedure, VT is 7 ml/kg (ideal body weight) with 5 cmH2O PEEP. Lung recruitment is guided by ultrasound.

Intervention code：

组别：

D组

样本量：

 54

Group：

Group D

Sample size：

干预措施：

全麻机械通气期间通气模式设为容量控制通气（VCV）+全程采用VT 7ml/kg（理想体重）+超声指导下设置个体化PEEP（iPEEP）+超声指导下肺复张。超声指导下肺复张并设置iPEEP操作方法：选择肺不张程度最重的肺窗作为肺超声滴定iPEEP的扫查点。驱动压力恒定为15 cmH2O，将呼吸频率下调至4次/分，保持7～8 s的吸气时间。初始PEEP设置为5 cmH2O。每3次呼吸增加5 cmH2O PEEP，从5 cmH2O逐步增加至肺超声无肺不张影像时的PEEP水平，为防止气压伤，PEEP最高不超过20 cmH2O。在每个PEEP水平下，保持3次呼吸。达到目标复张压力：当PEEP达到肺超声图像无肺不张影像时，继续保持驱动压力为15 cmH2O，维持该压力水平进行10次呼吸。从该水平的PEEP以2～3 cmH2O幅度下调PEEP，每次暂停3～5 min以观察肺部超声图像的变化，直至该肺窗再次出现肺不张超声影像，此时PEEP认定为肺泡重现塌陷的临界值，在此基础上增加PEEP 1 cmH2O，若超声图像仍为肺不张影像，则在临界值PEEP基础上增加2 cmH2O，此时的PEEP水平被认为是iPEEP。

干预措施代码：

Intervention：

During general anesthesia with mechanical ventilation, the ventilation mode was set to volume-controlled ventilation (VCV) throughout the procedure, using a tidal volume (VT) of 7 ml/kg (ideal body weight). Individualized PEEP (iPEEP) was set under ultrasound guidance, and lung recruitment was performed under ultrasound guidance. Method for ultrasound-guided lung recruitment and iPEEP setting: Select the lung window with the most severe atelectasis as the scanning point for ultrasound-guided iPEEP titration. Keep the driving pressure constant at 15 cmH2O and reduce the respiratory rate to 4 breaths per minute, maintaining an inspiratory time of 7–8 seconds. The initial PEEP was set at 5 cmH2O. Increase PEEP by 5 cmH2O every 3 breaths, gradually raising it from 5 cmH2O until no atelectasis is seen on lung ultrasound, with a maximum PEEP of 20 cmH2O to prevent barotrauma. At each PEEP level, maintain for 3 breaths. Achieve target recruitment pressure: once PEEP reaches the level where the lung ultrasound shows no atelectasis, continue to keep the driving pressure at 15 cmH2O and maintain this pressure for 10 breaths. Then decrease PEEP from this level in steps of 2–3 cmH2O, pausing for 3–5 minutes each time to observe changes in lung ultrasound images, until atelectasis reappears in that lung window. At this point, PEEP is considered the critical value for alveolar derecruitment; increase PEEP by 1 cmH2O from this baseline. If ultrasound still shows atelectasis, increase the PEEP by 2 cmH2O from the critical value. The resulting PEEP level is considered the iPEEP.

Intervention code：

组别：

E组

样本量：

 54

Group：

Group E

Sample size：

干预措施：

全麻机械通气期间通气模式设为容量保证压力控制通气（PCV-VG）+全程采用VT 7ml/kg（理想体重）+超声指导下设置个体化PEEP +超声指导下肺复张。

干预措施代码：

Intervention：

During general anesthesia mechanical ventilation, the ventilation mode is set to pressure-controlled ventilation with volume guarantee (PCV-VG). A tidal volume of 7 ml/kg (ideal body weight) is used throughout. Individualized PEEP is set under ultrasound guidance. Lung recruitment is performed under ultrasound guidance.

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)：

 汕头市 

Country：

China

Province：

Guangdong

City：

Shantou

单位(医院)：

 汕头大学医学院第二附属医院 

单位级别：

 三级甲等 

Institution
hospital：

The Second Affiliated Hospital of Shantou University Medical College

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

肺部超声评分

指标类型：

次要指标

Outcome：

Lung ultrasound score

Type：

Secondary indicator

测量时间点：

术前，拔管后20分钟，术后48h

测量方法：

采用十二分区法检查，每侧由胸骨旁线、腋前线、腋后线将胸廓分成前、侧、后三个区，再以乳头连线水平分为上、下两部分，即双肺按体表标志共分为十二区。使用B超进行肺部超声检查。

Measure time point of outcome：

Preoperative , 20 minutes after extubation under general anesthesia, and 48 hours after surgery

Measure method：

The 12-zone scanning method was adopted for lung ultrasonography. The thoracic cage on each side was divided into the anterior, lateral and posterior regions by the parasternal line, anterior axillary line and posterior axillary line, and further subdivided into the upper and lower segments at the level of the nipple line. Thus, the bilateral lungs were divided into a total of 12 zones based on somatic landmarks. Lung ultrasonography was performed using a B-mode ultrasound scanner.

指标中文名：

术后肺部并发症

指标类型：

次要指标

Outcome：

Postoperative pulmonary complications(PPCs)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术中呼吸力学参数

指标类型：

次要指标

Outcome：

Intraoperative respiratory mechanics parameters

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术中血流动力学

指标类型：

次要指标

Outcome：

Intraoperative hemodynamics

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

PACU停留时间

指标类型：

次要指标

Outcome：

PACU length-of-stay

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后带管时间

指标类型：

次要指标

Outcome：

the time of patient with intubation post-operation

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后住院时间

指标类型：

次要指标

Outcome：

Postoperative hospital stay

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后3天内肺不张发生率

指标类型：

主要指标

Outcome：

Incidence of atelectasis within 3 days after surgery

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肺不张严重程度

指标类型：

主要指标

Outcome：

Severity of atelectasis

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 65 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）：

采用分层随机化方法，以“手术类型（腹腔镜胆囊切除/阑尾切除/疝修补）”和“ASA分级（Ⅰ/Ⅱ/Ⅲ 级）”为分层因素，确保不同手术类型与基础病情的患者在各组间均衡分布。由统计分析人员使用SPSS软件生成随机数字表，根据分层因素分配随机号，按1:1:1:1:1的比例随机分配至A、B、C、D、E五个组。

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

Stratified randomization was performed by stratifying for surgical type (laparoscopic cholecystectomy/appendectomy/herniorrhaphy) and ASA physical status (Ⅰ/Ⅱ/Ⅲ), to balance patient distribution across groups. A random number table was created via SPSS by a statistician, and patients were randomly assigned to Groups A, B, C, D, E at a 1:1:1:1:1 ratio based on stratification factors.

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：

采用评估者和患者盲法（双盲）。由于不同组间通气模式（VCV/PCV-VG）、PEEP设置及肺复张方式存在明显差异，无法对麻醉医师（干预实施者）实施盲法，但对以下人员设盲：患者，肺超声评估人员，数据统计分析人员，术后随访人员。

Blinding：

A double-blind method was adopted, with both the evaluators and patients blinded. Due to significant differences in ventilation modes (VCV/PCV-VG), PEEP titration, and lung recruitment methods among different groups, blinding could not be implemented for anesthesiologists (intervention implementers). However, blinding was applied to the following personnel: patients, lung ultrasound evaluators, data statisticians, and postoperative follow-up personnel.

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

否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：

数据采集使用病例记录表的方式，数据的管理采用电子管理系统，由一位研究人员进行数据汇总和分类，制成数据汇总表并保存。

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

Data were collected using a case report form (CRF), and data management was conducted via an electronic data management system (EDMS). A single researcher was responsible for data aggregation and classification, which were compiled into a data summary table and stored for subsequent analysis.

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：

  2026-02-10 10:35:18