ChiCTR2300075148 版本V1.0 版本创建时间2023/08/28 09:22:55 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：

 ChiCTR2300075148 

最近更新日期：

Date of Last Refreshed on：

 2023-08-28 09:22:49 

注册时间：

Date of Registration：

 2023-08-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

插管即刻的肺复张手法对胸腔镜手术中肺萎陷的影响

Public title：

The effect of lung recruitment maneuver immediately after intubation on lung collapse in thoracoscopic surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

插管即刻的肺复张手法对胸腔镜手术中肺萎陷的影响

Scientific title：

The effect of lung recruitment maneuver immediately after intubation on lung collapse in thoracoscopic 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：

朱婕 

研究负责人：

王志华 

Applicant：

Zhu Jie 

Study leader：

Wang Zhihua 

申请注册联系人电话：

Applicant telephone：

 +86 151 2116 8197

研究负责人电话：

Study leader's
telephone：

+86 138 7601 2831

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：

 14301050112@fudan.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 wangzhihua@hainmc.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：

海南省海口市秀英区秀华路19号

研究负责人通讯地址：

海南省海口市秀英区秀华路19号

Applicant address：

19 Xiuhua Road, Xiuying District, Haikou, Hainan

Study leader's address：

19 Xiuhua Road, Xiuying District, Haikou, Hainan

申请注册联系人邮政编码：

Applicant postcode：

 570311

研究负责人邮政编码：

Study leader's postcode：

 570311

申请人所在单位：

海南省人民医院

Applicant's institution：

Hainan General Hospital

研究负责人所在单位：

海南省人民医院

Affiliation of the Leader：

Hainan General Hospital

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：

 医伦研【2023】26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：

海南省人民医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Hainan General Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-04-17 00:00:00

伦理委员会联系人：

冯颖

Contact Name of the ethic committee：

Ying Feng

伦理委员会联系地址：

海南省海口市秀英区秀华路19号

Contact Address of the ethic committee：

19 Xiuhua Road, Xiuying District, Haikou , Hainan

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 68622703

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：

海南省人民医院

Primary sponsor：

Hainan General Hospital

研究实施负责（组长）单位地址：

海南省海口市秀英区秀华路19号

Primary sponsor's address：

19 Xiuhua Road, Xiuying District, Haikou , Hainan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

海南

市(区县)：

海口

Country：

China

Province：

Hainan

City：

Haikou

单位(医院)：

海南省人民医院

具体地址：

海南省海口市秀英区秀华路19号

Institution
hospital：

Hainan General Hospital

Address：

19 Xiuhua Road, Xiuying District, Haikou , Hainan

经费或物资来源：

海南省自然科学基金委员会（批准号2019RC365）

Source(s) of funding：

Natural Science Foundation of Hainan Province(No. 2019RC365C365)

研究疾病：

需要进行肺萎陷的胸腔镜手术  

Target disease：

Thoracoscopic surgery is needed for collapsed lungs

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：

本研究的目的是对胸腔镜手术患者双肺通气期间应用肺复张手法，来探究其对术中肺萎陷的时间、质量的有效性，并评估其对术后七天肺部并发症的影响。  

Objectives of Study：

The aim of this study was to evaluate the efficacy of lung recruitment maneuver during two-lung ventilation in patients undergoing thoracoscopic surgery (Vats) on the time and quality of lung collapse during vats, and to evaluate its effect on pulmonary complications seven days after vats.

药物成份或治疗方案详述：

选取接受单肺通气的胸腔镜手术治疗的患者为研究对象，随机法进行分组，分为R组（肺复张组）和C组（对照组）。 麻醉方法：所有患者在进入手术室后快速建立静脉通路、在给予利多卡因局部麻醉后，通过对桡动脉进行穿刺来实现有创血压监测。同时连接各类生理指标监测设备，并记录心率、心电图和血氧饱和度等的实时变化情况。经由静脉通路为患者提供乳酸钠格林液后给药，为其提供液体缺失量的预补充干预，约6ml/kg。采用面罩式通氧给予早期纯氧通气储备，氧气流量设定为6 L/min，连续吸氧时间>5min。 随后开展麻醉诱导，经由静脉通路注射咪达唑仑0.05mg/kg、舒芬太尼0.5ug/kg、依托咪酯0.3mg/kg、顺苯磺酸阿曲库铵0.2mg/kg。麻醉维持：丙泊酚 4~8mg/kg/h、瑞芬太尼 0.1~1μg/kg/min（瑞芬太尼、 丙泊酚可依据术中生命体征调节）。 待麻醉药充分起效后由临床工作经验丰富的麻醉师使用左侧双腔支气管（男性37#；女性35#），借助可视喉镜进行插管操作，插管完成后使用纤维支气管镜定位（定位方法：可视纤支镜首先由右侧管腔进入，在直视气管隆突的情况下，观察到左主支气管被已充气的蓝色套囊完全封堵，蓝色套囊大部分位于左主支气管内或看到少部分蓝色边缘，右侧管腔开口通畅，可见到右肺上和中下叶开口；纤支镜进入左侧管腔，可见左肺上、下叶开口通畅。可见分泌物较多时需要进行充分的吸引。听诊双肺呼吸音均匀对称，肺隔离情况良好），待确认两侧管路均插入到合适的位置后实施双肺通气，肺复张组（R组）立即行3次手法肺复张（手法肺复张：调节呼吸机至手控模式，压力阀调整至至35~40mmHg，手控持续按压呼吸球囊，持续时间10~15s，重复3次），继续双肺通气，对照组（C组）不做处理。呼吸机通气的模式设置为容量-压力控制模式，潮气量设定为6~8ml/kg，呼吸频率设定为12~16次/分，呼气末正压指标设置在5 cmH2O，吸呼比设定为1:2，FiO2维持在100%，通气后氧气流量维持在2 L/min，维持呼气末二氧化碳35~45 mmHg之间，气道峰压< 35 cmH2O，要求双肺纯氧通气时间>10min。 待中心静脉置管后将患者置于侧卧位，再次进行纤维支气管镜定位确认双腔支气管插管位于合适位置。所有患者在外科医生切皮时刻实施呼吸管路的断开，时间为2min，后进行单侧肺叶通气模式，单侧肺通气时潮气量设定在4~6ml/kg，FiO2维持在50~70%，维持呼气末二氧化碳35~45 mmHg。打开胸膜后，当肺可见时，时间设置为T0，外科医生和另一位麻醉医生开始使用4分的Compos评分表对肺塌陷的质量进行评分，并记录肺萎陷质量、肺顺应性、BP、HR、SpO2、ETCO2、气道压等指标，此后5、10、15、20min均进行同样的评分和记录。所有数据均由不知道是否进行肺复张手法的外科医生和麻醉师使用标准化的研究病例报告表进行记录，然后输入计算机数据库。 

Description for medicine or protocol of treatment in detail：

Patients undergoing one-lung ventilation were randomly divided into two groups: Group R (lung recruitment) and Group C (control) . Anesthesia: all patients entered the operating room after the rapid establishment of intravenous access, lidocaine local anesthesia, through the radial artery puncture to achieve invasive blood pressure monitoring. At the same time, various physiological monitoring devices are connected and real-time changes of heart rate, electrocardiogram and Oxygenation are recorded. The patients were given sodium lactate green solution by intravenous route, and then the pre-supplement intervention was provided for them, about 6 ml/kg. The mask type oxygen was used to supply early pure oxygen, the oxygen flow rate was set at 6 L/min, and the continuous oxygen inhalation time was less than 5 min. Anesthesia induction was followed by intravenous midazolam of 0.05 mg/kg, sufentanil 0.5 ug/kg, etomidate 0.3 mg/kg, and atracurium maleate 0.2 mg/kg. Anesthesia Maintenance: propofol 4 ~ 8 mg/kg/h, remifentanil 0.1 ~ 1 μg/kg/min (remifentanil, propofol can be adjusted according to the intraoperative vital signs) . The left double-lumen bronchus (male 37 # ; Female 35 #) was used by an experienced anesthesiologist to intubate with the aid of a visual laryngoscope after the anesthetic fully took effect, after intubation, the left main bronchus was completely occluded by the blue sleeve, most of the blue sleeve was located in the left main bronchus or a small part of the blue edge was seen. The opening of the right lumen was unobstructed, and the openings of the right upper and middle and lower lobes were visible. It can be seen that more secretions need to be fully attracted. Auscultation of both lungs breathing sound even symmetry, lung isolation is good) , two-lung ventilation should be performed after confirmation that both side tubes are inserted in proper positions, in Group R, three times of manual lung recruitment were performed immediately (manual lung recruitment: adjusting the ventilator to manual mode, adjusting the pressure valve to 35 ~ 40mmHg, and pressing the breathing balloon with manual control for 10 ~ 15s, repeated three times) , the control group (Group C) was not treated. The mode of ventilator ventilation was volume-pressure control mode, tidal volume was set at 6 ~ 8 ml/kg, respiratory rate was set at 12 ~ 16 times/min, positive end-expiratory pressure was set at 5 cmH2O, respiratory ratio was set at 1:2, fIO2 was maintained at 100% , oxygen flow was maintained at 2 L/min after ventilation, end-expiratory carbon dioxide was maintained between 35 ~ 45 mmHg, peak airway pressure was 35 cmH2O, and pure oxygen ventilation was required for 10 min. After central venous catheterization, the patient was placed in the lateral position and repositioned by fiberoptic bronchoscopy to confirm the proper position of double-lumen endobronchial intubation. At the time of skin incision, the respiratory tube was cut off for 2 minutes and then one-lung ventilation was performed. The tidal volume was set at 4 ~ 6 ml/kg and Fio2 was maintained at 50 ~ 70% during one-lung ventilation, the end-expiratory carbon dioxide was maintained at 35 ~ 45 mmHg. After opening the pleura, when the lungs were visible and time set to T 0, the surgeon and another anesthesiologist began to score the quality of the lung collapse using a Compos score sheet of 4 points; The index of lung collapse, lung compliance, BP, HR, SPO2, etco2 and airway pressure were recorded, and the same score and record were made at 5,10,15 and 20 min later. All data were recorded by surgeons and anesthesiologists who were not aware of whether a pulmonary recruitment maneuver was performed using a standardized study case report form and then entered into a computer database. 

纳入标准：

1、ASA：Ⅰ-Ⅲ级；2、年龄18~65岁；3、BMI<30kg/m2；4、全麻，双腔支气管插管，预计将进行拔管的择期胸腔镜手术

Inclusion criteria

1、 Asa: I-III; 2、 Age 18-65 years; 3、 BMI<30kg/m2 4、 general anesthesia, double lumen endobronchial intubation, it is expected to extubate thoracoscopic surgery

排除标准：

1、任何原因不能配合研究或研究者认为不宜纳入本试验；2、有严重慢性阻塞性肺疾病史、胸膜粘连、肺部炎症、间质性肺病史、肺气肿、气胸、胸部放疗史等；3、合并严重心、脑、肝、肾疾病者（需住院治疗的疾病）；4、孕期、哺乳期女性。

Exclusion criteria：

1. Any reason can not cooperate with the research or the researcher thinks it is not suitable to be included in this experiment; 2.History of severe chronic obstructive pulmonary disease, pleural adhesion, pulmonary inflammation, Interstitial lung disease, emphysema, pneumothorax, chest radiotherapy, etc. 3. Patients with severe heart, brain, liver and kidney diseases (diseases requiring hospitalization) 4. Pregnant and lactating women.

研究实施时间：

Study execute time：

从 From 2023-09-01 00:00:00至 To 2024-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-09-01 00:00:00 至 To 2024-06-30 00:00:00

干预措施：

Interventions：

组别：

肺复张组

样本量：

 30

Group：

Lung Recruitment Group ( R Group)

Sample size：

干预措施：

插管后即刻的肺复张手法

干预措施代码：

Intervention：

Lung recruitment maneuver immediately after intubation

Intervention code：

组别：

对照组

样本量：

 30

Group：

Control Group ( C Group)

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 海南 

市(区县)：

 海口 

Country：

China

Province：

Hainan

City：

Haikou

单位(医院)：

 海南省人民医院 

单位级别：

 三甲 

Institution
hospital：

Hainan General Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

肺萎陷达到满意程度时的时间

指标类型：

主要指标

Outcome：

Collapse time of lung

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术中血气分析指标

指标类型：

次要指标

Outcome：

Blood gas analysis index during 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：

肺萎陷质量评分

指标类型：

次要指标

Outcome：

Lung collapse quality score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肺顺应性

指标类型：

次要指标

Outcome：

Lung compliance

Type：

Secondary 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：

动脉血

组织：

Sample Name：

Arterial 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 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）：

使用SPSS进行简单随机分组

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

Simple randomization using SPSS

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：

装有随机信息的不透明信封被放置在麻醉机的一侧，以保持手术团队对分组分配的盲化，术中结果的评定由不知道分组的手术团队和另一名麻醉师进行。24小时后，所有数据均由研究人员在不知道分组分配的情况下获得。术后数据由盲法结果评估者收集。参与者、统计者、病房和术后护理单位（PACU）的工作人员对分组情况也不知情。

Blinding：

An opaque envelope with random information was placed on one side of the anesthesia machine to keep the surgical team blind to grouping assignments, and assessment of intraoperative outcomes was performed by the surgical team and another anesthesiologist who were unaware of the grouping. After 24 hours, all data were obtained by the researchers without knowing the group assignments. Postoperative data were collected by blinded outcome assessors. Participants, statisticians, and staff in the ward and postoperative care unit (PACU) were also blinded to the 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）：

试验完成后6个月内ResMan， Http://www.medresmen.org.cn

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

Within six months after thetrial comlete ResMan, Http://www.medresmen.org.cn

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：

病例记录表（Case Record Form, CRF）和ResMan

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

Case Record Form and ResMan

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-08-28 09:22:49