今天是:2020-08-03 星期一

序贯法测定全身麻醉诱导期面罩通气致食管进气的半数有效气道峰压
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注册号:

Registration number:

ChiCTR2000034633 

最近更新日期:

Date of Last Refreshed on:

2020-07-13 

注册时间:

Date of Registration:

2020-07-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

序贯法测定全身麻醉诱导期面罩通气致食管进气的半数有效气道峰压 

Public title:

The median effective dose of peak airway pressure in left paratracheal esophagus insufflation of air induction of anesthesia with Dixon’s Up-and-Down method:A Prospective, Randomized, single-Blind Study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

序贯法测定全身麻醉诱导期面罩通气食管进气的半数有效气道峰压 

Scientific title:

A sequential method was used to determine half of the effective peak airway pressure of mask ventilation esophageal intake during the induction period of general anesthesia 

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:

邓威 

研究负责人:

邓威 

Applicant:

Wei Deng 

Study leader:

Wei Deng 

申请注册联系人电话:

Applicant telephone:

+86 19884340796 

研究负责人电话:

Study leader's telephone:

+86 19884340796 

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:

dengwei1992868@163.com 

研究负责人电子邮件:

Study leader's E-mail:

dengwei1992868@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:

浙江省嘉兴市中环南路1882号 

研究负责人通讯地址:

浙江省嘉兴市中环南路1882号 

Applicant address:

1882 Zhonghuan Road South, Jiaxing, Zhejiang, China 

Study leader's address:

1882 Zhonghuan Road South, Jiaxing, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

314000 

研究负责人邮政编码:

Study leader's postcode:

314000 

申请人所在单位:

浙江省嘉兴市嘉兴第一医院 

Applicant's institution:

Jiaxing First 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:

LS2018-278 

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:

嘉兴第一医院伦理委员会 

Name of the ethic committee:

Ethics committee of Jiaxing First Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-12-14 

伦理委员会联系人:

李振平 

Contact Name of the ethic committee:

Zhen-ping Li 

伦理委员会联系地址:

浙江省嘉兴市中环南路1882号 

Contact Address of the ethic committee:

1882 Zhonghuan Road South, Jiaxing, Zhejiang, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 18207735634 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

dengwei1992868@163.com 

研究实施负责(组长)单位:

浙江省嘉兴市嘉兴第一医院 

Primary sponsor:

Jiaxing First Hospital 

研究实施负责(组长)单位地址:

浙江省嘉兴市中环南路1882号 

Primary sponsor's address:

1882 Zhonghuan Road South, Jiaxing, Zhejiang, 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):

浙江省

市(区县):

嘉兴市

Country:

China

Province:

Zhejiang

City:

Jiaxing

单位(医院):

嘉兴学院附属医院

具体地址:

浙江省嘉兴市中环南路1882号

Institution
hospital:

Affiliated Hospital of Jiaxing University

Address:

1882 Zhonghuan Road South

经费或物资来源:

嘉兴市第一医院麻醉科 

Source(s) of funding:

Department of anesthesiology, Jiaxing First Hospital 

研究疾病:

全身麻醉诱导期食道进气 

Target disease:

Esophagus intake during induction of general anesthesia 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

使用超声实时监测颈部食管进气,来测定全身麻醉诱导期面罩压力通气致食管进气的半数有效气道峰压 

Objectives of Study:

The cervical esophageal intake was monitored by ultrasound in real time to determine the effective airway peak pressure of half of the esophageal intake induced by mask pressure ventilation during the induction period of general anesthesia 

药物成份或治疗方案详述:

择期接受全身麻醉的手术患者45例,ASAⅠ~Ⅱ级,体重指数(BMI)﹤26kg/m2。麻醉诱导后以压力控制模式进行面罩通气,并使用超声实时监测颈部食管进气的情况。通气前后,超声测量胃窦横截面积(Cross Sectional Area, CSA)。采用序贯法进行试验,第1例患者起始通气压力为15cmH2O,压力分级为1 cmH2O。在通气过程,若发现食管口有强回声气体声影进入,认定为食管进气阳性,则下一例采用低一级通气压力;若未发现强回声气体声影进入食管,机械通气2分钟后进行气管插管,则下一例采用高一级通气压力。记录该面罩压力通气末的气道峰压(Ppeak)、呼出潮气量(VTe)、呼气末二氧化碳分压(PETCO2)及呼气末氧浓度(etO2)。记录通气前后胃窦横截面积(CSA)。采用概率单位回归法计算食管进气的半数有效气道峰压(half-effective airway peak pressure, EPpeak50)及其95 %可信区间(95% confidence interval , 95% CI)。结果:所有患者均顺利完成研究。麻醉诱导期间面罩压力通气致食管进气的EPpeak50及95%CI分别为13.4 cmH2O和12.0~14.7cmH2O。食管进气阳性组通气后胃窦横截面积明显大于阴性组(P﹤0.05) 

Description for medicine or protocol of treatment in detail:

Names of 45 cases of general anesthesia surgery patients, ASA Ⅰ ~ Ⅱ level, body mass index (BMI) ﹤ 26 kg/m2.After anesthesia induction, mask ventilation was performed in pressure control mode, and cervical esophageal intake was monitored by ultrasound in real time.Procedures Before and after ventilation, Cross Sectional Area (CSA) was measured by ultrasound.Sequential method was used for the experiment. The initial ventilation pressure of the first patient was 15cmH2O, and the pressure grading was 1 cmH2O.In the process of ventilation, if strong echo gas acoustic shadow is found to enter the esophageal mouth and it is determined to be positive for esophageal intake, the next case adopts lower ventilation pressure.If no strong echo gas acoustic shadow is found to enter the esophagus and endotracheal intubation is performed 2 minutes after mechanical ventilation, a higher ventilation pressure is applied in the next case.Airway peak pressure (Ppeak), exhaled tidal volume (VTe), end-expiratory carbon dioxide (PETCO2) and end-expiratory oxygen concentration (etO2) were recorded.Antrum cross-sectional area (CSA) before and after ventilation was recorded.Calculate the half-effective Airway Peak pressure (EPpeak50) and its 95%Confidence interval (95%CI) by using the probability unit regression method.Results: All patients completed the study successfully.The EPpeak50 and 95%CI of esophageal intake induced by mask pressure ventilation during anesthesia induction were 13.4 cmH2O and 12.0~14.7cmH2O, respectively.The antrum cross-sectional area after ventilation in the positive group was significantly larger than that in the negative group (P < 0.05). 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

选择2020年03月在嘉兴市第一医院行全身麻醉患者40例,ASA 分级Ⅰ~Ⅱ级,年龄18~80岁,体重指数(BMI)﹤26kg/m2。 

Inclusion criteria

Select 2020 March in line, the first hospital of jiaxing city 40 cases of patients with general anesthesia, ASA class I - II, aged 18 to 80 years old, body mass index (BMI) ﹤ 26 kg/m2. 

排除标准:

留置胃管患者,存在明确误吸风险患者,口咽和颜面部疾病者,鼻息肉患者。 

Exclusion criteria:

Patients with indwared gastric tube, patients with definite risk of aspiration, oropharyngeal and facial diseases, and patients with nasal polyps. 

研究实施时间:

Study execute time:

From2019-07-12To 2020-07-15 

征募观察对象时间:

Recruiting time:

From2020-07-12To 2020-07-15 

干预措施:

Interventions:

组别:

Case series

样本量:

40

Group:

Case series

Sample size:

干预措施:

降低或者升高气道压

干预措施代码:

Intervention:

Lower or increase airway pressure

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江省 

市(区县):

嘉兴市 

Country:

China 

Province:

Zhejiang 

City:

Jiaxing 

单位(医院):

嘉兴学院附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Jiaxing University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

通气末的气道峰压

指标类型:

主要指标 

Outcome:

Peak airway pressure at the end of ventilation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼出潮气量

指标类型:

主要指标 

Outcome:

Exhaled tidal volume

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼气末二氧化碳分压

指标类型:

主要指标 

Outcome:

Pco2 at end of breath

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼气末氧浓度

指标类型:

次要指标 

Outcome:

Oxygen concentration at the end of breath

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

通气前后胃窦横截面积

指标类型:

主要指标 

Outcome:

Antrum cross-sectional area before and after ventilation

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:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

N/A

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

ResMan (www.medresman.org)

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

ResMan (www.medresman.org)

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

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

Medical record

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-07-12
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