ChiCTR2200056399 版本V1.0 版本创建时间2022/09/27 10:14:56 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：

 ChiCTR2200056399 

最近更新日期：

Date of Last Refreshed on：

 2022-02-05 10:07:06 

注册时间：

Date of Registration：

 2022-02-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

指夹式脉搏血氧仪脉搏血氧饱和度验证临床试验

Public title：

Validation for Pulse Saturation Accuracy of Pulse Oximeters

注册题目简写：

English Acronym：

研究课题的正式科学名称：

脉搏血氧饱和度验证临床试验

Scientific title：

Validation for Pulse Saturation Accuracy of Pulse Oximeters

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：

谢光健 

研究负责人：

韩伟 

Applicant：

XieGuangJian 

Study leader：

HanWei 

申请注册联系人电话：

Applicant telephone：

 18664089555

研究负责人电话：

Study leader's
telephone：

18813980300

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：

 858683903@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 18813980300@139.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：

深圳市南山区西丽街道阳光社区松白路1002号百旺信工业园19栋101-501，21栋

研究负责人通讯地址：

深圳大学总医院

Applicant address：

19th Building101-501,21th Building, Baiwangxin lndustrial Park, Songbai Rd1002., Xili, Nanshan Shenzhen China

Study leader's address：

SHENZHEN UNIVERSITY GENERAL HOSPITAL

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：

深圳市华盛昌科技实业股份有限公司

Applicant's institution：

Shenzhen Everbest Machinery lndustry Co., Ltd.

研究负责人所在单位：

Affiliation of the Leader：

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：

 2021-001QX-01

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：

深圳大学总医院药物/医疗器械临床试验专业伦理委员会

Name of the ethic committee：

Ethics Committee Office Of SHENZHEN UNIVERSITY GENERAL HOSPITAL

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-09-01 00:00:00

伦理委员会联系人：

蔡云婷

Contact Name of the ethic committee：

CaiYunTing

伦理委员会联系地址：

深圳大学总医院

Contact Address of the ethic committee：

SHENZHEN UNIVERSITY GENERAL HOSPITAL

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

深圳大学总医院

Primary sponsor：

SHENZHEN UNIVERSITY GENERAL HOSPITAL

研究实施负责（组长）单位地址：

深圳市西丽大学城学苑大道1098号

Primary sponsor's address：

No.1098,Xueyuan Rd.,Xili University Town,Shenzhen

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

深圳

市(区县)：

Country：

China

Province：

Shenzhen

City：

单位(医院)：

深圳大学总医院

具体地址：

西丽大学城学苑大道1098号

Institution
hospital：

SHENZHEN UNIVERSITY GENERAL HOSPITAL

Address：

1098 Xueyuan Rd., Xili University Town

经费或物资来源：

深圳市华盛昌科技实业股份有限公司

Source(s) of funding：

Shenzhen Everbest Machinery lndustry Co., Ltd.

研究疾病：

不适用  

Target disease：

Not Applicable

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：

 其它 

Study phase：

N/A

研究设计：

单臂 

Study design：

Single arm 

研究目的：

根据YY 0784-2010 《医用电气设备医用脉搏血氧仪设备基本安全和主要性能专用要求》（2012年6月1日实施）第50.101条款及2016年02月18日国家食品药品监管总局发布的《脉搏血氧仪设备临床评价技术指导原则》的要求，ISO 80601-2-61:2011脉氧仪设备基本安全和基本性能的特殊要求，进行脉搏血氧饱和度准确度的临床验证，同时验证产品的安全性、有效性。  

Objectives of Study：

To verify the accuracy of pulse oximetry and the safety and validity of the product in accordance with Article 50.101 of YY 0784-2010 Medical Electrical Equipment - Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical Use (implemented on June 1, 2012), the Technical Guidelines for Clinical Evaluation of Pulse Oximeters issued by State Food and Drug Administration on February 18, 2016 and ISO 80601-2-61:2011 Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for the clinical veriifcation of the accuracy, safety and effectiveness of Pulse Oxygen Saturation.

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）年龄在18~50周岁的健康成年人（男女不限，包含深、中、浅三种典型肤色，应至少有2名或者15%深色皮肤人种）；
2）生命体征、体格检查、12-导联心电图、胸片、实验室检查（包括血常规、尿常规、凝血功能、血生化等功能）均正常或异常无临床意义；
3）同意自愿参加本试验，并签署知情同意书;
4）在呼吸空气下的脉血气分析：SaO2 > 95%；COHb<3%，MetHb<2%，ctHb>10g/dl；

Inclusion criteria

1) Healthy adults between age 18 and 50 (male and female, including dark, medium and light skin, should have at least 2 person or 15% people are dark-skinned);
2) Normal or abnormal vital signs, physical examination, 12-lead electrocardiogram, chest X-ray, laboratory examination (including blood routine, urine routine, coagulation function, blood biochemistry and other functions) have no clinical significance;
3) Agree to participate in the study voluntarily and sign the Informed Consent Form;
4) Artery Blood Gas analysis under breathing air: SaO2 > 95%; COHb<3%, MetHb<2%, ctHb>10g/ dL;

排除标准：

1）筛选前3个月内每日吸烟量超过10支/d及筛选后至整个试验期间不能接受禁烟者，或者暴露于较高的一氧化碳含量环境中者；
2）合并心、肺功能疾病史者；
3）血压及心率未能控制在正常范围内者（收缩压≥140mmHg 和（或）舒张压≥90mmHg；或低血压：血压低于 90/60mmHg；心率值＜60或＞100 bpm）；
4）血小板计数＜60×10^9/L或患有凝血障碍病者；
5）近半年之内曾献过血者；
6）一个月内参加过脉搏血氧饱和度验证（有创）或三个月内参加过其他药物或医疗器项临床试验者;
7）妊娠、哺乳期女性（本试验中妊娠定义为尿妊娠试验阳性）或未来一个月内（≤30 天）有生育计划者；
8）研究者认为因其他原因不适宜参加本次临床试验者;

Exclusion criteria：

1) Those who smoked more than 10 cigarettes per day within 3 months before filtering and those could not accept smoking ban after filtering during the test period, or those were exposed to high carbon monoxide environment;
2) patients with a history of heart and lung diseases;
3) Blood pressure and heart rate cannot be controlled within the normal range (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg; Or hypotension: blood
pressure below 90/60mmHg; Heart rate < 60 or > 100 BPM);
4) Platelet count < 60×10^9/L or patients with blood coagulation disorders;
5) Those who have donated blood in the past six months;
6) Those who have participated in degree verification of pulse blood oxygen saturation (invasive) within one month or clinical trials of other drugs or medical devices within three months;
7) Pregnant or lactating women (pregnancy in this study is defined as positive urine pregnancy test) or those who have a birth plan within the next month (≤30 days);
8) Those that the investigator considers not suitable for this clinical trial for other reasons;

研究实施时间：

Study execute time：

从 From 2021-09-01 00:00:00至 To 2022-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-02-10 00:00:00 至 To 2022-03-10 00:00:00

干预措施：

Interventions：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 深圳 

市(区县)：

  

Country：

CHINA

Province：

Shenzhen

City：

单位(医院)：

 深圳大学总医院 

单位级别：

 三级甲等 

Institution
hospital：

SHENZHEN UNIVERSITY GENERAL HOSPITAL

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

脉搏血氧饱和度

指标类型：

主要指标

Outcome：

Pulse Saturation Accuracy of Pulse Oximeters

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

准确度

指标类型：

主要指标

Outcome：

Accuracy

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：

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 岁 years
最大 Max age 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）：

不适用

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

Not Applicable

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：

Blinding：

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）：

不适用

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

Not Applicable

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：

1. 采用的统计学方法 所有有效数据的统计方法是采用Excel表中的标准偏差计算，以同步的血气分析值作为参考值，待测设备的监测值作为待验证值。其中SpO2,n是第n次的待验证设备的读数值，SaO2,n 是对应的同步第n次血气分析值，另外，缺失、未用或错误，以及不合理的数据剔除需要进行说明，不参加统计计算，但是需要保留在数据记录的表格中。 统计检验采用双侧检验，P值≤0.05将被认为所检验的差别具有统计学意义。 定量指标的描述将计算均数、标准差、中位数、四分位间距、最小值、最大值。分类指标的描述将计算各类的例数及百分数。 2. 数据集 本试验的统计分析数据集确定为下列3个数据集： ①全分析集（Full analysis Set，FAS）：指尽可能接近符合ITT原则的理想的受试者人群。它应包括所有的受试者的数据。 ②符合方案集（Per Protocol Set，PPS）：全分析集的一个子集，在这个数据集中每位受试者是依从性好，不违背方案。一般是指全分析集中符合下列三个条件的病例。a.主要指标值完备；b.符合入选、排除和剔除标准。c.完全符合方案。 ③安全性数据集（Safety Set，SS）：安全性数据应包括所有入选病例至少接受一次抽血且至少有一次安全性评估的受试者。 3. 不合理数据的剔除 当出现下述情况时，对应的SpO2-SaO2数据组可视为不稳定的并应剔除： ①在血液采样的过程中，质控设备的血氧饱和度测量值变化超过2%； ②在血液采样之前的20（或30）秒，质控设备开始记录血氧饱和度，直至血液采样后5秒。这段时间内质控设备的血氧饱和度最大值和最小值之差超过3%。 数据管理由申办者及研究中心共同负责。 （1）临床试验记录应包括：血气分析仪测量显示值，受试设备测量显示值，受测对象的人数，受测对象的姓名、年龄、性别、肤色，是否符合入选要求以及在测量过程中可能影响测试结果的其他状况等； （2）血液样本将使用ABL90型血气分析仪进行分析，为排除操作者和设备的差异，每个阶梯将采2 个样本进行分析。 （3）不适合的数据排除标准 1.来自于未完成整个试验的实验对象的数据将被剔除； 2.在10秒平台读数内漂移超过4个点的数据将被剔除； 3.两次血气分析仪读数超过2个点的数据将被剔除； 4.测试过程中血氧平台不稳时记录的数据将被剔除； 5.抽血过程中有漏气现象所记录的数据将被剔除； 6.血气分析时环境不正常所记录的数据将被剔除。 （一）病例报告表填写与移交 病例报告表由研究者填写，每位入选病例必须完成病例报告表。完成的病例报告表由监查员审查后，将复印件移交数据管理员，进行数据录入与管理工作。复印件移交后，病例报告表的内容不再做修改。 （二）数据录入与修改 数据录入与管理由数据管理部负责。数据管理员采用Excel表中的标准偏差计算，进行数据录入与管理。为保证数据准确性，应由两位数据输入员独立进行双份录入并校对。 对病例报告表中存在的疑问，数据管理员将通过产生疑问解答表（DRQ）向研究人员发出询问，并通过监查员联系研究人员应尽快解答并返回；数据管理员根据研究人员的回答进行数据修改、确认与录入，必要时可以再次发出DRQ。 （三）数据锁定 在数据审核并确认建立的数据库正确后，由数据管理人员、主要研究者、统计分析人员、申办者和监查人员共同对数据进行审核，并完成分析人群的最后定义及判断，之后由数据管理员对数据进行锁定。 锁定后的数据或文件不再做改动。数据锁定之后发现的问题，经确认后在统计分析程序中进行修正。 （四）数据处理 数据库锁定后提交统计分析人员按临床试验方案要求进行统计分析。

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

1. Statistical methods The statistical method for all valid data is to calculate by the standard deviation in Excel, with the synchronous blood gas analysis value as the reference value and the monitoring value of the equipment to be tested as the value to be verified. Where, SpO2 ,and n are read values of the equipment to be verified for the NTH time, and SaO2 and n are corresponding synchronized blood gas analysis values for the NTH time. In addition, deletion of missing, unused or incorrect data and unreasonable data need to be explained, which do not participate in statistical calculation, but need to be kept in the table of data records. A two-sided test was used for statistical tests, and P ≤0.05 was considered to be statistically significant. The description of quantitative indicators will calculate mean, standard deviation, median, interquartile spacing, minimum and maximum. The description of classification indicators will calculate the number of cases and percentages for each category. 2. The data set The statistical analysis data set of this experiment was determined as the following three data sets: ① Full Analysis Set (FAS) refers to the ideal population of subjects as close as possible to the ITT principles. It should include data on all subjects. ② Per Protocol Set (PPS) : a subset of the full analysis Set, in which each subject has good compliance and does not violate the Protocol. Generally, it refers to cases in the full analysis set that meet the following three conditions. A. Complete main index values; B. Meets inclusion, exclusion and exclusion criteria. C. Full compliance with the protocol. ③ Safety Set (SS) : The Safety data should include all subjects who have received at least one blood drawing and at least one Safety assessment. 3. Elimination of unreasonable data The corresponding SPO2-SAO2 data set can be regarded as unstable and should be removed when the following conditions occur: ① In the process of blood sampling, the measured value of oxygen saturation of the quality control equipment changes by more than 2%; ② The quality control equipment begins to record the oxygen saturation 20 (or 30) seconds before the blood sample is taken and 5 seconds after the blood sample is taken. The difference between the maximum and minimum sat of the QUALITY control equipment is more than 3% during this time. Data management is the joint responsibility of the sponsor and the research center. (1) Clinical trial records should include: the values measured by the blood gas analyzer, the values measured by the test equipment, the number of subjects, the name, age, sex and skin color of subjects, whether meet the inclusion requirements and other conditions that may affect the test results during the measurement process; (2) Blood samples will be analyzed by ABL90 blood gas analyzer. In order to exclude operator and equipment differences, two samples will be taken from each step for analysis. (3) Unsuitable data exclusion criteria 1. Data from subjects which have not completed the whole experiment will be excluded; 2. Data drifting more than 4 points within a 10-second plateau reading will be removed; 3. Data with two blood gas analyzer readings of more than 2 points will be excluded; 4. Data recorded when the blood oxygen platform is unstable during the test will be removed; 5. Data recorded with air leakage during blood drawing will be excluded; 6. Data recorded in abnormal environment during blood gas analysis will be excluded. (I) Filling in and handing over the case report Form The case report form was completed by the investigator, and each selected case must complete the case report form. After the completed case report form is reviewed by the supervisor, the copy will be handed over to the data manager for data entry and management. After the copy is handed over, the content of the case report form will not be modified. (2) Data entry and modification Data entry and management are charged by the data management department. The data manager uses standard deviation calculation in Excel table for data entry and management. To ensure the accuracy of data, two data inputers should input and proofread the data independently. For the questions in the case report form, the data administrator will send questions to the researcher through the Production question Answer Form (DRQ), and contact the researcher through the supervisor to answer them and return them as soon as possible; The data manager modifies, validates and inputs the data based on the researcher's answers, and can issue the DRQ again if necessary. (3) Data locking After data review and confirmation of the correctness of the established database, data managers, main researchers, statistical analysts, sponsors and inspectors jointly review the data, and complete the final definition and judgment of the analysis group, and then data managers lock the data. Locked data or files are not changed. Problems found after data locking are confirmed and corrected in the statistical analysis procedure. 4. Data processing After the database was locked, it was submitted to the statistical analyst for statistical analysis according to the requirements of clinical trial protocol.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-02-05 10:07:06