今天是:2019-08-22 星期四

The effects of different oxygen concentrations on atelectasis after anesthesia in children undergoing ambulatory surgery
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注册号:

Registration number:

ChiCTR1900024669 

最近更新日期:

Date of Last Refreshed on:

2019-07-20 

注册时间:

Date of Registration:

2019-07-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

The effects of different oxygen concentrations on atelectasis after anesthesia in children undergoing ambulatory surgery 

Public title:

The effects of different oxygen concentrations on atelectasis after anesthesia in children undergoing ambulatory surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

The effects of different oxygen concentrations on atelectasis after anesthesia in children undergoing ambulatory surgery 

Scientific title:

The effects of different oxygen concentrations on atelectasis after anesthesia in children undergoing ambulatory 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:

茹雪 

研究负责人:

徐颖 

Applicant:

Xue Ru 

Study leader:

Ying Xu 

申请注册联系人电话:

Applicant telephone:

+86 18523367505 

研究负责人电话:

Study leader's telephone:

+86 13983409393 

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:

78003902@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

xuyingxy3066@126.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:

重庆市渝中区中山二路136号 

研究负责人通讯地址:

重庆市渝中区中山二路136号 

Applicant address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

Study leader's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

40014 

研究负责人邮政编码:

Study leader's postcode:

40014 

申请人所在单位:

重庆医科大学附属儿童医院 

Applicant's institution:

Children's Hospital of Chongqing Medical University 

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:

(2018)年伦审(研)第53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:

重庆医科大学附属儿童医院伦理委员会 

Name of the ethic committee:

Institutional Review Board of Children's Hospital of Chongqing Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-06-27 

伦理委员会联系人:

李映良 

Contact Name of the ethic committee:

Yingliang Li 

伦理委员会联系地址:

重庆医科大学附属儿童医院手术麻醉科 

Contact Address of the ethic committee:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 18523367505 

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:

重庆医科大学附属儿童医院 

Primary sponsor:

Children's Hospital of Chongqing Medical University 

研究实施负责(组长)单位地址:

重庆市渝中区中山二路136号 

Primary sponsor's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, 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):

重庆市

市(区县):

重庆市

Country:

China

Province:

Chongqing

City:

Chongqing

单位(医院):

重庆医科大学附属儿童医院

具体地址:

重庆市渝中区中山二路136号

Institution
hospital:

Children's Hospital of Chongqing Medical University

Address:

136 Second Zhongshan Road, Yuzhong District

经费或物资来源:

自筹 

Source(s) of funding:

raise independently 

研究疾病:

肺不张 

Target disease:

atelectasis 

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 

研究目的:

通过床旁超声评估吸入不同氧浓度的两组小儿术后肺不张的发生率及严重程度,以寻求更适合的吸入氧浓度,减少术后肺不张发生率,减轻肺不张的程度,提高患儿在麻醉后监测治疗室(PACU)期间的复苏质量,优化麻醉方案,提高日间手术后患儿的安全性。 

Objectives of Study:

The aim of this study was to make clear if the atelectasis occurs after anesthesia in ambulatory surgerycompare the effects of different oxygen concentrations on patients including the incidence and severity of atelectasis, as well as find out ways to reduce postoperative atelectasis , optimize the intraoperative management program, and improve security 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.ASA Ⅰ级,年龄1-12岁,手术体位为平卧位 2.我院日间短小手术,包括:疝囊高位结扎术、鞘状突高位结扎术、包块切除术等。 

Inclusion criteria

1. Children aged from 1 to 12 of year, with ASA physical status I, undergoing ambulatory surgery in supine position were included in the study; 2. The operation type included high ligation of the processus vaginalis, highligation in treatment of inguinal hernial sac ,and excision of body superficial mass. 

排除标准:

1. 术前有明显咳嗽、流涕、喷嚏等呼吸道感染症状的患儿。 2.术中SPO2降低不能维持在90%以上,需面罩加压给氧。或者术中发生其他意外事件; 3.术前合并其他系统性疾病。 

Exclusion criteria:

1. The criteria of exit and termination were the disagreement of the family, or obvious upper or lower airway infection symptoms such as cough, runny nose and sneeze; 2. desteration of pulse oxygen saturation as it cannot be maintained at more than 90%, and other abnormalities during the operation need to stop the study; 3. With systemic diseases before surgery. 

研究实施时间:

Study execute time:

From2019-08-01To 2019-09-02 

干预措施:

Interventions:

组别:

鼻导管组

样本量:

68

Group:

Nasal catheter group

Sample size:

干预措施:

术中通过鼻导管吸氧,氧流量为1L/min

干预措施代码:

Intervention:

Inhalation of 100% pure oxygen through mask with oxygen flow rate of 1L/min through nasal catherter durine surgery

Intervention code:

组别:

面罩组

样本量:

68

Group:

Mask group

Sample size:

干预措施:

通过面罩吸入100%纯氧,氧流量为5L/min

干预措施代码:

Intervention:

Inhalation of 100% pure oxygen through mask with oxygen flow rate of 5L/min durine

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆市 

市(区县):

重庆市 

Country:

China 

Province:

Chongqing 

City:

Chongqing 

单位(医院):

重庆医科大学附属儿童医院 

单位级别:

三级甲等医院 

Institution
hospital:

Children's Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

肺不张

指标类型:

主要指标 

Outcome:

rate of atelectasis

Type:

Primary indicator 

测量时间点:

测量方法:

肺部超声

Measure time point of outcome:

Measure method:

lung ultrasound examination

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 1 years
最大 Max age 12 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):

分组信息被隐藏在按顺序编号的,不透明的密封信封中,里面有对参与本试验的麻醉医生关于分组的说明。信封由训练有素的本试验研究人员打开。

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

Group allocation was concealed in sequentially numbered, opaque, sealed envelopes which was opened by trained study personnel. Each envelope contained the group allocation with instructions for the attending anesthetist.

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

重庆医科大学附属儿童医院

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

children's hospital of chongqing medical university.http://124.162.23.171:800/general/

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:

Case Record Form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-07-20
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