今天是:2018年06月19日 星期二

潜在通气困难患者最佳镇静深度的快速评估和麻醉诱导方法决策

注册号:

Registration number:

ChiCTR-TRC-11001418 

注册号获得时间:

Date of releasing the registration number:

2011/07/13 

注册号状态:

预注册 

Registration Status:

Prospective registration 

注册题目:

潜在通气困难患者最佳镇静深度的快速评估和麻醉诱导方法决策 

Public title:

Rapid assessment of the optimal sedation depth and decision making in anesthesia induction in patients with potential difficult ventilation 

研究课题的正式科学名称:

潜在通气困难患者最佳镇静深度的快速评估和麻醉诱导方法决策 

Scientific title:

Rapid assessment of the optimal sedation depth and decision making in anesthesia induction in patients with potential difficult ventilation 

研究课题代号(代码):

Study subject ID:

10040210243 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

左云霞 

研究负责人:

左云霞 

Applicant:

Yunxia Zuo 

Study leader:

Yunxia Zuo 

申请注册联系人电话:

Applicant telephone:

+86 28 85423591 

研究负责人电话:

Study leader's telephone:

+86 28 85423591 

申请注册联系人传真 :

Applicant Fax:

+86 28 85423593 

研究负责人传真:

Study leader's fax:

+86 28 85423593 

申请注册联系人电子邮件:

Applicant E-mail:

zuoyunxiahxa@yahoo.com.cn 

研究负责人电子邮件:

Study leader's E-mail:

zuoyunxiahxa@yahoo.com.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):

中国成都市武侯区国学巷37号四川大学华西医院麻醉科 

申请注册联系人通讯地址:

中国成都市武侯区国学巷37号四川大学华西医院麻醉科 

研究负责人通讯地址:

中国成都市武侯区国学巷37号四川大学华西医院麻醉科 

Applicant address:

Department of Anesthesiology, West China Hospital, Sichuan University, Chendu, Sichuan Province 

Study leader's address:

Department of anesthesiology, West China Hospital , Sichuan University.Chendu, Sichuan Province, PRC 

申请注册联系人邮政编码:

Applicant postcode:

610041 

研究负责人邮政编码:

Study leader's postcode:

610041 

申请人所在单位:

中国成都市武侯区国学巷37号四川大学华西医院麻醉科 

Applicant's institution:

Department of Anesthesiology, West China Hospital, Sichuan University, Chendu, Sichuan Province 

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:

2011(3) 

伦理委员会批件附件:

Approved file of Ethical Committee:

 

批准本研究的伦理委员会名称:

四川大学华西医院伦理委员会 

Name of the ethic committee:

Ethics Committee of West China Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2011/01/13 

研究实施负责(组长)单位:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

成都市武侯区国学巷37号 

Primary sponsor's address:

No. 37, Guoxuexiang Lane, Chengdu, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

省(直辖市):

市(区县):

Country:

Province:

City:

单位(医院):

中华医学会,

具体地址:

中国北京东四西大街42号

Institution
hospital:

Chinese medical association,

Address:

No. 42, Dongsixi Street, Beijing

经费或物资来源:

中华医学会 

Source(s) of funding:

Chinese medical association clinical research grant 

研究疾病:

麻醉呼吸道失控 

Target disease:

anesthesia 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

上市后药物 

Study phase:

Post-market 

研究目的:

呼吸道失控是导致麻醉死亡的重要原因之一。其中不少灾难性事件是由于麻醉诱导阶段气管插管困难和通气困难所致。随着各种可视化插管技术的使用,目前对气管插管困难已有不少应对措施。但是,目前对直接威胁病人生命的“通气困难” 并没有很好的防治方法。术前存在上呼吸道内或者周围肿块,已经造成部分上呼吸道梗阻的病人,常规麻醉诱导在患者意识消失后可能出现上呼吸道塌陷而导致窒息缺氧。为了避免此种情况发生,如果对这类病人通通采取清醒气管插管,这势必又增加麻醉诱导的难度和病人的不舒适感。本研究拟选择低浓度七氟烷吸入的方法逐步增加镇静程度,麻醉诱导前快速评估病人在不同镇静深度下呼吸道的通畅性,并由此决策采用适合于该患者的麻醉诱导气管插管方案如清醒插管或者意识消失后气管插管。本研究的意义在于对潜在通气困难的病人科学评估后选择最佳诱导方案,避免了盲目镇静全麻诱导的风险,又减少不必要的清醒气管插管,研究结果将有助于解决“通气困难”预测与评估这一麻醉领域的重大难题,提高麻醉安全性和病人的舒适性! 

Objectives of Study:

To make a rapid assessment of airway patency by gradually deepen sedation using low-concentration sevoflurane inhalation and then making a decision for either general anesthesia induction or awake intubation for a particular patient. The aim of our study is to test the feasibility and safety by comparing it with awake intubation. The significance of this study may improve our practice in dealing with patients with potential difficulty ventilation. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

年龄18-65岁, ASA 1-3级,具备1-5条中任意一条,且自身愿意参加试验的全麻下择期手术患者: 1.气管隆突以上气道内,声门附近和口腔内肿瘤或新生物患者 2.颈部肿瘤/肿块导致气管受压患者 3.前纵隔肿瘤导致气管受压患者 4.鼾症合并睡眠呼吸暂停综合症的患者 5.颈部外伤、烧伤、手术、放疗等造成气管牵拉移位或者狭窄 6.BMI≧30合并Mallampati 评分III-IV级及甲颏间距<6.0cm的患者 

Inclusion criteria

Patients ASA I-III, aged between 18-65y, match with one of the following six criteria, undergoing elective surgery with general anesthesia will be voluntarily enrolled in this prospective study 1. Airway obstruction by Oral, oropharyngeal or hypopharygeal and trachea neoplasm or mass; 2. Airway obstruction by cervical neoplasm or mass; 3. Airway obstruction by tumor or mass in anterior mediastinum; 4. Patients with snoreing disease and Obstructive Sleep Apnea; 5. Patients with distortion or narrowing of the larynx or trachea by cervical trauma, burning, surgery and post-radiotherapy; 6. Patients with BMI≧30 and Mallampati grade III-IV and Thyroid cartilage to mentum distance <6.0cm. 

排除标准:

1.因气管内肿瘤或新生物或者气管周围包块压迫,受累横切面积达2/3以上者 2.正常情况下呼吸道梗阻导致呼吸困难已经不能平卧的患 3.合并慢支炎、肺气肿、肺炎、哮喘等呼吸道疾病患者 4.饱胃、反流性食道炎、肠梗阻等高返流误吸风险患者 5.恶性高热个人史及家族史的患者 

Exclusion criteria:

1. Normal lumenal transverse area of trachea is less than 1/3 of the original by intratracheal neoplasm, or external compression from tumor or mass around trachea; 2. Respiratory distress in the sitting position due to airway obstruction; 3. Patients complicated with respiratory diseases including pneumonia ,asthma ,chronic bronchitis ,pulmonary emphysema et al; 4. Patients with a high risk of aspiration including intestinal obstruction, full stomach ,esophageal reflux; 5. Patients with history or family history of malignant hyperthermia. 

研究实施时间:

Study execute time:

From2011-8-1To 2013-12-31 

干预措施:

Interventions:

组别:

A组

样本量:

240

Group:

Group A

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

组别:

B组

样本量:

240

Group:

Group B

Sample size:

干预措施:

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):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川大学华西医院 

单位级别:

三级甲等教学医院 

Institution
hospital:

West China Hospital 

Level of the institution:

Tertiary care medical center and teaching hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中科院北京整形医院 

单位级别:

三级甲等教学医院 

Institution
hospital:

none 

Level of the institution:

Tertiary care medical center and teaching hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京友谊医院 

单位级别:

三级甲等教学医院 

Institution
hospital:

Beijing Friendship Hospital 

Level of the institution:

Tertiary care medical center and teaching hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交大瑞金医院 

单位级别:

三级甲等教学医院 

Institution
hospital:

Ruijing Hospital 

Level of the institution:

Tertiary care medical center and teaching hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

华中科技大学协和医院 

单位级别:

三级甲等教学医院 

Institution
hospital:

none 

Level of the institution:

Tertiary care medical center and teaching hospital 

国家:

中国 

省(直辖市):

陕西 

市(区县):

 

Country:

China 

Province:

Shanxi 

City:

 

单位(医院):

第四军医大学西京医院 

单位级别:

三级甲等教学医院 

Institution
hospital:

Xijing Hospital 

Level of the institution:

Tertiary care medical center and teaching hospital 

测量指标:

Outcomes:

指标中文名:

.麻醉医师对评估过程和插管过程满意度评分

Outcome:

perception of satisfaction for induction and intubation in anesthesiologist

指标中文名:

2. 清醒成功插管率

Outcome:

successful awake intubation rate

指标中文名:

1.意识消失后成功插管率

Outcome:

successful intubation rate after lossing consciousness

指标中文名:

1.诱导期间和插管前后生命体征的变化

Outcome:

vital sign alterations during anesthesia intubation and before and after intubation

指标中文名:

4.术后咽喉部不适和声嘶发生率

Outcome:

incidence of postoperative sore throat and hoarseness

指标中文名:

3.插管失败率

Outcome:

intubation failure rate

指标中文名:

.患者对气管插管的记忆和满意度评分

Outcome:

degree of recall and perception of satisfaction in patients

指标中文名:

2.喉镜暴露时和气管插管时面部表情评分和气管插管时呛咳反应程度

Outcome:

facial expression grading scale during laryngoscope exposure and intubation , coughing and gra reac

指标中文名:

3.气管插管耗费时间

Outcome:

intubation duration

采集人体标本:

Collecting sample(s)
from participants:

未填写任何采集标本。

No sample added。

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

随机方法(请说明由何人用什么方法产生随机序列):

计算机软件

性别:

男女均可

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

computer generated

Gender:

Both

盲法:

术后随访记录者 是

Blinding:

postoperative follow-up recorder yes

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

中国成都市武侯区国学巷37号四川大学华西医院麻醉科

Data collection Institution:

Department of Anesthesiology, West China Hospital, Sichuan University, Chendu, Sichuan Province

资料管理单位:

中国成都市武侯区国学巷37号四川大学华西医院麻醉科

Data management Institution:

Department of Anesthesiology, West China Hospital, Sichuan University, Chendu, Sichuan Province

资料分析单位:

Data analysis Institution:

创建人:

Creater Name:

林静 2011/7/13 0:00:00
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