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Clinical Trials/ChiCTR1800015233
ChiCTR1800015233
Not yet recruiting
Not Applicable

比较清醒和深麻醉状态下喉罩拔除对小儿呼吸道不良事件的影响：多中心、前瞻性、随机对照研究

自筹经费2 sites in 1 country240 target enrollmentStarted: April 1, 2018Last updated:
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Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
自筹经费
Enrollment
240
Locations
2
Primary Endpoint
呼吸道不良事件
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

比较小儿在不同麻醉状态下拔除喉罩对呼吸道不良事件的影响，探讨小儿麻醉期间喉罩的最佳拔除时机

Study Design

Study Type
干预性研究
Primary Purpose
随机平行对照

Eligibility Criteria

Ages
3 to 6 (—)
Sex
All

Inclusion Criteria

  • •喉罩全麻下择期行眼科手术或泌尿外科手术的患儿，年龄 3～6 岁，ASAⅠ～Ⅱ级，性别不限，麻醉持续时间至少 30 分钟

Exclusion Criteria

  • •1）患有急性上呼吸道感染的患儿；2）处于哮喘急性期或有急性支气管炎；3）患有过敏性鼻炎、过敏性皮炎等过敏性疾病的患儿；4）存在误吸风险；5）可预见的困难气道；6）颜面部解剖异常；7）听力障碍；8）患有先天性心脏病或神经系统疾病；9）睡眠呼吸暂停综合征；10）胃食管反流；11）尝试置入喉罩三次均失败需改气管插管的患儿。

Arms & Interventions

清醒拔管组

待患儿清醒后拔除喉罩

深麻醉下拔管

术毕维持 CETSev 在 1.8%，并待恢复自主呼吸（VT≥4 ml/kg，PETCO2 在 35～45 mmHg），即拔除喉罩。

Outcomes

Primary Outcomes

呼吸道不良事件

Secondary Outcomes

  • 自主呼吸恢复时间
  • 喉罩拔除时间
  • PACU 停留时间
  • 苏醒期躁动
  • 苏醒时间

Investigators

Sponsor
自筹经费

Study Sites (2)

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