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临床试验/NCT05837936
NCT05837936招募中不适用

A Prospective Observational Study Evaluating Extubation Criteria in Children Less 10 Years of Age and Younger Undergoing Intravenous Anesthesia

Wake Forest University Health Sciences2 个研究点 分布在 2 个国家目标入组 600 人开始时间: 2023年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
600
试验地点
2
主要终点
Extubation success rate

研究概览

简要总结

Because Propofol is the primary "anesthetic agent," and inhalational agents remain in trace quantities at the end of the procedure Sevoflurane initiated intravenous anesthesia (SIIVA) or not present at all Total intravenous anesthesia (TIVA) it is likely that different criteria may be predictive of extubation success in these patients compared to inhalational anesthesia.

详细描述

This is because these anesthetic regimens have different pharmacologic mechanisms of actions, and therefore interact with central nervous system in different ways leading to potentially the need for different extubation criteria in patients receiving TIVA or SIIVA. Additionally, intravenous agents likely have less of an effect on airway reflexes and ventilation at light levels of anesthesia. This study is proposing an observational study to examine the predictive value of various extubation criteria in the setting of SIIVA and TIVA.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients <10 years of age
  • Undergoing elective or emergency surgery with planned airway instrumentation with an endotracheal tube (ETT)
  • Patients having general anesthesia with a planned SIIVA or TIVA technique
  • Patients with an end tidal agent concentration of Sevoflurane<0.1% at the time of emergence and extubation
  • following sevoflurane induction to place IV

排除标准

  • History of home oxygen use or ventilator dependence
  • Patients with cyanotic congenital heart disease
  • Patients undergoing anesthesia for imaging procedures alone
  • Patients intended to be managed with supraglottic airway
  • Patients having an anesthesia time < 30 minutes
  • Monitored Anesthesia Care (not general anesthesia)
  • Patients with contraindication to receiving Propofol (i.e. mitochondrial myopathy)

结局指标

主要结局

Extubation success rate

时间窗: Day 1

quality of extubation will be assess using a standard rubric for all extubation

次要结局

  • Rate of extubation that requiring intervention(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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