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临床试验/NCT04155892
NCT04155892已完成不适用

A Prospective Observational Study Evaluating Extubation Criteria in Children Less Than 8 Years of Age With Upper Respiratory Infection Undergoing Outpatient or Day Hospital Based Surgery

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 760 人开始时间: 2019年12月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
760
试验地点
1
主要终点
Rate of participants with a successful extubation

研究概览

简要总结

The investigators are currently completing a data collection to try to optimize pediatric patients' preoperative screening, in the setting of an upper respiratory infection.

详细描述

The objectives of this study are to evaluate various extubation criteria and their predictive value for successful extubation in non-cardiac surgical procedures. To evaluate the predictive value of room air oxygen and an original preoperative URI questionnaire in pediatric patients with URI or URI symptoms.

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 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All study participants must be undergoing general anesthesia and surgery with an endotracheal tube
  • The URI group will be participants with a score of at least 3 on our pre-operative URI survey, with planned airway instrumentation with an endotracheal tube (ETT) for their surgical procedure who are to be discharged same day or on postoperative day
  • The non URI group will be participants undergoing elective procedures with no URI symptom or recent URI. Defined as no URI or "allergy" symptom within the past 6 weeks and a score of 1 or less on the URI survey, with planned airway instrumentation with an ETT for their surgical procedure who are to be discharged same day or on postoperative day 1.

排除标准

  • History of home oxygen use or ventilator dependence,
  • Patients undergoing emergent procedures.
  • Patients with cyanotic congenital heart disease.
  • Patients receiving a surgical procedure where the duration of post procedure
  • admission is anticipated to be greater or equal to 2 postoperative days.
  • Patients undergoing anesthesia for imaging procedures alone.
  • Patients who are extubated deep intentionally.
  • Patients intended to be managed with supraglottic airway.
  • Patients undergoing total IV anaesthesia (TIVA).

研究组 & 干预措施

URI group

This group includes participants <8 years of age undergoing elective procedures with a score of at least 3 on our pre-operative URI survey.

non-URI group

This group includes participants <8 years of age undergoing elective procedures with no URI symptoms or recent URI.

结局指标

主要结局

Rate of participants with a successful extubation

时间窗: Day 1

The quality of extubation will be graded as successful, intervention required or major intervention required

The rate of successful extubation in children with at least 3 of the five criteria present

时间窗: Day 1

The 5 criteria (facial grimace, eye opening, conjugate gaze, purposeful movement, and tidal volume \> 5 cc/kg)

Rate of participants with an extubation requiring intervention

时间窗: Day 1

The quality of extubation will be graded as successful, intervention required or major intervention required

Rate of participants with an extubation requiring major intervention

时间窗: Day 1

The quality of extubation will be graded as successful, intervention required or major intervention required

次要结局

  • Rate of on time and anticipated discharge from the hospital(Up to 5 days after discharge)
  • Rate of patients seeking additional care following discharge for respiratory related symptoms(Up to 5 days after discharge)
  • Preoperative room air oxygen saturation(Day 1)
  • Rate of extubation success per the number of factors present at time of extubation(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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