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临床试验/NCT02336022
NCT02336022已完成不适用

The Evaluation of a Noninvasive Respiratory Monitor in Pediatric Patients Undergoing General Anesthesia

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Minute ventilation accurately measured by the ExSpiron monitor during controlled ventilation.

研究概览

简要总结

Pediatric postoperative patients are at increased risk for post-operative respiratory complications such as hypoventilation. There is no objective measure of early respiratory parameters that would predict respiratory compromise after surgery efficiently in pediatric patients. Current respiratory assessment in non-intubated patients relies on oximetry data, impendence respiratory rate monitor and subjective clinical assessment. Pulse oximetry has been extremely helpful in recognizing oxygen desaturations but it is a late indicator of respiratory decline. New advances in technology and digital signal processing have led to the development of an improved impedance based Respiratory Volume Monitor (RVM). The RVM (ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) has been shown to provide accurate real-time, continuous, non-invasive measurements of tidal volume (TV), minute ventilation (MV) and respiratory rate (RR) mostly in adult patients. The investigators' primary hypothesis is that the non-invasive, impedance-based RVM monitor will accurately reflect TV, RR and MV in pediatric patients.

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
1 Year 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • pediatric patients between the ages of 1 year and 17 years
  • ASA status of 1-3
  • scheduled to undergo a procedure with general anesthesia at Boston Children's Hospital

排除标准

  • Patients undergoing an emergency procedure or a
  • patients undergoing a procedure where the study monitor will interfere with the surgical procedure site or standard of care
  • preexisting respiratory disease
  • muscular disease affecting the respiratory system

结局指标

主要结局

Minute ventilation accurately measured by the ExSpiron monitor during controlled ventilation.

时间窗: intraoperative

Respiratory rate accurately measured by the ExSpiron monitor during controlled ventilation.

时间窗: intraoperative

Tidal Volume accurately measured by the ExSpiron monitor during controlled ventilation.

时间窗: intraoperative

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Viviane Nasr

Anesthesiology

Boston Children's Hospital

研究点 (1)

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