The Evaluation of a Noninvasive Respiratory Monitor in Pediatric Patients Undergoing General Anesthesia
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
- 否
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
Viviane Nasr
Anesthesiology
Boston Children's Hospital
