Evaluation of Respiratory Acoustic Monitor in Children After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 4
- 主要终点
- Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM)
研究概览
简要总结
The study will evaluate the performance of measuring respiration rate with the Respiratory Acoustic Monitoring (RAM).
详细描述
The study seeks to determine the reliability and accuracy of the acoustic respiratory monitoring (RAM) in comparison of clinically completed transthoracic impedance monitoring (TI) and manual counting of respiratory rate in postoperative pediatric patients at risk of adverse respiratory events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female children 2 to 16 years of age
- •In-patients or 23 hour short stay patients who had a tonsillectomy with a diagnosis or symptoms of obstructive sleep apnea or who had any surgery and receiving an opioid by patient controlled analgesia for post-operative pain control
- •Child weighs at least 10 kg on day of surgery
排除标准
- •Patient has skin abnormalities (rash, eczema, etc.) at the planned application sites that would interfere with sensor or electrode applications.
- •Patient is admitted to the Intensive Care Unit
- •Patient has tracheostomy
- •Patient is on non-invasive ventilator support
结局指标
主要结局
Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM)
时间窗: Up to 24 hours after surgery
The respiratory acoustic monitor records three vital signs: Respiration rate recorded in breaths per minute, oxygen saturation recorded in percentage, and heart rate recorded in beats per minute. The reliability and accuracy of the respiratory data collected by the RAM was examined by comparing to data collected clinically by the manual counting of the respiratory rate and by the respiratory rate measure by transthoracic impedance . The accuracy of RAM was examined when a staff member goes and register these measurements that occur simultaneously during the first minute of every 2 hour interval to a maximum of a 24 hour monitoring time.
次要结局
- Presence of False Alarms(Up to 24 hours after surgery)
- Tolerance of the RAM(Up to 24 hours after surgery)