NCT01881269已完成不适用
Assessment of Respiration Rate Monitoring During Transitions From Spontaneous to Controlled Ventilation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Time to report a Respiration Rate value after initiation of controlled ventilation
研究概览
简要总结
The purpose of this study is to evaluate the performance of the software that calculates respiration rate for the study pulse oximetry monitoring system during transitions of ventilation type from spontaneous breathing to controlled ventilation.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be undergoing a procedure with planned general anesthesia involving placement of an endotracheal tube or laryngeal mask airway following induction of anesthesia.
- •American Society of Anesthesiologists physical status classification (ASA) Status 1, 2 or
- •Body mass index (BMI) ≤30 kg/m
- •Subject is willing and able to provide written consent.
排除标准
- •Female subjects of child-bearing potential with a positive pregnancy test or an absence of documented non-childbearing status in the medical history records.
- •Female subjects who are currently lactating and breastfeeding.
- •Subjects with any evidence of potential difficulty in mask ventilation and/or tracheal intubation.
- •Subject has an abnormality that may prevent proper application of the device/sensors.
- •Subject is in atrial fibrillation.
- •Subject has a documented history of frequent premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds.
- •Subject has an implanted pacemaker.
- •Subjects with non-sinus rhythm, frequent premature ventricular complexes (> 5 min), or abnormal PR, QRS, or QT intervals on screening ECG.
- •Subjects with artificial finger nails.
结局指标
主要结局
Time to report a Respiration Rate value after initiation of controlled ventilation
时间窗: 1 - 3 minutes after the initiation of controlled ventilation
Time (in seconds) for the software to report a Respiration Rate value within one breath per minute of the controlled ventilation rate after placement of the airway device (endotracheal tube or laryngeal mask airway)
次要结局
未报告次要终点
研究者
研究点 (1)
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