Blinded Observational Study to Evaluate a Non-Invasive Respiratory Volume Monitor in the Post-Anesthesia Care Unit and on the General Hospital Floor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Low minute ventilation
研究概览
简要总结
This observational study investigates the validity and utility of a new, non-significant risk, FDA approved respiratory monitor, ExSpiron, in the perioperative course of patients undergoing elective surgery under general anesthesia. The study patients will be monitored before, during and after surgery, in post-anaesthesia care unit (PACU) and recovery room for the first post-operative night. The physiologic data will not be used or influence the standard of care for subjects. It is anticipated that this monitor may be able to improve perioperative care in the future.
详细描述
Aim and Hypotheses Currently, there is no objective measure of early respiratory indicators for developing respiratory compromise in surgical patients. Current respiratory assessment in non-intubated patients relies on oximetry data 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 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) in general patient population.
Hypotheses
Primary:
Low minute ventilation (LMV) defined as sustained LMV<40% minute ventilation predicted (MVPRED) based on IBW following opioid administration correlates with adverse clinical outcomes in PACU or on the floor including:
- O2 desaturation, atelectasis, respiratory status requiring advanced monitoring
- respiratory interventions such as O2 administration, continuous positive airway pressure CPAP, BiPAP,
- incidence of ICU transfer and/or increase in PACU and/or general hospital floor (GHF) length of stay (LOS).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients undergoing surgery with general anesthesia and positive pressure ventilation, patient's ≥80 pounds and who are able to give informed consent.
排除标准
- •Patients unable to give informed consent. Any patient whose condition or procedure will not allow for placement of the electrode PadSet
结局指标
主要结局
Low minute ventilation
时间窗: Post-operatively in PACU and general patient' floor up to 24 hours after completion of surgery
Low minute ventilation (LMV) defined as sustained LMV\<40% minute ventilation predicted (MVPRED) based on IBW following opioid administration correlates with adverse clinical outcomes in PACU and on the floor
次要结局
未报告次要终点