Use of Integrated Pulmonary Index to Predict Post-Operative Respiratory Adverse Events in High Risk Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 主要终点
- Postoperative Respiratory Event
研究概览
简要总结
The Capnostream 20p monitor by Medtronic is FDA-cleared and consists of a monitor which measures real-time respiratory status based on respiratory rate, pulse rate, pulse oximetry (SpO2) and end tidal carbon dioxide (etCO2) with a disposable nasal canula.
The integrated pulmonary index (IPI) is an algorithm driven parameter derived from non-invasive etCO2, respiratory rate, pulse rate and SpO2. Fuzzy logic is used to produce a value from 1-10 with 4 and under requiring intervention and 8-10 representing the normal range.
The purpose of this observational study is to determine if the IPI is associated with complications in the immediate postoperative period.
The study will enroll approximately 600 patients at 2 centers. Clinicians will be blinded to the IPI therefore this device will not be used to guide care in any way.
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
- •18 years or older Planned to undergo general anesthesia for surgery
排除标准
- •Pregnant Inability to consent Mechanically ventilated prior to surgery
结局指标
主要结局
Postoperative Respiratory Event
时间窗: Up to 2 hours
Respiratory complications occurring after surgery
次要结局
未报告次要终点