A Multi-Center Pilot Observational Trial to Quantify the Potential Clinical Utility of Capnography in the PACU
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Frequency of Respiratory Adverse Events in the PACU identified by capnography
研究概览
简要总结
Multi-center observational trial with study device blinded in order to assess in parallel standard monitoring and intervention practices related to management of respiratory compromise in the post-anaesthesia care unit (PACU)
详细描述
All Study device information is blinded to medical staff but the Study Coordinator will have full access to device measurements, alarms, notification and events via a local Wi-Fi hub sent to a portable tablet. The tablet Case Report Form (CRF) will allow all observation be inserted with a time stamp on the electronic device data. In addition, all electronic data will be collected from the bedside monitor.
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 ≥ 18 years of age
- •ASA Score II - IV (American Society of Anaesthesiologists Score)
- •Patients booked for a surgical procedure requiring general anesthesia care
- •Expected duration of general anesthesia to be > 1.5 hours
- •Expected to receive intraoperative opioids
- •Expected to be transferred to the PACU from the operating room
- •Patients with an expected duration in the PACU ≥ 45 minutes
- •Expected to be transferred from the PACU to an in-patient setting
排除标准
- •Patients expected to be discharged from the hospital when discharged from the PACU
- •Subjects who will have oral/nasal surgery that may prevent wearing an oral/nasal capnography sampling filterline.
- •Subjects with a history of severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors.
- •Patients with skin lesions or physical deformities that would prevent the application of finger sensors for optimal performance.
- •A female known to be pregnant.
结局指标
主要结局
Frequency of Respiratory Adverse Events in the PACU identified by capnography
时间窗: Up to 2 hours in the PACU
Identification by blinded capnography to understand the ventilation challenges of patient in the PACU during standard of care that does not include capnography. First tier is RN (Registered Nurse) level of notification for early intervention and second tier is level at which covering MD (Medical Doctor) might request notification: 1. High Respiration Rate \>25 bpm for \> 15 seconds (tier one) and \>30 bpm for more than 30 seconds (tier two) 2. Low Respiration Rate \< 8 bpm for more than 15 seconds and \< 6 bpm for more than 30 seconds 3. High end tidal CO2 (EtCO2) \> 55 mmHg for \> 15 seconds and \> 60 mmHg for more than 30 seconds 4. Low EtCO2 \< 25 mmHg for \> 15 seconds and \< 25 mmHg for more than 30 seconds 5. High Heart Rate \> 120/min for 15 seconds and \>120/min for 30 seconds 6. Low Heart Rate \< 40/min for 15 seconds and \< 40/min for 30 seconds 7. SpO2 (oxygen saturation by pulse oximetry) /Hypoxemia \< 90% for more than 15 seconds and\< 90% for more than 30 seconds
次要结局
- Frequency of Critical Adverse Events (CRAE)(PACU and 24 hours post PACU)
- Ventilation insufficiency on transfer from the PACU(At PACU discharge)