Wearable Device for Prevention of Opioid-Induced Hypoxemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- AUC of SpO2 Below a Threshold of 90%
研究概览
简要总结
To evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO.
详细描述
The investigators will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. All patients will wear the Oxalert for 24 hours preoperatively in the monitoring only mode (no alerts), throughout hospitalization up to six days, and for 24 post-discharge hours. Randomization will be to Oxalert in monitor-only mode or to its normal mode which provides progressive audible and tactile alerts for hypoxemia.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults having major laparoscopic and open abdominal or pelvic surgeries;
- •Body Mass Index ≥25 kg/m2
- •American Society of Anesthesiologists physical status 1-3;
- •Age 18-85 years old;
- •Able to understand and consent to the trial and fully participate;
- •Anticipated primary opioid analgesia after surgery;
- •Expected duration of hospitalization at least 24 hours after surgery;
- •Consenting at least 24 hours before anticipated surgery.
排除标准
- •Epidural analgesia (field and fascial plane blocks permitted);
- •Pre-operative SpO2 <95%;
- •No wrist available for the study;
- •Severe hearing loss;
- •Lack of English language fluency.
- •Serious hearing deficit (unable to understand normal speech in a quite environment)
- •Serious peripheral neuropathy (unable to feel pin prick at wrist).
结局指标
主要结局
AUC of SpO2 Below a Threshold of 90%
时间窗: during hospitalization up to 6 days and post-discharge 24 hours
AUC of SpO2 Below a Threshold of 90%. SpO2 from 0% -100%.
Time-weighted Average of SpO2 Below a Threshold of 90%
时间窗: during hospitalization up to 6 days and post-discharge 24 hours
Time-weighted average of SpO2 below a threshold of 90%. Oxygen Saturation measured between 0% - 100%. Oxygen Saturation \<90% is considered abnormal.
Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min
时间窗: during hospitalization up to 6 days and post-discharge 24 hours
Duration of Desaturation Events (Saturation \<90%) Lasting at Least 2 Mi. All desaturation events were included.
Number of Participants With Desaturation Events (Saturation <90%) Lasting at Least 2 Min
时间窗: during hospitalization up to 6 days and post-discharge 24 hours
Number of Participants with Desaturation Events (Saturation \<90%) Lasting at Least 2 Min. All the patients were included.
Number of Desaturation Events (Saturation <90%) Lasting at Least 2 Min
时间窗: during hospitalization up to 6 days and post-discharge 24 hours
Number of desaturation events (Saturation \<90%) Lasting at Least 2 Mi. All desaturation events were included.
次要结局
- Nurses' Attitude Toward the Device(Post-operative day 1 (POD 1))
- Patients' Attitude Toward the Device(At the day of discharge and after 24 hours of discharge)