A Prospective, Observational, Double-blind (Black-Box) Study Evaluating Incidence, Severity and Predictive Factors of Respiratory Depression and Sleep Disorder Pattern During Postoperative Neuraxial Opioid Analgesia in OSA Screened Negative With BMI>=35 Kg/m2 Obstetric Patients After Cesarean Delivery Using Current Standard Intermittent Postoperative Monitoring Compared to Continuous Pulse Oximetry/Capnography
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Respiratory Depression/Suppression
研究概览
简要总结
Non emergent scheduled cesarean sections will be consented to participate in this study of patients who have screened negative for obstructive sleep apnea and who are also BMI>/= 35 to have capnography monitoring postoperatively. The capnography and pulse oximetry will be initiated in the post anesthesia care unit and be worn for 12-24 hours after delivery. Data will be retrieved after that time period in a deidentified fashion. Medication usage will be reviewed as well as the standard of care information from the duramorph monitoring will be retrieved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •OSA screen negative per hospital protocol
- •age 18 or greater
- •consent to participate to wear capnography and pulse oximetry monitoring devices post delivery
排除标准
- •Spanish speaking only
- •under age 18
- •contraindication to receiving drugs utilized in delivery anesthetic
研究组 & 干预措施
capnography monitoring
single arm, all subjects receiving duramorph will receive capnography monitoring
干预措施: Capnography monitoring (Device)
结局指标
主要结局
Respiratory Depression/Suppression
时间窗: up to 24 hours
defined by values obtained utilizing capnography and pulse oximetry
次要结局
未报告次要终点
