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临床试验/NCT03151226
NCT03151226终止不适用

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

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2015年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
2
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

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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