Cost Effectiveness of the EndoPhys Pressure Sensing Access System vs. Radial A-line for Intra-operative Blood Pressure Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Total Cost
研究概览
简要总结
This study aims to compare the time difference between radial arterial line placement and use of the EndoPhys sheath, as well as, assess the cost effectiveness of the EnoPhys sheath vs. use of a radial arterial line based on device and operating room costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- Single (Care Provider)
盲法说明
Anesthesia team will not be made aware of the purpose of the trial.
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
- •All elective neuro endovascular procedures requiring general anesthesia and continuous invasive blood pressure monitoring
- •Adequate access to both the radial or femoral artery
排除标准
- •Pre-operative identification of contra-indication for radial arterial line placement
- •Hemodynamic instability
- •Need for continued post-operative invasive blood pressure monitoring
- •Failure to obtain informed consent
研究组 & 干预措施
EndoPhys Sheath and Radial Arterial Line
This group of patients will have both the EndoPhys sheath and the radial arterial line placed during surgery.
干预措施: EndoPhys Sheath and Radial Arterial Line (Other)
EndoPhys Sheath
This group of patients will only receive the EndoPhys sheath during surgery.
干预措施: EndoPhys Sheath (Other)
结局指标
主要结局
Total Cost
时间窗: Patient time in operating room (approximately 2 hours)
Total cost of each approach, as defined by the sum of material (device) costs plus the value of operative room time per minute.
次要结局
- Difference in preparation time between the two approaches(From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes))
- Associated anticipated costs of complications between the two groups.(Patient time in operating room (approximately 2 hours))
- Patient satisfaction as assessed by post-operative questionnaire(Questionnaire is assessed post-operatively at one day and at the 2-4 week follow up (approximately 5 minutes to assess))
- Anesthesiologist satisfaction as assessed by post-operative questionnaire(Questionnaire is assessed post-operatively in the operating room (approximately 5 minutes to assess))
- Technical success of EndoPhys sheath for blood pressure measurement and accuracy as compared to the radial arterial line.(Upon EndoPhys sheath insertion until it is removed from the femoral artery (approximately 1.5 hours))
- Sensitivity analysis to evaluated variation in times for arterial line placement(From onset of anesthesia to successful insertion of the catheter (approximately 30 minutes))
- Sensitivity analysis to evaluated variable operating room time costs(Patient time in operating room (approximately 2 hours))
- Complication rates between the two groups.(Patient time in operating room (approximately 2 hours))
研究者
Michael Froehler
Asst. Professor
Vanderbilt University Medical Center