Oscillometric Versus Intraarterial Blood Pressure Monitoring to Reduce Intraoperative Hypotension During Robot-Assisted Prostatectomy: A Non-Inferiority Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Time-weighted average MAP <65 mmHg
研究概览
简要总结
The PROST-BP trial is a prospective, single-center, randomized, patient-blinded, non-inferiority trial investigating whether intermittent oscillometric blood pressure monitoring is non-inferior to continuous intraarterial blood pressure monitoring in reducing intraoperative hypotension in patients having robot-assisted radical prostatectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •male patient ≥18 years
- •scheduled for elective robot-assisted (Da Vinci) radical prostatectomy in steep Trendelenburg position
- •planned intraarterial blood pressure monitoring
排除标准
- •patients in whom the attending anesthesiologist considers intraarterial blood pressure monitoring to be mandatory for clinical reasons
- •patients participating in another interventional trial likely to influence intraoperative blood pressure management
研究组 & 干预措施
Intraarterial blood pressure monitoring
Intraoperative blood pressure will be managed based on intraarterial blood pressure monitoring.
干预措施: Intraarterial blood pressure monitoring (Other)
Oscillometric blood pressure monitoring
Intraoperative blood pressure will be managed based on oscillometric blood pressure monitoring.
干预措施: Oscillometric blood pressure monitoring (Other)
结局指标
主要结局
Time-weighted average MAP <65 mmHg
时间窗: From the start of surgery until the end of surgery
Time-weighted average MAP \<65 mmHg \[mmHg\], calculated from the start of surgery until the end of surgery (continuous endpoint)
次要结局
- Area under a MAP <65 mmHg(From the start of surgery until the end of surgery)
- Total duration of MAP <65 mmHg(From the start of surgery until the end of surgery)
- Number of discrete hypotensive episodes(From the start of surgery until the end of surgery)
- Area above a MAP >100 mmHg(From the start of surgery until the end of surgery)
- Time-weighted average MAP >100 mmHg(From the start of surgery until the end of surgery)
- Average norepinephrine infusion rate(From the start of surgery until the end of surgery)
- Total volume of administered crystalloids(From the start of surgery until the end of surgery)
研究者
Dr. Alina Bergholz
Principal Investigator
University of Hamburg-Eppendorf