NCT04752904已完成不适用
Noninvasive Continuous Blood Pressure Monitoring for Preventing Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Incidence of hypotension by individualized methods
研究概览
简要总结
Noninvasive continuous blood pressure monitoring for preventing post-spinal hypotension during cesarean delivery: A randomized controlled trial
详细描述
The aim of this study was to find out whether the incidence of hypotension during surgery can be reduced in the case of non-invasive, continuous blood pressure monitoring using the ClearSight System in patients undergoing cesarean section under spinal anesthesia, compared to the case of using conventional noninvasive blood pressure monitoring
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult mothers who are pregnant with single fetuses over 35 weeks gestational age undergoing planned cesarean delivery under spinal anesthesia
排除标准
- •Multiple fetal pregnancy
- •Preexisting hypertension or pregnancy-induced hypertension
- •Underlying heart disease
- •Underlying cerebrovascular disease
- •Known fetal anomaly
- •Contraindicated in spinal anesthesia
- •Any sign of onset of labor
- •Body weight <45 kg or body weight> 90 kg
- •Height <145cm or height> 180cm
- •All other cases in which researchers determine to be inappropriate for this clinical trial
结局指标
主要结局
Incidence of hypotension by individualized methods
时间窗: From spinal anesthesia to delivery
Hypotension was defined as: SBP\<80% of baseline SBP
次要结局
- Minimum heart rate(From spinal anesthesia to delivery)
- Incidence of intraoperative severe hypotension(From spinal anesthesia to delivery)
- Number of hypotensive episodes(From spinal anesthesia to delivery)
- Incidence of intraoperative symptomatic hypotension(From spinal anesthesia to delivery)
- Time-weighted average SBP<80% of baseline SBP(From spinal anesthesia to delivery)
- Incidence of nausea, vomiting, dizziness, breathlessness(From spinal anesthesia to delivery)
- Cumulative duration of hypotension(From spinal anesthesia to delivery)
- Onset time of hypotension(From spinal anesthesia to delivery)
- Incidence of bradycardia(From spinal anesthesia to delivery)
- Apgar Score(at 1 minute after delivery and 5 minutes after delivery)
- Umbilical arterial blood(within 10 minutes after delivery)
- Umbilical arterial pH(within 10 minutes after delivery)
- Incidence of hypotension by standard methods(From spinal anesthesia to delivery)
- Time-weighted average MAP <65mmHg(From spinal anesthesia to delivery)
- Incidence of intraoperative Hypertension(From spinal anesthesia to delivery)
- Incidence of atropine use(From spinal anesthesia to delivery)
- Cardiac output, stroke volume(From spinal anesthesia to delivery)
- Maximum, Minimum recorded SBP, DBP, MBP(From spinal anesthesia to delivery)
- Cumulative consumptions of vasopressors(From spinal anesthesia to delivery)
- The analysis of the differences between the test method (ClearSight) and reference method(From spinal anesthesia to delivery)
研究者
Sun-Kyung Park
Professor
Seoul National University Hospital
研究点 (2)
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