A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability (DIVA)
A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability to Improve Perioperative Outcome During Spinal Anaesthesia for Caesarean Section
研究概览
地位
条件
详细说明
Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and fetal adverse effects. We developed a double-vasopressor automated system incorporating continuous non-invasive haemodynamic monitoring using Nexfin cardiac output monitor with a two-step algorithm. The system delivered phenylephrine 25 mcg or ephedrine 2 mg (if heart rate<60 beats.min-1) every 30 seconds when systolic blood pressure was between 90-100% of baseline. The system delivered phenylephrine 50 mcg or ephedrine 4 mg (if heart rate<60 beats.min-1) every 30 seconds when systolic blood pressure was <90% of baseline.
A randomised controlled trial will be done to compare with manual bolus technique. With the manual bolus technique, phenylephrine 50mcg or ephedrine 4mg (if heart rate<60 beats.min-1) every 60 seconds when systolic blood pressure was between 90-100% of baseline. The system delivered phenylephrine 100mcg or ephedrine 8mg (if heart rate<60 beats.min-1) every 60 seconds when systolic blood pressure was <90% of baseline.
研究类型
注册 (实际的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
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Singapore、新加坡、229899
- KK Women's and Children's Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- age 21-45 years old,
- weight 40-90 kg,
- height 145-170 cm
Exclusion Criteria:
- contraindications to spinal anaesthesia,
- allergy to drugs used in the study, and
- those with uncontrolled medical conditions such as hypertension, diabetes mellitus, and cardiovascular disease
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:vasopressor delivery automated system
vasopressor delivery automated system administering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique
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其他名称:
其他名称:
vasopressor delivery using phenylephrine and ephedrine
其他名称:
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有源比较器:manual vasopressor delivery
manual bolus delivering phenylephrine and ephedrine using a 2 step algorithm vasopressor delivery technique
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其他名称:
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Hypotension
大体时间:1 day
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Systolic blood pressure less than 80% of baseline systolic blood pressure
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1 day
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Hypertension
大体时间:1 day
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Systolic blood pressure more than 120% of baseline systolic blood pressure
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1 day
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Nausea and vomiting
大体时间:1 day
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Nausea and vomiting during Caesarean section
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1 day
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合作者和调查者
出版物和有用的链接
一般刊物
- Du EW, Tan HS, Tan CW, Sultana R, Sng BL. Heart rate variability and haemodynamic factors associated with hypotension during spinal anaesthesia for caesarean delivery: A case-control study. Eur J Anaesthesiol. 2022 Mar 1;39(3):219-226. doi: 10.1097/EJA.0000000000001551.
- Sng BL, Du W, Lee MX, Ithnin F, Mathur D, Leong WL, Sultana R, Han NR, Sia ATH. Comparison of double intravenous vasopressor automated system using nexfin versus manual vasopressor bolus administration for maintenance of haemodynamic stability during spinal anaesthesia for caesarean delivery: A randomised double-blind controlled trial. Eur J Anaesthesiol. 2018 May;35(5):390-397. doi: 10.1097/EJA.0000000000000779.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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