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临床试验/CTRI/2022/01/039217
CTRI/2022/01/039217尚未招募不适用

ASSESSMENT OF FLOW-BASED DYNAMIC INDICES TO PREDICT FLUID RESPONSIVENESS IN NEONATES

Department of Anaesthesia and Intensive Care1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2022年1月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
Respiratory variations in peak velocity of aortic blood flow

研究概览

简要总结

Administration of intravenous fluid boluses is a common intervention to treat perioperative hypotension. But, fluid administration may not always correct hypotension. Excessive intravenous fluid has many adverse affects. In quest of objective parameters to predict fluid responsiveness, static parameters like heart rate, blood pressure, central venous pressure and others failed to serve this purpose. Dynamic parameters, which are based on heart lung interaction are found to be useful in predicting fluid responsiveness in adults. Neonates physiology is different from adult population. So, we plan to conduct a study to validate the dynamic parameters viz. respiratory variation in aortic outflow, respiratory variation in velocity time integral of aortic flow  and plethysmography variability index to predict fluid responsiveness in neonates undergoing procedures under general anaesthesia.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • Late preterm (>34 weeks of gestational age) and term neonates upto 28 days of age scheduled for elective or emergency non-thoracic and non-cardiac surgeries.

排除标准

  • Congenital heart disease Cardiac arrhythmias Neonates on inotropic and/ or vasoactive support Pneumonia/ Atelectasis Denial to participate in the study.

结局指标

主要结局

Respiratory variations in peak velocity of aortic blood flow

时间窗: 1. Baseline immediately after induction of anaesthesia. As a standard of care, an i.v. bolus of 10 ml/kg Ringers Lactate will be administered over 10 minutes after taking baseline measurement. | 2. Second measurement will be done 2 minutes after end of i.v. fluid bolus

次要结局

  • Respiratory variations in velocity time integral of aortic blood flow and plethysmographic variablility index(1. Baseline immediately after induction of anaesthesia. As a standard of care, an i.v. bolus of 10 ml/kg Ringers Lactate will be administered over 10 minutes after baseline measurements.)

研究者

发起方
Department of Anaesthesia and Intensive Care
申办方类型
Research institution and hospital

研究点 (1)

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