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临床试验/CTRI/2023/07/055069
CTRI/2023/07/055069尚未招募不适用

Comparison of Inferior Vena Cava Collapsibility Index by Point of Care USG (POCUS) and Standard Haemodynamic Monitoring as a Guide to Fluid Management in Post Spinal Hypotension - A Randomised Controlled Study

Bharati Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2023年7月21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
132
试验地点
1
主要终点
Determination of hypotension by measuring inferior vena cava collapsibility index(IVCCI) more than 40%

研究概览

简要总结

Spinal anaesthesia is one of the most commonly used methods of anaesthesia for infra umbilical procedures. . While it has advantages such as a rapid onset of action and being relatively cost effective, the most common and immediate complications are hypotension and bradycardia.

A reading of mean arterial pressure (MAP) less than 50 mmHg can be a significant cause of mortality and morbidity. Patients with inadequate volume reserve before the induction of anaesthesia are highly exposed. The identification of latent hypovolemia is therefore crucial. Inferior vena caval ultrasound (IVCUS) is effective to assess fluid responsiveness in critical care patients and has been proposed as a tool for assessing responsiveness in routine patients as well. The primary purpose of my study is to determine the efficacy of IVCCI in predicting this post spinal hypotension and managing the intra-operative fluid doses based on these values. The study will compare standard monitoring procedures i.e. Mean Arterial Pressure (MAP) with the IVCCI to determine which is more effective in predicting hypotension in these  patients. The study will assess the incidence of post spinal hypotension in the standard monitoring group (control) and USG guided measurement group (case) and compare the values obtained along with effectiveness of fluid therapy and fluid responsiveness in both groups.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Patients who are undergoing infraumbilical surgery uncder central neuraxial blockade (CNB)
  • ASA I and ASA II patients
  • Patients with good IVC visualisation.

排除标准

  • Obstetric patients
  • BMI more than 30
  • Patients with pre-existing hypovolemia
  • Patients contraindicated for central neuraxial blockade.

结局指标

主要结局

Determination of hypotension by measuring inferior vena cava collapsibility index(IVCCI) more than 40%

时间窗: Every 15 minutes for 1 hour after induction with spinal anaesthesia

次要结局

  • Comparing the number of vasopressor doses or fluid boluses provided in case & control group to manage intra operative hypotension(For 1 hour post induction with spinal anaesthesia)

研究者

发起方
Bharati Hospital and Research Centre
申办方类型
Research institution and hospital

研究点 (1)

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