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临床试验/CTRI/2026/01/100066
CTRI/2026/01/100066尚未招募4 期

To determine the predictive accuracy of subclavian vein collapsibility index for assessing intravascular volume status of patients undergoing lower limb surgeries: A prospective comparison of subclavian vein and inferior vena cava collapsibility index

Indira Gandhi Medical college1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月12日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
To calculate predictive accuracy of subclavian vein collapsibility index in non collapsing and collapsing groups of patients

研究概览

简要总结

This is a prospective study which aims to evaluate the predictive accuracy of subclavian vein collapsibility index for assessing the intravascular volume status of patients undergoing lower limb surgeries in spinal anaesthesia and compare it with inferior vena cava collapsibility index. The primary objective of the study is to calculate the sensitivity, specificity, positive predictive value and negative predictive value of subclavian vein collapsibility index for intravascular volume assessment and the secondary objective is to assess the correlation between subclavian vein collapsibility index and inferior vena cava collapsibility index. Therefore the study seeks to establish whether subclavian vein collapsibility index is feasible and reliable alternative to inferior vena cava collapsibility index particularly in situations where inferior vena cava visualisation is difficult.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing lower limb orthopaedic surgeries in spinal anaesthesia Patients in age group of 18 to 60 years weighing 50 to 80 kg with BMI less than 35 kg per meter square Mean arterial pressure more than 65mmHg ASA 1 and 2 physical status patients.

排除标准

  • Refusal to participate Patients requiring vasopressors to maintain arterial blood pressure greater than 65mmHg Cardiac disease Implanted pacemaker Morbid obesity Respiratory distress Autonomic nervous system disorders Presence of major peripheral vascular disease Portal hypertension Pregnancy.

结局指标

主要结局

To calculate predictive accuracy of subclavian vein collapsibility index in non collapsing and collapsing groups of patients

时间窗: Assessment in non collapsing group at baseline and assessment in collapsing group at baseline and 15 minutes post fluid bolus.

次要结局

  • To calculate predictive accuracy of subclavian vein collapsibility index in collapsing group of patient after receiving a fluid bolus of 500ml(15 minutes)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Aparna Sharma

Indira Gandhi Medical college, Shimla, Himachal Pradesh

研究点 (1)

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