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临床试验/NCT00267644
NCT00267644已完成不适用

Ultrasound of the Inferior Vena Cava (IVC) and Dehydration Status in Pediatric Emergency Patients

Antonios Likourezos1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2005年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
76
试验地点
1
主要终点
Maximum IVC Diameter

研究概览

简要总结

Objective: Although approximately 9% of patients presenting to a Pediatric Emergency Department (ED) are dehydrated, there is no reliable method to measure objectively the degree of intravascular dehydration. Respiratory changes in Inferior Vena Cava (IVC) diameter have been shown to predict volume status in adults. Previous research has demonstrated correlation between IVC diameter and volume status in children undergoing hemodialysis. Other studies have shown that IVC diameter in children can be sonographically measured rapidly and accurately by ED physicians. If we can establish that IVC diameter predicts volume status in dehydrated children, this tool could assist the ED physician in rapid diagnosis and prompt resuscitation without the need to wait for blood or urine tests. In this study we use the "dehydrated patient" as a model for hypovolemia, with the idea that the data could ultimately be used in the setting of any hypovolemic state. We aim to evaluate whether ultrasound of the pediatric IVC can be used to reliably assess volume status.

Methods: This is a prospective cohort study. Pediatric ED patients ranging in age from 1 to 41 months were assessed by a Pediatric emergency physician and stratified as either clinically euvolemic or hypovolemic. After consent was obtained, one of three Emergency Medicine Residents performed trans-abdominal sonographic measurements of the IVC diameter. Measurements of the IVC diameter just caudal to the insertion of the hepatic veins were obtained in a longitudinal orientation.

详细描述

Ultrasound is considered a routine procedure in the ED. In MMC all ultrasound done by ED staff is documented, however patients are not billed for it. All the ultrasound images for this study will have to be approved by Dr. Marshall prior to inclusion into the study.

For the purposes of this study, trans-abdominal ultrasonographic measurements of the Inferior Vena Cava (IVC) will be taken in patients suspected of being Dehydrated. The Triage Nurse will be the person who would identify acutely dehydrated patient. Once a potential candidate is identified The Attending physician in the pediatric ED will be notified. If a sonographer is available in the ED at the time and he/she is free/willing to perform the sonogram only then will the attending physician will notify and consent the patient.

The first phase of the study will concentrate on establishing the correlation between collapsed IVC and level of dehydration. During the first part of the study, ultrasonography will be performed once prior to hydration.

During this phase we will also perform sonograms on a control group. The Control Group will consist of children aged 1 month to 3 years age who we do not suspect of being dehydrated based on initial evaluation and presenting complaints.

During the second phase of the study we will measure the change in IVC diameter with fluid resuscitation. During this time, additional ultrasonography will be performed after adequate fluid resuscitation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Month 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Any patient 1-month to 36 months of age presenting to the ED with a History or vomiting, Diarrhea or decreased PO intake in which the Attending physician is concerned about Dehydration (cases) and patients in the same age group who are not suspected of dehydration (controls).

排除标准

  • a. Presentation to the ED is more than 5 days from onset of symptoms. b. Upon initial evaluation patient who are thought to need immediate resuscitation will be excluded for the study.

结局指标

主要结局

Maximum IVC Diameter

时间窗: 10 minutes

Maximum Inferior Vena Cava diameter in mm

次要结局

  • Minimum IVC Diameter(10 minutes)

研究者

发起方
Antonios Likourezos
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Antonios Likourezos

Research Manager

Maimonides Medical Center

研究点 (1)

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