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临床试验/NCT05594030
NCT05594030尚未招募不适用

Thoracic Fluid Content by Electric Bioimpedance Versus Lung Ultrasound in Preterm Neonates With Respiratory Distress

Ain Shams University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
试验地点
2
主要终点
predictive value of thoracic fluid content measurement for detecting the need for surfactant administration or positive pressure ventilation requirement in preterm neonates with respiratory distress and to compare it to lung ultrasound.

研究概览

简要总结

A prospective cohort study aims to evaluate the predictive value of thoracic fluid content measured by electric bioimpedance for detecting the need for surfactant administration or positive pressure ventilation requirement; whether invasive or non-invasive; in preterm neonates with respiratory distress and to compare it to lung ultrasound.

详细描述

Electrical cardiometry (bioimpedance) is an impedance-based method that has been recently introduced for continuous noninvasive hemodynamic monitoring for cardiac output (CO) and TFC in both term and preterm infants.

TFC is the sum of the total fluid volume found in the chest cavity; it is measured as the baseline resistance (bioimpedance) to the passage of a small electrical current through all chest tissues.

Larger TFC indicates a higher total thoracic fluid volume. TFC measurement has been correlated with heart failure symptoms, net fluid balance, and chest radiographic findings of abnormal pulmonary fluid content in adults.

Lung ultrasound (LUS) is a reliable technique for physicians to complement physical examination findings and has emerged as an alternative option to overcome the limitations of chest x rays (CXRs). Moreover, LUS shows better diagnostic accuracy than CXR in some critical conditions and has been successfully adapted in NICUs for the diagnosis of several diseases.

We thought that TFC monitoring may be able to predict the need for surfactant administration or positive pressure ventilation requirement; whether invasive or non-invasive; in preterm neonates with respiratory distress comparable to LUS.

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 Minute 至 3 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm neonates with gestational age ≤ 34 weeks, admitted with respiratory distress:
  • Defined as the presence of at least two of the following clinical symptoms:
  • Tachypnea, grunting, retractions (subcostal, intercostal, suprasternal), nasal flaring and other symptoms include apnea, bradypnea, irregular (seesaw) breathing, inspiratory stridor, wheezes and hypoxia

排除标准

  • Preterm neonates with evidence of any of the following:
  • Chromosomal anomalies Mechanical ventilation or received endotracheal surfactant before first assessment

结局指标

主要结局

predictive value of thoracic fluid content measurement for detecting the need for surfactant administration or positive pressure ventilation requirement in preterm neonates with respiratory distress and to compare it to lung ultrasound.

时间窗: 72 hours

Thoracic fluid content will be measured on enrolment (TFC10 and follow up will be done after 3 days (TFC2) and at extubation from mechanical ventilation (TFC3) by electrical bioimpedance

次要结局

  • TFC parameters may offer the ability to monitor lung fluid content and provide longitudinal follow-up during interventions and disease processes.(72 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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