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临床试验/NCT04367519
NCT04367519已完成不适用

Optic Nerve Sheath Diameter Versus Extra-vascular Lung Water Detected by Ultrasound in Volume Status Prediction in Severe Preeclampsia

Zagazig University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
the correlation of ONSD with EVLW

研究概览

简要总结

A quick, non-invasive, bedside test to assess fluid status of patients with severe preeclampsia would be very helpful to ICU clinicians severe preeclampsia is associated with an increase in extravascular lung water (EVLW), which can be identified by lung ultrasound before appearance of clinical signs of pulmonary edema but this technique still requires several measurements and could be time consuming.

Optic ultrasound is also a safe and repeatable diagnostic tool, which is even quicker and simpler to perform than lung ultrasound. Increased ONSD is associated with increased ICP and it can indirectly reflect the state of intracranial edema that could be a part of generalized edema.

More data on the correlation between ONSD and markers of fluid status (EVLW by ultrasound) are needed before ONSD measurements can be recommended as a guide to fluid management in preeclampsia.

详细描述

Severe preeclampsia (PE) is a progressive multisystem pregnancy disorder. It is considered the second leading cause of maternal death worldwide. Usually, it is diagnosed by the new-onset hypertension and either proteinuria or end-organ dysfunction in the second half of pregnancy.

Acute Pulmonary edema is potentially lethal and is the most common cardiopulmonary complication of preeclampsia. thus, meticulous fluid management of these patients is crucial but it is often difficult because the underlying endothelial damage leads to water, electrolytes, and plasma leakage from the intravascular space which produce significant fluid shifts into the interstitial space resulting in peripheral and/or central (pulmonary and central nervous system) edema. Also, there is a potential for hypovolemia due to the depletion of intravascular volume. Under-resuscitation of preeclampsia patients impairs organ perfusion; while on the other hand fluid overload leads to tissue edema and aggravates pulmonary edema. Therefore, fluid administration must be assessed to preserve organ perfusion, while preventing lung congestion and pulmonary edema.

Early detection of lung congestion would allow early and optimal management of these patients. Lung ultrasound was reported as a useful diagnostic tool which could identify increased levels of extravascular lung water (EVLW) in severe PE before clinical signs of pulmonary edema appear. Consequently, lung ultrasound could guide fluid management and identify those in need for diuretic therapy among severe PE patients. Though it is considered accurate, safe, and non-invasive valuable tool, its use could be limited by the need to several measurements that could be time consuming.

Changes in the Optic Nerve Sheath Diameter (ONSD) detected by ultrasound are considered an important clinical and radiographic demonstration of increased intracranial pressure (ICP) which is one of the consequences of preeclampsia. Therefore, Increased ONSD can indirectly reflect the state of intracranial edema that could be a part of generalized edema.

On ultrasound the ONSD is measured 3 mm posterior to the globe for both eyes. A position of 3 mm behind the globe is recommended because the ultrasound contrast is greatest; the results are more reproducible and the normal optic nerve sheath measures up to 5.0 mm in diameter. An average ONSD greater than 5 mm is considered abnormal and elevated intracranial pressure should be suspected.

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
21 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient acceptance.
  • Singleton Pregnant female complicated with severe preeclampsia
  • Age 18-40 years old.
  • Accepted mental state of the patient.

排除标准

  • Patient refusal to participate to the study.
  • Mild preeclampsia
  • Uncooperative patient or altered sensorium
  • Ocular wound
  • Pneumonia
  • Interstitial lung disease
  • History of prior ocular trauma or surgery
  • Preexisting heart disease
  • Known pulmonary disorders.

结局指标

主要结局

the correlation of ONSD with EVLW

时间窗: 24 hour

Ultrasound assessment was performed for all enrolled preeclampsia patients within 24 hour before delivery and at 24 hour post-delivery.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sherif M. S. Mowafy

Lecturer of anesthesia and surgical intensive care

Zagazig University

研究点 (1)

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