Evaluation of Electrical Velocimetry for Assessment of Extra-vascular Lung Water in Pre-eclamptic Patients

Completed

• Conditions: Pre-Eclampsia

• Registration Number: NCT03127865
• Lead Sponsor: Cairo University

Brief Summary

The purpose of this study is to compare the sensitivity and the specificity of electrical cardiometry to the lung ultrasound in measuring thoracic lung water in pregnant females with pre-eclampsia. If electrical cardiometry is validated against ultrasound, it will be easy to use with numerical number that will not require advanced experience as with the ultrasound.

Detailed Description

Pre-eclampsia is accompanied with increased risk of serious complications such as pulmonary edema, cerebrovascular accidents, coagulopathy, and hemorrhage.

Pre-eclampsia is responsible for 46.6% of the etiology of acute pulmonary edema in pregnant women.

Fluid management in pre-eclamptic patients is challenging. Hypovolemia exacerbates organ failure, whereas volume overload results in pulmonary edema. Thus, using different methods for evaluation of volume status of the patients would improve patient management. Lung ultrasound has been developed as an accurate non-invasive method for assessment of extra-vascular lung water; However, ultrasound needs skilled operator. Electrical velocimetry (cardiometry) is a newer technology for assessment of total thoracic fluid content (TFC); however, it has not been validated in pre-eclamptic patients.

In this study the investigators will validate the accuracy of cardiometry in evaluation of lung water using the lung ultrasound as a gold standard. Both methods will be evaluated for prediction of the need of diuretic therapy and the need for post-operative oxygen therapy.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-12
• Study Start: 2017-04-18
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-25
• Status Verified: 2017-08
• Primary Completion: 2017-08-14
• Study Completion: 2017-08-16
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• pregnant
• pre-eclamptic
• In first stage of labor

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Exclusion Criteria

• Eclampsia.
• Second, third and fourth stages of labor on admission.
• Patients with severe cardiac and/or pulmonary disease.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
total thoracic fluid content	after 30 minutes from patient admission to the obstetric casuality	total fluid content measured by electrical velocimetry device (cardiometry)

Secondary Outcome Measures

Name	Time	Method
The need of diuretics	during the period starting from admission till one day after delivery	The presence of lung congestion manifested by respiratory distress (dyspnea, tachypnea, and decreased oxygen saturation below 90%) needing intravenous diuretics
extra-vascular lung water	after 30 minutes from patient admission to the obstetric casuality	extra-vascular lung water measured by ultrasound (lung ultrasound score)
lung congestion	during the period starting from admission till one day after delivery	the presence of lung congestion manifested by audible crepitations by chest auscultation
heart rate	after 30 minutes from patient admission to the obstetric casuality	the number of heart beats per minute
arterial blood pressure	after 30 minutes from patient admission to the obstetric casuality	arterial blood pressure measured in mmHg
serum albumin	after 30 minutes from patient admission to the obstetric casuality	the level of albumin in blood (measured by g/ liter

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt