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

Pre-Eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03127865
• Other study ID #: N-28-2017
• Status: Completed
• Phase: N/A
• First received: April 12, 2017
• Last updated: August 17, 2017
• Start date: April 18, 2017
• Est. completion date: August 16, 2017

Study information

• Verified date: August 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 16, 2017
• Est. primary completion date: August 14, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• pregnant

• pre-eclamptic

• In first stage of labor

Exclusion Criteria:

• Eclampsia.

• Second, third and fourth stages of labor on admission.

• Patients with severe cardiac and/or pulmonary disease.

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total thoracic fluid content	total fluid content measured by electrical velocimetry device (cardiometry)	after 30 minutes from patient admission to the obstetric casuality
Secondary	The need of diuretics	The presence of lung congestion manifested by respiratory distress (dyspnea, tachypnea, and decreased oxygen saturation below 90%) needing intravenous diuretics	during the period starting from admission till one day after delivery
Secondary	extra-vascular lung water	extra-vascular lung water measured by ultrasound (lung ultrasound score)	after 30 minutes from patient admission to the obstetric casuality
Secondary	lung congestion	the presence of lung congestion manifested by audible crepitations by chest auscultation	during the period starting from admission till one day after delivery
Secondary	serum albumin	the level of albumin in blood (measured by g/ liter	after 30 minutes from patient admission to the obstetric casuality
Secondary	arterial blood pressure	arterial blood pressure measured in mmHg	after 30 minutes from patient admission to the obstetric casuality
Secondary	heart rate	the number of heart beats per minute	after 30 minutes from patient admission to the obstetric casuality