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

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.

Study Overview

• Status: Completed
• Conditions: Pre-Eclampsia

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pre-eclamptic patients scheduled for normal vaginal delivery or casearen section

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total thoracic fluid content	total fluid content measured by electrical velocimetry device (cardiometry)	after 30 minutes from patient admission to the obstetric casuality

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
extra-vascular lung water	extra-vascular lung water measured by ultrasound (lung ultrasound score)	after 30 minutes from patient admission to the obstetric casuality
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
serum albumin	the level of albumin in blood (measured by g/ liter	after 30 minutes from patient admission to the obstetric casuality
arterial blood pressure	arterial blood pressure measured in mmHg	after 30 minutes from patient admission to the obstetric casuality
heart rate	the number of heart beats per minute	after 30 minutes from patient admission to the obstetric casuality

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Ahmed Mukhtar, Professor, Head of research committee section in anesthesia department

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2017
• Primary Completion (Actual): August 14, 2017
• Study Completion (Actual): August 16, 2017

Study Registration Dates

• First Submitted: April 12, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 17, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: N-28-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No