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NCT Number: NCT03127865

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.

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Key information

Conditions

Pre-eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. total thoracic fluid content

    Time frame: after 30 minutes from patient admission to the obstetric casuality

    total fluid content measured by electrical velocimetry device (cardiometry)

Secondary outcomes

  1. The need of diuretics

    Time frame: 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

  2. extra-vascular lung water

    Time frame: after 30 minutes from patient admission to the obstetric casuality

    extra-vascular lung water measured by ultrasound (lung ultrasound score)

  3. lung congestion

    Time frame: during the period starting from admission till one day after delivery

    the presence of lung congestion manifested by audible crepitations by chest auscultation

  4. serum albumin

    Time frame: after 30 minutes from patient admission to the obstetric casuality

    the level of albumin in blood (measured by g/ liter

  5. arterial blood pressure

    Time frame: after 30 minutes from patient admission to the obstetric casuality

    arterial blood pressure measured in mmHg

  6. heart rate

    Time frame: after 30 minutes from patient admission to the obstetric casuality

    the number of heart beats per minute

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 25, 2017
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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