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Clinical Trials/NCT05095974
NCT05095974
Unknown
Not Applicable

Echocardiography, Thoracic Fluid Content and Lung Ultrasound Monitoring as Predictors of Pulmonary Edema in Severe Preeclampsia

Assiut University0 sites58 target enrollmentOctober 30, 2021
ConditionsPulmonary Edema

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Edema
Sponsor
Assiut University
Enrollment
58
Primary Endpoint
detection of pulmonary edema
Last Updated
4 years ago

Overview

Brief Summary

Pre-eclampsia is a multisystem major cardiovascular disease of pregnancy with hypertension its main clinical manifestation. Acute pulmonary edema, which signifies severe disease, is a leading cause of death in women with pre-eclampsia, and is a frequent cause for admission to an intensive care unit

Detailed Description

Outside pregnancy, transthoracic cardiac ultrasound (echocardiography) and lung ultrasound have become important diagnostic and monitoring tools in critically ill patients. Echocardiography allows a rapid and non-invasive assessment of myocardial contractility and preload, and lung ultrasound can be used to determine the amount of extravascular lung water (EVLW). In pregnancy, there is evidence of a good correlation between non-invasive hemodynamic monitoring by echocardiography and invasive monitoring using a pulmonary artery catheter. Previous studies have shown that invasive hemodynamic monitoring could facilitate fluid management in patients with PE. However, recent studies have examined the utility of echocardiography in combination with lung ultrasound for guiding fluid therapy in patients with severe PE. Thoracic fluid content (TFC) is one of the many variables measured by the ICON electrical cardiometry (EC) device (Osypka Medical, etc.). The ICON device is one relatively new proprietary implementation of impedance cardiography technology, which is also often called "thoracic electrical bio-impedance". Impedance cardiography is based on measuring the changes in total resistance of the thorax to electric current. The impedance (Zo) to electric current is determined by the resistance of different tissues such as bone, muscles, and fluids. The fluid compartment is considered the dynamic component that will cause short term changes in thoracic impedance. TFC is calculated as the reciprocal of the total thoracic impedance (1/ Zo) and is considered a numerical measure of total (intravascular and extravascular) thoracic fluid. Although TFC is a measure of both extra and intra-vascular thoracic fluid, the investigators hypothesized that it might provide an estimate of the increase in intrathoracic fluids such as to facilitate the risk of pulmonary edema.

Registry
clinicaltrials.gov
Start Date
October 30, 2021
End Date
December 1, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yasmeen alaa-eldeen elmasry

assisstant lecturer of anesthesia and intensive care

Assiut University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Age below 18 yr
  • SP during the postpartum period
  • refusal to participate to the study.
  • history of cardiac or respiratory disease
  • patients with clinical manifestations of pulmonary edema

Outcomes

Primary Outcomes

detection of pulmonary edema

Time Frame: 4 days

number of patients that will have pulmonary edema assessed by echo comet score by lung ultrasound (the sum of B-lines if yield more than 280 denoting extravascular fluid in the lung

Secondary Outcomes

  • Echocardiography(4 days)
  • Thoracic fluid content(4 days)

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