Predictors of Pulmonary Edema in Severe Preeclampsia

• Conditions: Pulmonary Edema
• Interventions: Device: ultrasonography; Device: echocardiography; Device: thoracic electrical bioimpedence

• Registration Number: NCT05095974
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-10-15
• Last Update Submitted: 2021-10-15
• Study First Posted: 2021-10-27
• Last Update Posted: 2021-10-27
• Study Start: 2021-10-30
• Primary Completion: 2023-10-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 58

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
B (control group)	echocardiography	29 Consecutive healthy patients with a singleton pregnancy (control group) will be included in the study at hospital admission. Assessment will be done by lung ultrasound , echocardiography and thoracic bioimpedence device
B (control group)	thoracic electrical bioimpedence	29 Consecutive healthy patients with a singleton pregnancy (control group) will be included in the study at hospital admission. Assessment will be done by lung ultrasound , echocardiography and thoracic bioimpedence device
A (main group)	ultrasonography	29 Consecutive patients with a singleton pregnancy complicated by severe PE will be included in the study at hospital admission. Assessment will be done by lung ultrasound , echocardiography and thoracic bioimpedence device
A (main group)	echocardiography	29 Consecutive patients with a singleton pregnancy complicated by severe PE will be included in the study at hospital admission. Assessment will be done by lung ultrasound , echocardiography and thoracic bioimpedence device
A (main group)	thoracic electrical bioimpedence	29 Consecutive patients with a singleton pregnancy complicated by severe PE will be included in the study at hospital admission. Assessment will be done by lung ultrasound , echocardiography and thoracic bioimpedence device
B (control group)	ultrasonography	29 Consecutive healthy patients with a singleton pregnancy (control group) will be included in the study at hospital admission. Assessment will be done by lung ultrasound , echocardiography and thoracic bioimpedence device

Primary Outcome Measures

Name	Time	Method
detection of pulmonary edema	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 Outcome Measures

Name	Time	Method
Echocardiography	4 days	the increase in left ventricular end-diastolic pressures measured by (E/E' ratio, E/A ratio) and left ventricular systolic function estimated by eyeball ejection fraction
Thoracic fluid content	4 days	the increase in thoracic fluid content measured by thoracic electrical bio-impedance device