Predictors of Pulmonary Edema in Severe Preeclampsia

NCT ID: NCT05095974

Last Updated: 2021-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 58 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-30
• Study Completion Date: 2023-12-01

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.

Conditions

Pulmonary Edema

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

A (main group)

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

ultrasonography

Intervention Type: DEVICE

Ultrasound assessment will performed with parturient in the supine position using Mindray device (DC-N6, with a phased array transducer, model P4-2, 3-6 MHz). A C60x 5-2 MHz convex transducer will used for lung ultrasound (Mindray device (DC-N6, with a phased array transducer, model P4-2, 3-6 MHz).The Echo Comet Score (ECS) will obtained by the 28-rib interspaces technique dividing the chest wall in 12 areas on the left side (from the second to the fourth intercostal space) and 16 (from the second to the fifth intercostal space) on the right anterior and lateral hemithorax.

echocardiography

Intervention Type: DEVICE

MHz cardiac transducer for echocardiography with two-dimensional, M-mode, color-flow, continuous, pulsed wave and tissue Doppler imaging.

thoracic electrical bioimpedence

Intervention Type: DEVICE

EC ICONR monitor (Osypka Medical, Inc., La Jolla, California and Berlin) will be applied to the patients through four ECG electrodes. The electrodes will be placed over the bare skin of patients at the following sites: (1) on the left neck below the ear; (2) directly superior to the midpoint of the left clavicle; (3) along the left mid-axillary line at the level of the xiphoid process; (4) two-inches caudad from the third electrode.

B (control group)

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

ultrasonography

Intervention Type: DEVICE

Ultrasound assessment will performed with parturient in the supine position using Mindray device (DC-N6, with a phased array transducer, model P4-2, 3-6 MHz). A C60x 5-2 MHz convex transducer will used for lung ultrasound (Mindray device (DC-N6, with a phased array transducer, model P4-2, 3-6 MHz).The Echo Comet Score (ECS) will obtained by the 28-rib interspaces technique dividing the chest wall in 12 areas on the left side (from the second to the fourth intercostal space) and 16 (from the second to the fifth intercostal space) on the right anterior and lateral hemithorax.

echocardiography

Intervention Type: DEVICE

MHz cardiac transducer for echocardiography with two-dimensional, M-mode, color-flow, continuous, pulsed wave and tissue Doppler imaging.

thoracic electrical bioimpedence

Intervention Type: DEVICE

EC ICONR monitor (Osypka Medical, Inc., La Jolla, California and Berlin) will be applied to the patients through four ECG electrodes. The electrodes will be placed over the bare skin of patients at the following sites: (1) on the left neck below the ear; (2) directly superior to the midpoint of the left clavicle; (3) along the left mid-axillary line at the level of the xiphoid process; (4) two-inches caudad from the third electrode.

Interventions

ultrasonography

Ultrasound assessment will performed with parturient in the supine position using Mindray device (DC-N6, with a phased array transducer, model P4-2, 3-6 MHz). A C60x 5-2 MHz convex transducer will used for lung ultrasound (Mindray device (DC-N6, with a phased array transducer, model P4-2, 3-6 MHz).The Echo Comet Score (ECS) will obtained by the 28-rib interspaces technique dividing the chest wall in 12 areas on the left side (from the second to the fourth intercostal space) and 16 (from the second to the fifth intercostal space) on the right anterior and lateral hemithorax.

Intervention Type: DEVICE

echocardiography

MHz cardiac transducer for echocardiography with two-dimensional, M-mode, color-flow, continuous, pulsed wave and tissue Doppler imaging.

Intervention Type: DEVICE

thoracic electrical bioimpedence

EC ICONR monitor (Osypka Medical, Inc., La Jolla, California and Berlin) will be applied to the patients through four ECG electrodes. The electrodes will be placed over the bare skin of patients at the following sites: (1) on the left neck below the ear; (2) directly superior to the midpoint of the left clavicle; (3) along the left mid-axillary line at the level of the xiphoid process; (4) two-inches caudad from the third electrode.

Intervention Type: DEVICE

Other Intervention Names

electrical cardiometry

Eligibility Criteria

Inclusion Criteria

Pregnant women with one or more of the following:

• new-onset cerebral or visual disturbances
• thrombocytopenia (platelet count <100 000/mL)
• elevated liver enzymes (transaminases) to twice the normal upper limit;
• severe persistent pain in the right upper or middle upper abdomen that does not respond to medication and is not explained by another condition
• renal insufficiency (serum creatinine >97 μmol/L), or a doubling of serum creatinine concentration in the absence of other renal disease
• systolic blood pressure ≥160mmHg or diastolic blood pressure ≥110mmHg on more than one occasion at least 4 h apart while the patient is on bed rest (unless antihypertensive therapy had been initiated before this time).

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Yasmeen alaa-eldeen elmasry

assisstant lecturer of anesthesia and intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

pulmonary edema

Identifier Type: -

Identifier Source: org_study_id