Evaluation of Fluid Resuscitation in Shocked Patients by Electrical Cardiometry in Comparison to Transthoracic Echocardiography.

NCT ID: NCT06075407

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-29
• Study Completion Date: 2023-09-01

Brief Summary

The aim of this study is to evaluate the diagnostic accuracy of electrical cardiometry (EC) for the noninvasive determination of fluid responsiveness in critically ill shocked patients and agreement of EC compared to transthoracic echocardiography (TTE)

Detailed Description

Electrical cardiometry (EC), based on thoracic electrical bioimpedance, can measure SV continuously and non-invasively. The EC"s working principle of estimation of SV is to utilize changes in thoracic electrical impedance, which is mainly influenced by erythrocyte orientation and peak flow velocity in the ascending aorta throughout the cardiac cycle.

Electrical cardiometry (EC) has been validated to monitor SV and other hemodynamic parameters non-invasively compared to different techniques such as thermodilution technique, transesophageal Doppler echocardiography and cardiac catheterization including critically ill patients, intra-operative settings, in pregnant women, in children with congenital heart diseases, even in obese children

Conditions

Fluid Resuscitation; Electrical Cardiometry; Transthoracic Echocardiography; Shock

Study Design

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

Study Groups

Fluid responder

All patients will undergo a volume expansion test or fluid challenge according to standard protocol. The volume expansion test will be performed with an intravenous infusion of 0.9% sodium chloride (500mL) within 15 minutes. The patient becomes a fluid responder if SV increases by \> 10% after the fluid challenge.

Assessment of fluid responsiveness by electrical cardiometry

Intervention Type: DEVICE

Electrical cardiometry (EC) measurements: by the ICON_ hemodynamic monitor (ICON Cardiotropic, Inc., La Jolla, CA 92307; Osyka Medical GmbH, Berlin, and Germany, model C3).

Transthoracic echocardiography (TTE) measurements will be performed equipped with echo probe. SV of the left ventricle will be calculated using LVOT diameter (D) just below the aortic valve from parasternal long-axis view and VTI measured in LVOT from apical 5 chamber view (by pulsed wave Doppler).

Fluid non-responder

All patients will undergo a volume expansion test or fluid challenge according to standard protocol. The volume expansion test will be performed with an intravenous infusion of 0.9% sodium chloride (500mL) within 15 minutes. The patient becomes a fluid responder if SV increases by \> 10% after the fluid challenge (21). If the patient becomes a fluid non-responder, vasopressor infusion or inotrope will start.

Assessment of fluid responsiveness by electrical cardiometry

Intervention Type: DEVICE

Electrical cardiometry (EC) measurements: by the ICON_ hemodynamic monitor (ICON Cardiotropic, Inc., La Jolla, CA 92307; Osyka Medical GmbH, Berlin, and Germany, model C3).

Transthoracic echocardiography (TTE) measurements will be performed equipped with echo probe. SV of the left ventricle will be calculated using LVOT diameter (D) just below the aortic valve from parasternal long-axis view and VTI measured in LVOT from apical 5 chamber view (by pulsed wave Doppler).

Interventions

Assessment of fluid responsiveness by electrical cardiometry

Electrical cardiometry (EC) measurements: by the ICON_ hemodynamic monitor (ICON Cardiotropic, Inc., La Jolla, CA 92307; Osyka Medical GmbH, Berlin, and Germany, model C3).

Transthoracic echocardiography (TTE) measurements will be performed equipped with echo probe. SV of the left ventricle will be calculated using LVOT diameter (D) just below the aortic valve from parasternal long-axis view and VTI measured in LVOT from apical 5 chamber view (by pulsed wave Doppler).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age from 25 to 65 years old.
• Both sexes.
• Patients with clinical criteria of shock [mean arterial pressure (MAP) ≤ 65 mmHg and tissue hypoperfusion (ScvO2 <70%, P(cv-a) CO2 ≥6 mmHg, CRT ≥4 s and lactate >2mmol/l).

Exclusion Criteria

• Refusal to sign the consent by a first degree relative.
• Previous cardiac disease, rhythm other than sinus rhythm or heart rate > 140 beat/min.
• Renal failure (acute or chronic).

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdel Aziz Abdel Raouf

Specialist of Anesthesiology, Surgical Intensive Care and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Al-Azhar University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

0345/2023

Identifier Type: -

Identifier Source: org_study_id