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

Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06075407
• Other study ID #: 0345/2023
• Status: Completed
• Start date: April 29, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: October 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Electrical Cardiometry
• Fluid Resuscitation
• Shock
• Transthoracic Echocardiography

Intervention

Device:
• 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).

Locations

Country	Name	City	State
Egypt	Al-Azhar University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of Electrical cardiometry (EC) to predict fluid responsiveness	Electrical cardiometry will be done be done immediately before fluid resuscitation and every 30 min till mean arterial pressure (MAP) > 65 mmHg	Intraoperative and every 30 minutes till MAP>65mmHg
Secondary	Agreement of Electrical cardiometry(EC) with Transthoracic echocardiography (TTE) in the change of stroke volume before and after fluid challenge	Fluid resuscitation will be done by intravenous infusion of lactated ringer guided by fluid responsiveness (fluid responder if SV increases by > 10% after the fluid challenge. If the patient becomes fluid non-responder, vasopressor infusion or inotrope will start.; The end of the study is when mean arterial pressure (MAP) > 65 mmHg (either by fluid or both fluid and vasopressor).	Intraoperatively.