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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06075407
Other study ID # 0345/2023
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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).

Study Design


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.
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