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Clinical Trials/NCT05236426
NCT05236426
Unknown
Not Applicable

Comparison of Cardiac Index (CI) Measurements Performed With Use of the Bioreactance Technology and Transpulmonary Thermodilution in Reference to Measurements Based on Echocardiography.

University of Warmia and Mazury in Olsztyn0 sites50 target enrollmentFebruary 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemodynamic Instability
Sponsor
University of Warmia and Mazury in Olsztyn
Enrollment
50
Primary Endpoint
Cardiac Index value measured by the transpulmonary thermodilution technique
Last Updated
4 years ago

Overview

Brief Summary

The aim of the study is to determine the correlation of the results of cardiac index (CI) measurements performed with use of bioreactance technology with the results of measurements made with the use of transpulmonary thermodilution. Both methods will be evaluated in reference to measurements based on echocardiography.

Detailed Description

After approval of the study design by the institutional ethics committee, 50 critically ill adult patients (requiring haemodynamic monitoring and mechanical ventilation) treated in the ICU for a intracranial pathology will be enrolled in the study. Exclusions: Age under 18, presence of pleural effusion or pericardium (confirmed by chest X-ray and / or ultrasound / echocardiography), presence of aortic / mitral valve disease, presence of an implanted pacemaker CI measurements will be performed simultaneously for 5 minutes. The CI value measured by the transpulmonary thermodilution technique will be obtained with the PiCCO system (Pulsiocat PV8115; Pulsion Medical Systems, Feldkirchen, Germany). Measurements will be made three times within 5 minutes. For statistical purposes, the value of the arithmetic mean of the obtained results will be used. The CI value as measured by the bioreactance method will be determined using the monitor: Starling Fluid Management System (Baxter International Inc, USA). This monitor uses bioreactance technology to determine hemodynamic parameters and bioimpedance technology to measure thoracic fluid content (TFC). The test data will be recorded with two pairs of electrodes placed on the chest according to the manufacturer's instructions. Measurements documented at 30-second intervals will concern 10 measurement cycles. The average of the obtained results will be subjected to statistical analysis. Echocardiographic examination of the heart to determine the value of CI will be performed by one (always the same) qualified (certified in echocardiographic examinations) clinician. Echocardiographic measurements will begin with determining the diameter of the left ventricular outflow tract (left ventricular outflow tract cross-sectional area, LVOT-CSA). Then, three subvalvular velocity time integral (LVOT-VTI) measurements will be made over the course of 5 minutes. This measurement will be performed in the apical five-chamber projection. The stroke volume (SV) value will be calculated as: SV = LVOT-CSA x LVOT-VTI. The CI value will be calculated using the formula: CI = SV x heart rate (HR) / body surface area (BSA). The CI value archived for further statistical analysis will be the average of three measurements performed within 5 minutes. Other variables that will be documented simultaneously with CI measurements: patient gender and weight, use of vasospastic / inotropic drugs (dose mcg / kg / min), positive end expiratory pressure (PEEP), presence of pulmonary hypertension.

Registry
clinicaltrials.gov
Start Date
February 2022
End Date
December 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Warmia and Mazury in Olsztyn
Responsible Party
Principal Investigator
Principal Investigator

Jan Adamski

Principal Investigator

University of Warmia and Mazury in Olsztyn

Eligibility Criteria

Inclusion Criteria

  • 50 critically ill adult patients (requiring haemodynamic monitoring and mechanical ventilation) treated in the ICU for a intracranial pathology

Exclusion Criteria

  • Age under 18
  • Presence of pleural effusion or pericardium (confirmed by chest X-ray and / or ultrasound / echocardiography)
  • Presence of aortic / mitral valve pathology
  • Presence of an implanted pacemaker

Outcomes

Primary Outcomes

Cardiac Index value measured by the transpulmonary thermodilution technique

Time Frame: The results of three measurements will be documented within five minutes

The cardiac index is expressed with units : Liters/minute/meter2

Cardiac index value determined with use an ultrasound technique (echocardiography)

Time Frame: The results of three measurements will be documented within five minutes

The cardiac index is expressed with units : Liters/minute/meter2

Cardiac Index value measured with use of bioreactance technology

Time Frame: The results of ten measurements at intervals of 30 seconds will be documented within five minutes

The cardiac index is expressed with units : Liters/minute/meter2

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