Clinical trial NCT05236426: Comparison of Cardiac Index (CI) Measurements Performed With Different Methods
Official title: Comparison of Cardiac Index (CI) Measurements Performed With Use of the Bioreactance Technology and Transpulmonary Thermodilution in Reference to Measurements Based on Echocardiography.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemodynamic Instability
Keywords: hemodynamic monitoring
cardiovascular monitoring
bioreactance
echocardiography
pulmonary thermodilution
Lead sponsor: University of Warmia and Mazury in Olsztyn
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 critically ill adult patients (requiring haemodynamic monitoring and mechanical ventilation) treated in the ICU for intracranial pathology

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.

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

Primary outcomes:
measure: Cardiac Index value measured by the transpulmonary thermodilution technique
timeFrame: The results of three measurements will be documented within five minutes
measure: Cardiac Index value measured with use of bioreactance technology
timeFrame: The results of ten measurements at intervals of 30 seconds will be documented within five minutes
measure: Cardiac index value determined with use an ultrasound technique (echocardiography)
timeFrame: The results of three measurements will be documented within five minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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