Comparison of the Ultrasonic Cardiac Output Monitor and Echocardiography for Hemodynamic Assessment in Pediatric Anesthesia

NCT07342842 | Completed

• 1 other identifier: USCOM-Echo
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational pilot study evaluates agreement between Ultrasound Cardiac Output Monitor (USCOM) measurements and transthoracic echocardiography-derived hemodynamic parameters in pediatric patients under standardized general anesthesia prior to surgical incision. Under stable hemodynamic and ventilatory conditions, suprasternal Doppler-derived velocity time integral (VTI), stroke volume (SV), cardiac output (CO), stroke volume variation (SVV), and aortic valve area (AVA) are obtained sequentially with USCOM and echocardiography within a short time window without changes in ventilation, anesthetic depth, positioning, fluid therapy, or vasoactive support. Agreement is assessed using correlation and Bland-Altman analyses.

Conditions

USCOM; Echocardiography; Echocardiography Guided Fluid Management

Outcome Measures

Primary Outcomes (1)

• Agreement Between USCOM and Echocardiography for Stroke Volume and Cardiac Output

  Agreement of paired SV and CO values obtained by USCOM and echocardiography under stable conditions, evaluated using Bland-Altman analysis (bias and 95% limits of agreement) and correlation.

  Intraoperative, after induction and stabilization and before surgical incision (single assessment; within 1-2 minutes between methods).

Secondary Outcomes (4)

• Correlation Between USCOM VTI and Echocardiography VTI (Suprasternal Doppler)

  Single intraoperative assessment after induction and stabilization and before surgical incision (measurements obtained sequentially within 1-2 minutes).

• Agreement Between USCOM and Echocardiography for Stroke Volume Variation

  Single intraoperative assessment after induction and stabilization and before surgical incision (measurements obtained sequentially within 1-2 minutes).

• Comparison of Device-Calculated Versus Echocardiography-Derived Aortic Valve Area

  Single intraoperative assessment after induction and stabilization and before surgical incision (measurements obtained sequentially within 1-2 minutes).

• Bland-Altman Agreement of Paired Hemodynamic Variables

  Single intraoperative assessment after induction and stabilization and before surgical incision (measurements obtained sequentially within 1-2 minutes).

Interventions

USCOM OTHER

Ultrasound cardiac output monitoring is performed using a suprasternal approach to obtain spectral Doppler signals from the ascending aorta. After anesthesia induction and stabilization, the probe is positioned at the suprasternal notch to acquire optimal Doppler waveforms. Velocity time integral (VTI), stroke volume (SV), cardiac output (CO), stroke volume variation (SVV), systemic vascular resistance (SVR), and device-calculated aortic valve area (AVA) are recorded using the manufacturer's algorithm. Only high-quality Doppler envelopes are accepted, and measurements are repeated if artifacts or poor signal quality are present. All parameters are obtained consecutively under unchanged ventilatory and hemodynamic conditions.

Echocardiography OTHER

Transthoracic echocardiography is performed immediately after USCOM measurements under unchanged anesthetic depth, ventilator settings, and patient positioning. Using a pediatric probe, suprasternal Doppler recordings are obtained from the ascending aorta, with the Doppler cursor aligned as parallel as possible to blood flow; angle correction is applied when necessary. Velocity time integral (VTI) is measured from the largest and most clearly defined spectral Doppler envelope. The aortic annulus diameter is obtained from the parasternal long-axis view during midsystole, and aortic valve area is calculated. Stroke volume is derived as aortic valve area × VTI, and cardiac output is calculated as stroke volume × heart rate. Inspiratory and expiratory VTI values are recorded to determine respiratory variation and calculate stroke volume variation. Each parameter is measured three times and averaged for analysis.

Eligibility Criteria

• Age: 6 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients aged 6 months to 15 years with ASA physical status I-II who are scheduled for elective surgery requiring general anesthesia. All participants undergo noninvasive suprasternal Doppler and transthoracic echocardiography measurements under standardized anesthetic conditions before surgical incision.

You may qualify if:

• Pediatric patients aged 6 months to 15 years
• ASA physical status I-II
• Scheduled for elective surgery requiring general anesthesia
• Written informed consent obtained from parent(s) or legal guardian(s)

You may not qualify if:

• Intracardiac or extracardiac shunts
• Aortic valve disease
• Anatomical limitation preventing suprasternal Doppler assessment
• Required Doppler angle correction \>20° during echocardiography evaluation
• Emergency surgery
• Inability to obtain informed consent

Sponsors & Collaborators

• Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital: lead

Study Sites (1)

Marmara University Faculty of medicine

Istanbul, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 15, 2026
• Study Start: March 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 15, 2022
• Last Updated: January 15, 2026

Record last verified: 2021-03

Locations

TU (1)