USCOMNCT07342842
Comparison of the Ultrasonic Cardiac Output Monitor and Echocardiography for Hemodynamic Assessment in Pediatric Anesthesia
An observational study of USCOM and Echocardiography, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 15 years
- Conditions the study is for
- USCOM, Echocardiography, Echocardiography Guided Fluid Management
- What is being tested?
- USCOM and Echocardiography
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 15 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Faculty of medicine
Istanbul
About this study
Official title: Comparison of the Ultrasonic Cardiac Output Monitor and Echocardiography for Hemodynamic Assessment in Pediatric Anesthesia: A Prospective Observational Study
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.
Read the detailed description
This prospective observational pilot study is designed to evaluate the agreement between Ultrasound Cardiac Output Monitor (USCOM) measurements and transthoracic echocardiography-derived hemodynamic parameters in pediatric patients undergoing elective surgery under standardized general anesthesia.
After anesthesia induction and airway management, patients are allowed to reach stable hemodynamic and ventilatory conditions. Heart rate, noninvasive blood pressure, peripheral oxygen saturation, tidal volume, respiratory rate, and positive end-expiratory pressure are documented to confirm comparable physiological conditions during all measurements.
All measurements are performed before surgical incision and under unchanged ventilator settings, anesthetic depth, and patient positioning. No fluid administration, vasoactive medication, or ventilatory adjustments are made between techniques.
USCOM measurements are obtained first using a suprasternal approach to acquire spectral Doppler signals. Device-derived parameters, including 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 consecutively during spontaneous or controlled mechanical ventilation without apnea. Only Doppler signals with clearly defined spectral envelopes are accepted. Measurements with artifacts or poor signal quality are repeated until optimal tracings are achieved.
Immediately afterward, transthoracic echocardiography is performed using a pediatric probe. Suprasternal Doppler recordings are aligned as parallel as possible to blood flow in the ascending aorta, and angle correction is applied when required. 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 SVV.
USCOM and echocardiography measurements are performed sequentially within a 1-2-minute time window to minimize the impact of temporal hemodynamic variability. Each parameter is measured three consecutive times, and the average value is used for statistical analysis.
All examinations are conducted by a single experienced operator who completed supervised echocardiography training and independently performed at least 30 validated measurements before study initiation to minimize interobserver variability.
The primary objective is to assess agreement between USCOM and echocardiography for stroke volume and cardiac output measurements. Secondary objectives include correlation of suprasternal VTI values, agreement in SVV measurements, comparison of USCOM-calculated versus echocardiography-derived aortic valve area, and Bland-Altman analysis of all paired hemodynamic parameters.
- Being tested
- USCOM, Echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USCOMOther
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.
EchocardiographyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
To evaluate the strength of association between velocity time integral (VTI) values obtained using suprasternal Doppler with USCOM and those measured by transthoracic echocardiography under stable anesthetic and ventilatory conditions.
Measured: 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
To assess agreement between USCOM-derived and echocardiography-derived stroke volume variation (SVV) values calculated from inspiratory and expiratory Doppler measurements using paired Bland-Altman analysis and correlation methods.
Measured: 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
To compare aortic valve area (AVA) values automatically calculated by USCOM using biometric algorithms with AVA values derived from echocardiographic aortic annulus measurement and Doppler velocity time integral.
Measured: 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
To evaluate agreement between USCOM and echocardiography for paired hemodynamic variables, including stroke volume, cardiac output, velocity time integral, stroke volume variation, and aortic valve area, using Bland-Altman analysis with calculation of bias and limits of agreement.
Measured: Single intraoperative assessment after induction and stabilization and before surgical incision (measurements obtained sequentially within 1-2 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Mar 2021
- Primary completion1 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for USCOMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Kuzlu, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342842
- Sponsor's protocol ID
- USCOM-Echo
- Status last verified
- Mar 2021
- First submitted
- 6 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Ultrasonic Cardiac Output Monitor and Echocardiography for Hemodynamic Assessment in Pediatric Anesthesia: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07342842
- Acronym / sponsor ID
- USCOM-Echo
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective observational pilot study is designed to evaluate the agreement between Ultrasound Cardiac Output Monitor (USCOM) measurements and transthoracic echocardiography-derived hemodynamic parameters in pediatric patients undergoing elective surgery under standardized general anesthesia.
After anesthesia induction and airway management, patients are allowed to reach stable hemodynamic and ventilatory conditions. Heart rate, noninvasive blood pressure, peripheral oxygen saturation, tidal volume, respiratory rate, and positive end-expiratory pressure are documented to confirm comparable physiological conditions during all measurements.
All measurements are performed before surgical incision and under unchanged ventilator settings, anesthetic depth, and patient positioning. No fluid administration, vasoactive medication, or ventilatory adjustments are made between techniques.
USCOM measurements are obtained first using a suprasternal approach to acquire spectral Doppler signals. Device-derived parameters, including 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 consecutively during spontaneous or controlled mechanical ventilation without apnea. Only Doppler signals with clearly defined spectral envelopes are accepted. Measurements with artifacts or poor signal quality are repeated until optimal tracings are achieved.
Immediately afterward, transthoracic echocardiography is performed using a pediatric probe. Suprasternal Doppler recordings are aligned as parallel as possible to blood flow in the ascending aorta, and angle correction is applied when required. 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 SVV.
USCOM and echocardiography measurements are performed sequentially within a 1-2-minute time window to minimize the impact of temporal hemodynamic variability. Each parameter is measured three consecutive times, and the average value is used for statistical analysis.
All examinations are conducted by a single experienced operator who completed supervised echocardiography training and independently performed at least 30 validated measurements before study initiation to minimize interobserver variability.
The primary objective is to assess agreement between USCOM and echocardiography for stroke volume and cardiac output measurements. Secondary objectives include correlation of suprasternal VTI values, agreement in SVV measurements, comparison of USCOM-calculated versus echocardiography-derived aortic valve area, and Bland-Altman analysis of all paired hemodynamic parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- Intracardiac or extracardiac shunts
- Aortic valve disease
- Anatomical limitation preventing suprasternal Doppler assessment
- Required Doppler angle correction >20° during echocardiography evaluation
- Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| USCOMUltrasound 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. | Other | – |
| EchocardiographyTransthoracic 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. | Other | – |
Primary outcome
Agreement Between USCOM and Echocardiography for Stroke Volume and Cardiac Output
Time frame: Intraoperative, after induction and stabilization and before surgical incision (single assessment; within 1-2 minutes between methods).
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.
4 secondary outcomes
Correlation Between USCOM VTI and Echocardiography VTI (Suprasternal Doppler)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Single intraoperative assessment after induction and stabilization and before surgical incision (measurements obtained sequentially within 1-2 minutes).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of USCOM and Echocardiography, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between USCOM and Echocardiography for Stroke Volume and Cardiac Output (time frame: Intraoperative, after induction and stabilization and before surgical incision (single assessment; within 1-2 minutes between methods).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.