Comparison of the Ultrasonic Cardiac Output Monitor and Echocardiography for Hemodynamic Assessme… (NCT07342842) | Clinical Trial Compass
CompletedNot Applicable
Comparison of the Ultrasonic Cardiac Output Monitor and Echocardiography for Hemodynamic Assessment in Pediatric Anesthesia
Turkey (Türkiye)57 participantsStarted 2021-03-01
Plain-language 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.
Who can participate
Age range
6 Months – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Agreement Between USCOM and Echocardiography for Stroke Volume and Cardiac Output
Timeframe: Intraoperative, after induction and stabilization and before surgical incision (single assessment; within 1-2 minutes between methods).
Trial details
NCT IDNCT07342842
SponsorSehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital