Comparison of the Ultrasonic Cardiac Output Monitor and Echocardiography for Hemodynamic Assessment in Pediatric Anesthesia: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Agreement Between USCOM and Echocardiography for Stroke Volume and Cardiac Output
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 15 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Agreement Between USCOM and Echocardiography for Stroke Volume and Cardiac Output
时间窗: 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.
次要结局
- 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).)
研究者
Volkan Kuzlu
principal investigator
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
