Validation of Minimally Invasive and Noninvasive Hemodynamic Monitoring in Adolescents: The Pediatric Cardiac Output Monitoring Observational (POGO) Study.

Abstract

Objectives: Minimally invasive cardiac output (CO) monitoring technologies lack validation in the adolescent population. We aimed to test the accuracy and precision of the FloTrac arterial pressure cardiac output (APCO) and ClearSight photoplethysmography cardiac output (PPGCO; Edwards Lifesciences, Irvine, CA) technologies in adolescents undergoing elective cardiac catheterization.

Design: Prospective, single-arm, nonrandomized, observational study.

Setting: Cardiac catheterization laboratory at three freestanding pediatric hospitals in the United States.

Patients: Adolescent patients 12-18 years of age undergoing surveillance cardiac catheterization after heart transplantation.

Interventions: Swan-Ganz pulmonary artery catheterization with the intermittent thermodilution CO (iCO) technique was used as the gold standard for CO measurements. APCO was measured using an existing femoral arterial sheath, and PPGCO was measured utilizing a volumetric cuff placed on the finger of the upper extremities. Two sets of simultaneous iCO, APCO, and PPGCO measurements were compared. Bias and level of concordance were assessed using Bland-Altman analysis.

Measurements and main results: Out of the 89 subjects enrolled, 73 underwent measurements and provided a total of 60 sets of measurements for each device. The median age was 16 years (interquartile range [IQR], 14-17 yr) with a median body surface area of 1.6 m2 (IQR, 1.5-1.8 m2). The median averaged intermittent cardiac index was 2.7 L/min/m2 (IQR, 2.3-3.1 L/min/m2). FloTrac APCO mean bias was 0.32 L/min/m2 (IQR, 0.20-0.44 L/min/m2) with a precision of 0.70 L/min/m2 (IQR, 0.58-0.82 L/min/m2). ClearSight PPGCO mean bias was 0.28 L/min/m2 (95% CI, 0.16-0.41 L/min/m2) with a precision of 0.71 L/min/m2 (95% CI, 0.59-0.84 L/min/m2). No serious adverse events were reported related to the devices.

Conclusions: The minimally and noninvasive CO measurements with FloTrac and ClearSight APCO show acceptable bias and precision under standardized elective clinical conditions in an adolescent pediatric population, making them useful tools in the routine clinical management of critically ill children.