To assess Cardiac Output Monitoring in pediatric subjects by comparing FloTrac and ClearSight system to intermittent thermodilution Swan-Ganz, in order to expand the indications of FloTrac, ClearSight and Swan-Ganz thermodilution pulmonary artery catheter to the pediatric population 12 to 18 years of age.
Study Type
OBSERVATIONAL
Enrollment
89
A Swan-Ganz catheter, FloTrac transducer, ClearSight finger cuff and ForeSight Elite sensors will be placed prior to the start of the catheterization procedure. Intermittent cardiac output and other hemodynamic parameters will be collected throughout the duration of the procedure and analyzed according to the Statistical Analysis Plan.
UF Health Shands Children's Hospital
Gainesville, Florida, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Texas Children's Hospital
Houston, Texas, United States
Bias of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
Bias of FloTrac Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis
Time frame: Duration of cardiac catheterization procedure, an average of 2 hours
Precision of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
Precision of FloTrac Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis
Time frame: Duration of cardiac catheterization procedure, an average of 2 hours
Bias of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
Bias of ClearSight Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis
Time frame: Duration of cardiac catheterization procedure, an average of 2 hours
Precision of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
Precision of ClearSight Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis
Time frame: Duration of cardiac catheterization procedure, an average of 2 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.