Pediatric Cardiac Output Monitoring Observational Study
- Conditions
- Pediatric ALL
- Registration Number
- NCT04465370
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 89
- Subjects who are 12 to 18 years of age
- Subjects who have signed the Informed Consent Form
- Subjects who are projected to receive Swan-Ganz catheter as part of procedure/standard of care with intermittent cardiac output measures
- For those Subjects who have had a cardiac transplant,Subjects who are at least 2 weeks post cardiac transplantation
- Subjects with planned pressure monitoring with an arterial line
- Subjects with contraindications for Pulmonary Artery Catheters Placement and monitoring (recurrent sepsis, or with hypercoagulopathy);
- Subjects with contraindications for Arterial Line Placement;
- Subjects with an extreme contraction of the smooth muscle in the arteries and arterioles in the lower arm and hand (i.e., Raynaud's Disease).
- Subjects with a physical site area too limited for proper Sensor placement
- Subjects with finger size less than the smallest finger cuff size
- Documented ≥ moderate pulmonary hypertension (PAPm > 25mmHg, PVRI > 3.0 WUxm2)
- Presence of intracardiac shunting (i.e., ASD, VSD)
- Aorto-pulmonary collaterals
- ≥ Moderate tricuspid regurgitation, per echocardiogram criteria
- > Moderate Aortic or pulmonary regurgitation, per echocardiogram criteria
- Persistent cardiac arrythmias during the cardiac catheterization period (> 3min)
- Vascular abnormalities of the arterial system (i.e., connective tissue disorders, mid-aortic syndrome)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bias of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output Duration of cardiac catheterization procedure, an average of 2 hours Bias of FloTrac Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis
Precision of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output Duration of cardiac catheterization procedure, an average of 2 hours Precision of FloTrac Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis
Bias of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output Duration of cardiac catheterization procedure, an average of 2 hours Bias of ClearSight Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis
Precision of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output Duration of cardiac catheterization procedure, an average of 2 hours Precision of ClearSight Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
UF Health Shands Children's Hospital
🇺🇸Gainesville, Florida, United States