Pediatric Cardiac Output Monitoring Observational Study

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Single-Arm, Nonrandomized, Observational Study of Cardiac Output Monitoring in Pediatric Patients

Conditions
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Pediatric ALL

Intervention / Treatment
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* Device: Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstration of monitoring cardiac output with Swan-Ganz, FloTrac, and ClearSight system | Demonstrate that monitoring of cardiac output with Swan-Ganz, FloTrac, and ClearSight system is comparable as determined by the Bland-Altman method of bias. | Duration of the procedure through 30 days after procedure, plus or minus 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate that monitoring of cardiac output with Swan-Ganz, FloTrac, and ClearSight system is comparable as determined by the Critchley and Critchley method of percent error calculation. | Demonstrate that monitoring of cardiac output with Swan-Ganz, FloTrac, and ClearSight system is comparable as determined by the Critchley and Critchley method of percent error calculation. | Duration of the procedure through 30 days after procedure, plus or minus 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodynamic Monitoring, Cardiac Output