Pediatric Cardiac Output Monitoring Observational Study (POGO)

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

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 Overview

• Status: Completed
• Conditions: Pediatric ALL
• Intervention / Treatment: Device: Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight

• Study Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health Shands Children's Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Males and Females, 12 to 18 years of age at the time of screening. Who presenting to Cardiac Catheterization Lab for right heart catheterizations.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	Duration of cardiac catheterization procedure, an average of 2 hours

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

Collaborators and Investigators

• Sponsor: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Actual): January 5, 2023
• Study Completion (Actual): January 5, 2023

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: September 13, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Cardiac Output; Hemodynamic Monitoring
• Other Study ID Numbers: 2019-08 (Other Identifier: Assistance Publique Hopitaux de Marseille)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes