Pediatric Cardiac Output Monitoring Observational Study

Pediatric ALL Clinical Trial

— POGO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04465370
• Other study ID #: 2019-08
• Status: Completed
• Start date: September 2, 2020
• Est. completion date: January 5, 2023

Study information

• Verified date: October 2023
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: January 5, 2023
• Est. primary completion date: January 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pediatric ALL

Intervention

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.

Locations

Country	Name	City	State
United States	UF Health Shands Children's Hospital	Gainesville	Florida
United States	Texas Children's Hospital	Houston	Texas
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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