Pediatric Cardiac Output Monitoring Observational Study

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.

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Key information

Conditions

Pediatric ALL Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UF Health Shands Children's Hospital, Gainesville, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight

Device

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.

Primary outcomes

Bias of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

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

Acronym: POGO

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Jul 10, 2020
Registry last updated: Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed