Pediatric Cardiac Output Monitoring Observational Study (POGO)

September 13, 2024 updated by: Edwards Lifesciences

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
Duration of cardiac catheterization procedure, an average of 2 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: Duration of the procedure through 30 days after procedure, plus or minus 14 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Edwards Lifesciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 2, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 5, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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