- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04465370
Pediatric Cardiac Output Monitoring Observational Study (POGO)
October 3, 2023 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
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
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
- Name: Kathy Akagha
- Phone Number: (949) 250-7169
- Email: Kathy_Akagha@edwards.com
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610
- UF Health Shands Children's Hospital
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Texas
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Houston, Texas, United States, 77030
- Texas Children's Hospital
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-
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
Ages Eligible for Study
10 years to 16 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
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demonstration of monitoring cardiac output with Swan-Ganz, FloTrac, and ClearSight system
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 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.
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
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)
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 (Actual)
October 5, 2023
Last Update Submitted That Met QC Criteria
October 3, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2019-08 (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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