Status:
COMPLETED
Pediatric Cardiac Output Monitoring Observational Study
Lead Sponsor:
Edwards Lifesciences
Conditions:
Pediatric ALL
Eligibility:
All Genders
12-18 years
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 2 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 5 2023
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT04465370
Start Date
September 2 2020
End Date
January 5 2023
Last Update
November 18 2024
Active Locations (3)
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1
UF Health Shands Children's Hospital
Gainesville, Florida, United States, 32610
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
3
Texas Children's Hospital
Houston, Texas, United States, 77030