Pediatric Cardiac Output Monitoring Observational Study
Completed
Conditions studied: Pediatric ALL
In brief
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.
Key facts
- Study ID
- NCT04465370
- Run by
- Edwards Lifesciences
- People needed
- 89
- Starts
- 2020-09-02
- Expected to finish
- 2023-01-05
- Last updated by the study team
- 2024-11-18
Who can join
Age: 12 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- UF Health Shands Children's Hospital — Gainesville, Florida, United States
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Texas Children's Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
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