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POGO-2 Study

  • Status
    Accepting Candidates
  • Age
    12 Years - 18 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

Details

Full study title Pediatric HemOdynamic MonitorinG TechnOlogy 2-cohort Study
Protocol number OCR45039
ClinicalTrials.gov ID NCT04465370

Eligibility

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 鈮� moderate pulmonary hypertension (PAPm > 25mmHg, PVRI > 3.0 WUxm2)

  • Presence of intracardiac shunting (i.e., ASD, VSD)

  • Aorto-pulmonary collaterals

  • 鈮� 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)

Lead researcher

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  2. Step
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  4. Step
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