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Utility of Thenar Near Infrared Spectroscopy (NIRS) in Pediatric Patients With Heart Failure

Recruitingn/aAges any - 25 YearsAllUniversity of Florida
NCT02368041 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a single-center, non-randomized study.The study staff will use the InSpectraTM tissue oxygen saturation (StO2) monitor manufactured by Hutchinson Technology to measure baseline StO2 levels after applying the noninvasive probe to the thenar eminence. After a stable reading is obtained, a blood pressure cuff will be inflated 40 mmHg above the obtained systolic pressure and the rate of desaturation (Rdes; % × sec-1) will be recorded. After 3 minutes or once the StO2 level comes to zero (whichever is earlier), the cuff pressure will be released and the rate of reperfusion (Rres; % × sec-1) will be measured. The investigators hypothesize that heart failure in children causes a baseline lower thenar tissue oxygen saturation (StO2), a faster rate of desaturation (Rdes) and a prolonged rate of reperfusion (Rres). The investigators also hypothesize that these changes will correlate with t

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📋 Eligibility rules (as published)
Inclusion Criteria: * Heart failure patients under 25 years of age with a diagnosis of cardiomyopathy, myocarditis or univentricular palliation for congenital heart disease who are stable on their medical management will be enrolled. Exclusion Criteria: 1. Patients presenting with acute deterioration in clinical status 2. Patients with active infection 3. Patients with autoimmune vasculitis disorder 4. Patients with limb deformities and painful disorders of extremities 5. Patients with underlying bone disorders, (e.g. osteogenesis imperfecta) 6. Patients with severe anemia (Hb \<7g/dL) 7. Patients with peripheral vascular disease which can alter the microcirculation
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What it tests

  • InSpectraTM StO2 monitor
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Where

1 site
University of Florida
Gainesville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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