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

University of Florida · NCT02368041

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Up to age 25 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
130
US sites recruiting
1
Study start
May 2015
Record last updated
March 12, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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 the severity of heart failure. The results of this study will provide groundwork for studies looking at correlation of therapy modification based on the combination thenar StO2 and clinical presentation.

Being studied: InSpectraTM StO2 monitor

Conditions: Heart Failure

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

  • Patients presenting with acute deterioration in clinical status
  • Patients with active infection
  • Patients with autoimmune vasculitis disorder
  • Patients with limb deformities and painful disorders of extremities
  • Patients with underlying bone disorders, (e.g. osteogenesis imperfecta)
  • Patients with severe anemia (Hb \<7g/dL)
  • Patients with peripheral vascular disease which can alter the microcirculation

Recruiting US locations

  • University of Florida

    Gainesville, FL 32610

    Site contact: Dipankar Gupta, MD · 352-273-7770 · dgupta@ufl.edu

Study contacts (from the official record)

  • Dipankar Gupta, MD · 352-273-7770 · dgupta@ufl.edu
Utility of Thenar Near Infrared Spectroscopy (NIRS) in Pediatric… (NCT02368041) | Bored Studies