NCT02368041Recruiting
Utility of Thenar Near Infrared Spectroscopy (NIRS) in Pediatric Patients With Heart Failure
Source: ClinicalTrials.gov · Last updated 12 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 130 (estimated)
- First submitted
- 13 Feb 2015
- Start date
- May 2015
- Primary completion date
- 10 Dec 2026
- Lead sponsor
- University of Florida
- Diseases
- Heart failure
- NCT number
- NCT02368041
What you commit to
- Study type: Observational
- Planned participants: 130
- From May 2015 to the primary completion date, 10 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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 peripheral vascular disease which can alter the microcirculation
Other
- Patients presenting with acute deterioration in clinical status
- Patients with severe anemia (Hb \<7g/dL)
Who the study is looking for
- 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.
Age in the registry: - to 25 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.