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

Recruiting · NCT02368041 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Florida

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Heart Failure

Interventions studied

InSpectraTM StO2 monitor

What this trial 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.

Who can take part

Age range

Up to 25 Years

Sex

All (male and female)

Healthy volunteers

Yes - healthy volunteers may be accepted

Phase

Not specified

Study type

Observational (researchers observe without assigning treatment)

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

Where it is running

1 location listed across 1 US state.

University of Florida - Gainesville, Florida, United States

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →