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

Phase

N/A

Condition

Chest Pain

Congestive Heart Failure

Hyponatremia

Treatment

InSpectraTM StO2 monitor

Clinical Study ID

NCT02368041

IRB202200657

IRB201400800

Ages < 25
All Genders
Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 stableon their medical management will be enrolled.

Exclusion

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

Study Design

InSpectraTM StO2 monitor

May 01, 2015

May 10, 2026

Study Description

Heart failure patients seen in the Pediatric Cardiology Congenital Heart Center will be enrolled into the study after obtaining informed consent on the day of their evaluation. The primary pediatric cardiologist following the patient will evaluate the need for regular investigations like blood work, electrocardiogram and echocardiogram. The study staff will use the InSpectraTM tissue oxygen saturation (StO2) monitor manufactured by Hutchinson Technology to measure the baseline StO2 level 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. Similar measurements will be obtained from an otherwise healthy cohort of children who present to the Pediatric Cardiology Congenital Heart Center for evaluation of a heart murmur or chest pain. The patient's treating physician and care providers will be blinded to the study test results. All clinical care will be at the discretion of the patient's treating physicians. Only StO2 levels will be obtained using the non-invasive probe placed on the thenar eminence for the purpose of the study.

Connect with a study center

University of Florida
Gainesville, Florida 32610
United States
Active - Recruiting

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