Recruiting

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

Sponsor:

University of Florida

Code:

NCT02368041

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Accepted

Interventions

InSpectraTM StO2 monitor

Study Details

Brief 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.

Conditions

Heart Failure

Study ID

NCT02368041

Start date

May, 2015

Status verified date

Feb, 2026

Completion date

May 10, 2027

Anticipated

Primary completion date

Dec 10, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Accepted

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

Study Design

Enrollment

130 participants

Anticipated

Interventions and Outcome Measures

Arms

InSpectraTM StO2

InSpectraTM StO2 monitor manufactured by Hutchinson Technology Inc. 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 instantaneously and the rate of reperfusion (Rres; % × sec-1) will be measured. The measurement will be continued until the StO2 returns to the baseline value.

Interventions

InSpectraTM StO2 monitor

Primary outcome measure

Baseline StO2 percentage [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Dipankar Gupta, MD

352-273-7770 dgupta@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Dipankar Gupta, MD

352-273-7770 dgupta@ufl.edu

Principal Investigator:

Dipankar Gupta, MD

More Information

Sponsor

University of Florida

Last update posted

Mar 12, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-03-12.