Skip to main content
OpenTrials
Recruiting

NCT Number: NCT02368041

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

Up to 25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32610, United States

Location status: Recruiting

Location contact

Dipankar Gupta, MD

CONTACT

[email protected]

352-273-7770

Dipankar Gupta, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

InSpectraTM StO2 monitor

Device

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.

Primary outcomes

  1. Baseline StO2 percentage

    Time frame: Day 1

    The study staff will use the InSpectraTM StO2 monitor manufactured by Hutchinson Technology to measure the baseline StO2 level after applying the noninvasive probe to the thenar eminence

Secondary outcomes

  1. Occlusion- rate of desaturation (Rdes) of StO2 levels

    Time frame: Day 1

    After a stable baseline 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 for 3 min or until the StO2 level comes to zero (whichever is earlier).

  2. Recovery- rate of reperfusion (Rres) of StO2 levels

    Time frame: Day 1

    After 3 minutes from occlusion 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 for approximately 3 min.

Study contacts

Contact information is provided by the study sponsor or research team.

Dipankar Gupta, MD

CONTACT

[email protected]

352-273-7770

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2015
Primary completion
2026
Study completion
2027
First posted
Feb 20, 2015
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.