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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 25
Healthy Volunteers: t
View:

• 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.

Locations
United States
Florida
University of Florida
RECRUITING
Gainesville
Contact Information
Primary
Dipankar Gupta, MD
dgupta@ufl.edu
352-273-7770
Time Frame
Start Date: 2015-05
Estimated Completion Date: 2026-05-10
Participants
Target number of participants: 130
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Florida

This content was sourced from clinicaltrials.gov