Utility of Thenar Near Infrared Spectroscopy (NIRS) in Pediatric Patients With Heart Failure
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any - 25 |
| Updated: | 3/9/2019 |
| Start Date: | May 2015 |
| End Date: | March 2020 |
| Contact: | Dipankar Gupta, MD |
| Email: | dgupta@ufl.edu |
| Phone: | 352-273-7770 |
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.
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.
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.
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.
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
We found this trial at
1
site
Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Dipankar Gupta, MD
Phone: 352-273-7770
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
Click here to add this to my saved trials
