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

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ClinicalTrials.gov Identifier: NCT02368041
Recruitment Status : Recruiting
First Posted : February 20, 2015
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment
Heart Failure Device: InSpectraTM StO2 monitor

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Utility of Thenar Near Infrared Spectroscopy (NIRS) in Pediatric Patients With Heart Failure
Study Start Date : May 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
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.
Device: InSpectraTM StO2 monitor
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 Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   up to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Stable Heart failure patients under 25 years of age with a diagnosis of cardiomyopathy, myocarditis or univentricular palliation for congenital heart disease in a primary pediatric cardiologist office
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02368041


Contacts
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Contact: Dipankar Gupta, MD 352-273-7770 dgupta@ufl.edu

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Dipankar Gupta, MD    352-273-7770    dgupta@ufl.edu   
Principal Investigator: Dipankar Gupta, MD         
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Dipankar Gupta, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02368041     History of Changes
Other Study ID Numbers: IRB201400800
First Posted: February 20, 2015    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant will not be shared to avoid risk of loss of confidentiality.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases