Measuring tissue oxygen levels in children with heart failure
Utility of Thenar Near Infrared Spectroscopy (NIRS) in Pediatric Patients With Heart Failure
This study is testing how oxygen levels in the tissues of children with heart failure compare to healthy kids to see if these levels change with their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | N/A to 25 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT02368041 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate tissue oxygen saturation levels in pediatric patients with heart failure using a non-invasive InSpectraTM monitor. The study will measure baseline oxygen saturation in the thenar eminence and assess how these levels change during induced desaturation and reperfusion. The investigators hypothesize that heart failure in children leads to lower baseline oxygen saturation and altered desaturation and reperfusion rates, which may correlate with the severity of the condition. Healthy children will also be evaluated for comparison, while clinical care will remain at the discretion of the treating physicians.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients under 25 years old with stable heart failure due to cardiomyopathy, myocarditis, or congenital heart disease.
Not a fit: Patients experiencing acute clinical deterioration, active infections, or other specified conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the severity of heart failure in children, potentially leading to improved monitoring and management strategies.
How similar studies have performed: While similar approaches have been explored, this specific application of NIRS in pediatric heart failure is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Dipankar Gupta, MD — University of Florida
- Study coordinator: Dipankar Gupta, MD
- Email: dgupta@ufl.edu
- Phone: 352-273-7770
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.