Clinical trial NCT00556231: Multi-site Near Infrared Spectroscopy (NIRS) Monitoring of Children During Exercise
Official title: Use of Multi-site Near Infrared Spectroscopy (NIRS) Monitoring for Global Hemodynamic Assessment During Exercise Testing in Children With and Without Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: NIRS
cardiac output
anaerobic threshold
exercise stress
congenital heart defect
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Children's Hospital and Health System Foundation, Wisconsin
First posted: 2007-11-09
Enrollment: 51
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents from age 6 to 20 undergoing exercise stress testing

Brief summary: Near Infrared Spectroscopy (NIRS) monitoring has proven beneficial in increasing safety and improving patient care during pediatric cardiac surgery and during Pediatric Intensive Care Unit (PICU) stays. NIRS estimates the amount of oxygen in tissues by comparing the tissue's absorption of two wavelengths of light corresponding to hemoglobin carrying oxygen and hemoglobin without oxygen.

During cardiac surgery, multi-site NIRS monitoring is used to determine the heart's output by comparing the amount of oxygen available to discrete regions of the body nourished by different parts of the circulatory system. NIRS leads placed on the forehead detect oxygen available to the brain (cerebral), while leads placed over the kidney reflect oxygen available to the internal organs (somatic).

NIRS monitoring has been used for studying muscle oxygen usage during exercise in normal and disease states. Cerebral oxygenation at peak exercise at has been studied with NIRS monitoring. The use of multi-site NIRS monitoring during exercise stress testing for studying cardiac output through the patterning of somatic and cerebral oxygenation in combination with exercise stress test data has not been researched.

We hypothesize that addition of multi-site NIRS monitoring to the standard data collection already achieved during exercise testing, will enable calculation of anaerobic threshold and cardiac output prediction. This will assist in determining appropriate timing for surgical intervention, predicting the post operative course and testing response to medication.


Eligibility criteria: Inclusion Criteria:

* Children and adolescents from age 6 to 20 undergoing exercise stress testing on treadmill

Exclusion Criteria:

* Children and adolescents unable to exercise or unable to follow directions or unable to understand English.

Primary outcomes:
measure: regional oxygen saturations in 4 sites
timeFrame: during exercise stress testing
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Children's Hospital and Health System Foundation, Wisconsin
name: John Hambrook, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Danduran MJ, Dixon JE, Rao RP. Near infrared spectroscopy describes physiologic payback associated with excess postexercise oxygen consumption in healthy controls and children with complex congenital heart disease. Pediatr Cardiol. 2012 Jan;33(1):95-102. doi: 10.1007/s00246-011-0097-3. Epub 2011 Sep 3.
citation: Rao RP, Danduran MJ, Loomba RS, Dixon JE, Hoffman GM. Near-infrared spectroscopic monitoring during cardiopulmonary exercise testing detects anaerobic threshold. Pediatr Cardiol. 2012 Jun;33(5):791-6. doi: 10.1007/s00246-012-0217-8. Epub 2012 Feb 19.
citation: Rao RP, Danduran MJ, Hoffman GM, Ghanayem NS, Berger S, Frommelt PC. Cerebral hemodynamics in the presence of decreased systemic venous compliance in patients with Fontan physiology may limit anaerobic exercise capacity. Pediatr Cardiol. 2010 Feb;31(2):208-14. doi: 10.1007/s00246-009-9585-0.