Multi-site Near Infrared Spectroscopy (NIRS) Monitoring of Children During Exercise

NCT00556231 | Completed

• 1 other identifier: CHW 07/198
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

NIRS; cardiac output; anaerobic threshold; exercise stress; congenital heart defect

Outcome Measures

Primary Outcomes (1)

• regional oxygen saturations in 4 sites

  during exercise stress testing

Study Arms (6)

1

Children with congenital heart lesions - males/females, ages 6-20, scheduled for a regular stress test

2

Children without congenital heart lesions - males/females, ages 6-20, scheduled for a regular stress test

3

4

5

6

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Children's Hospital and Health System Foundation, Wisconsin: collaborator

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

• 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.

  PMID: 21892649 RESULT

• 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.

  PMID: 22349729 RESULT

• 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.

  PMID: 19915888 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• John Hambrook, MD

  Children's Hospital and Health System Foundation, Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Pediatrics, Cardiology

Study Record Dates

• First Submitted: November 7, 2007
• First Posted: November 9, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 4, 2013

Record last verified: 2013-01

Locations

US (1)