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

Congenital Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00556231
• Other study ID #: CHW 07/198
• Status: Completed
• Phase: N/A
• First received: November 7, 2007
• Last updated: January 2, 2013
• Start date: November 2007
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 20 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Children's Hospital and Health System Foundation, Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	regional oxygen saturations in 4 sites		during exercise stress testing	No