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

This study has been completed.
Sponsor:
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
John Hambrook, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00556231
First received: November 7, 2007
Last updated: January 2, 2013
Last verified: January 2013

November 7, 2007
January 2, 2013
November 2007
December 2012   (final data collection date for primary outcome measure)
regional oxygen saturations in 4 sites [ Time Frame: during exercise stress testing ] [ Designated as safety issue: No ]
regional oxygen saturations in 4 sites [ Time Frame: during exercise stress testing ]
Complete list of historical versions of study NCT00556231 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Multi-site Near Infrared Spectroscopy (NIRS) Monitoring of Children During Exercise
Use of Multi-site Near Infrared Spectroscopy (NIRS) Monitoring for Global Hemodynamic Assessment During Exercise Testing in Children With and Without Heart Disease

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Congenital Heart Disease
Not Provided
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
6 Years to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00556231
CHW 07/198
No
John Hambrook, Medical College of Wisconsin
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Principal Investigator: John Hambrook, MD Children's Hospital and Health System Foundation, Wisconsin
Medical College of Wisconsin
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP