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
  Purpose

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.


Condition
Congenital Heart Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • regional oxygen saturations in 4 sites [ Time Frame: during exercise stress testing ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: November 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   6 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00556231

Locations
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Investigators
Principal Investigator: John Hambrook, MD Children's Hospital and Health System Foundation, Wisconsin
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Hambrook, Assistant Professor, Pediatrics, Cardiology, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00556231     History of Changes
Other Study ID Numbers: CHW 07/198
Study First Received: November 7, 2007
Last Updated: January 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
NIRS
cardiac output
anaerobic threshold
exercise stress
congenital heart defect

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on October 23, 2014