Multi-site Near Infrared Spectroscopy (NIRS) Monitoring of Children During Exercise
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
Children and adolescents from age 6 to 20 undergoing exercise stress testing
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| United States, Wisconsin | |
| Children's Hospital of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| 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 Diseases Heart Defects, Congenital Cardiovascular Diseases Cardiovascular Abnormalities Congenital Abnormalities |
ClinicalTrials.gov processed this record on June 18, 2013