Multi-site Near Infrared Spectroscopy (NIRS) Monitoring of Children During Exercise
|ClinicalTrials.gov Identifier: NCT00556231|
Recruitment Status : Completed
First Posted : November 9, 2007
Last Update Posted : January 4, 2013
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 or disease|
|Congenital Heart Disease|
|Study Type :||Observational|
|Actual Enrollment :||51 participants|
|Observational Model:||Case Control|
|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|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Children with congenital heart lesions - males/females, ages 6-20, scheduled for a regular stress test
Children without congenital heart lesions - males/females, ages 6-20, scheduled for a regular stress test
- regional oxygen saturations in 4 sites [ Time Frame: during exercise stress testing ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00556231
|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|