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Completed

NCT Number: NCT00556231

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

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.

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Key information

Age range

6 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. regional oxygen saturations in 4 sites

    Time frame: during exercise stress testing

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Children's Hospital and Health System Foundation, Wisconsin

Registry information

Official study title

Use of Multi-site Near Infrared Spectroscopy (NIRS) Monitoring for Global Hemodynamic Assessment During Exercise Testing in Children With and Without Heart Disease

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Nov 9, 2007
Registry last updated
Jan 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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