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

NCT ID: NCT00556231

Last Updated: 2013-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Heart Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Children with congenital heart lesions - males/females, ages 6-20, scheduled for a regular stress test

No interventions assigned to this group

2

Children without congenital heart lesions - males/females, ages 6-20, scheduled for a regular stress test

No interventions assigned to this group

3

No interventions assigned to this group

4

No interventions assigned to this group

5

No interventions assigned to this group

6

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital and Health System Foundation, Wisconsin

OTHER

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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John Hambrook

Assistant Professor, Pediatrics, Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Hambrook, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital and Health System Foundation, Wisconsin

Locations

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Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Danduran MJ, Dixon JE, Rao RP. Near infrared spectroscopy describes physiologic payback associated with excess postexercise oxygen consumption in healthy controls and children with complex congenital heart disease. Pediatr Cardiol. 2012 Jan;33(1):95-102. doi: 10.1007/s00246-011-0097-3. Epub 2011 Sep 3.

Reference Type RESULT
PMID: 21892649 (View on PubMed)

Rao RP, Danduran MJ, Loomba RS, Dixon JE, Hoffman GM. Near-infrared spectroscopic monitoring during cardiopulmonary exercise testing detects anaerobic threshold. Pediatr Cardiol. 2012 Jun;33(5):791-6. doi: 10.1007/s00246-012-0217-8. Epub 2012 Feb 19.

Reference Type RESULT
PMID: 22349729 (View on PubMed)

Rao RP, Danduran MJ, Hoffman GM, Ghanayem NS, Berger S, Frommelt PC. Cerebral hemodynamics in the presence of decreased systemic venous compliance in patients with Fontan physiology may limit anaerobic exercise capacity. Pediatr Cardiol. 2010 Feb;31(2):208-14. doi: 10.1007/s00246-009-9585-0.

Reference Type DERIVED
PMID: 19915888 (View on PubMed)

Other Identifiers

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CHW 07/198

Identifier Type: -

Identifier Source: org_study_id

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