Multi-Site Near Infrared Spectroscopy (NIRS) Monitoring of Children During Tilt Table Testing

NCT ID: NCT00659464

Last Updated: 2012-02-13

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

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-10-31

Brief Summary

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PURPOSE OF THE STUDY

This study will explore the use of multi-site NIRS monitoring during tilt table testing, combining somatic and cerebral saturations data with hemodynamic data to establish the non-invasive assessment of global cardiac output distribution trends.

HYPOTHESIS / SPECIFIC AIMS

Study Aims: To evaluate the utility of multi-site NIRS monitoring in the cardiovascular hemodynamic assessment of children and adolescents during tilt table testing by establishing a non-invasive method to predict cardiac output maldistribution with the use of two-site NIRS monitoring in children and adolescents with syncope.

Detailed Description

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Conditions

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Syncope

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Children who present to the heart center exercise stress lab for investigation of syncope

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Between the ages of 7 and 21 years
* Referred to the exercise stress lab due to syncope

Exclusion Criteria

* Under 7 or over 21 years of age
* Referred to the exercise stress lab for anything other than syncope
Minimum Eligible Age

7 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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Rohit Rao, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin/Children's Hospital of Wisconsin

John Hambrook, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin/Children's Hospital of 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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Rao RP, Danduran MJ, Dixon JE, Frommelt PC, Berger S, Zangwill SD. Near infrared spectroscopy: guided tilt table testing for syncope. Pediatr Cardiol. 2010 Jul;31(5):674-9. doi: 10.1007/s00246-010-9683-z. Epub 2010 Mar 4.

Reference Type RESULT
PMID: 20204346 (View on PubMed)

Other Identifiers

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CHW 08/22

Identifier Type: -

Identifier Source: org_study_id

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