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NCT00659464 Clinical Trial

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

Syncope Clinical Trial

— NIRS & Tilt  

Official title:
Use of Multi-site Near Infrared Spectroscopy (NIRS) Monitoring for Hemodynamic Assessment During Tilt Table Testing in Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00659464
Other study ID # CHW 08/22
Secondary ID
Status Completed
Phase N/A
First received April 10, 2008
Last updated February 9, 2012
Start date January 2008
Est. completion date October 2010

Study information
Verified date February 2012
Source Medical College of Wisconsin
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 7 Years to 21 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Hospital of Wisconsin Milwaukee Wisconsin

Sponsors (2)
Lead Sponsor Collaborator
Medical College of Wisconsin Children's Hospital and Health System Foundation, Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

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