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CompletedNCT00659464NIRS & TiltUpdated Feb 13, 2012

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

An observational study in Syncope, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 7 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-13.

Sponsored by Medical College of Wisconsin · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
22
Ages
7 Years to 21 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Syncope

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Keywords

  • Infrared Spectroscopy
  • Syncope
  • Tilt Table Testing
03

In context

Syncope

226 studies on the registry are indexed under Syncope; 45 are open to participants now.

This study's enrollment of 22 is below the median of 221 across 91 observational studies indexed under Syncope.

Browse Syncope studies →

Lead sponsor

Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.

Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
7 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children ages 7 through 21 years who present to exercise stress lab for investigation of syncope.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Under 7 or over 21 years of age
  • Referred to the exercise stress lab for anything other than syncope
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
22 participants (actual)

Groups and cohorts

  • 1

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

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Study locations

1 site
  • Children's Hospital of Wisconsin
    Milwaukee, Wisconsin 53226, United States
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References and documents

Publications

  • 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. PubMed 20204346 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00659464
Lead sponsor
Medical College of Wisconsin
Collaborators
Children's Hospital and Health System Foundation, Wisconsin
Responsible party
John Hambrook (Assistant Professor, Pediatrics Cardiology, Medical College of Wisconsin) — Principal investigator
First posted
Apr 16, 2008
Start date
Jan 2008
Primary completion
Oct 2010
Completion
Oct 2010
Last update
Feb 13, 2012

Study contacts

Rohit Rao, MD
principal investigator · Medical College of Wisconsin/Children's Hospital of Wisconsin
John Hambrook, MD
principal investigator · Medical College of Wisconsin/Children's Hospital of Wisconsin

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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