Multi-Site Near Infrared Spectroscopy (NIRS) Monitoring of Children During Tilt Table Testing
NIRS & Tilt
Use of Multi-site Near Infrared Spectroscopy (NIRS) Monitoring for Hemodynamic Assessment During Tilt Table Testing in Children
1 other identifier
observational
22
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 10, 2008
CompletedFirst Posted
Study publicly available on registry
April 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedFebruary 13, 2012
February 1, 2012
2.8 years
April 10, 2008
February 9, 2012
Conditions
Keywords
Study Arms (1)
1
Children who present to the heart center exercise stress lab for investigation of syncope
Eligibility Criteria
Children ages 7 through 21 years who present to exercise stress lab for investigation of syncope.
You may qualify if:
- Between the ages of 7 and 21 years
- Referred to the exercise stress lab due to syncope
You may not qualify if:
- Under 7 or over 21 years of age
- Referred to the exercise stress lab for anything other than syncope
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related 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.
PMID: 20204346RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rohit Rao, MD
Medical College of Wisconsin/Children's Hospital of Wisconsin
- PRINCIPAL INVESTIGATOR
John Hambrook, MD
Medical College of Wisconsin/Children's Hospital of Wisconsin
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Pediatrics Cardiology
Study Record Dates
First Submitted
April 10, 2008
First Posted
April 16, 2008
Study Start
January 1, 2008
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
February 13, 2012
Record last verified: 2012-02