We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00659464
First Posted: April 16, 2008
Last Update Posted: February 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
John Hambrook, Medical College of Wisconsin
  Purpose

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.


Condition
Syncope

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of Multi-site Near Infrared Spectroscopy (NIRS) Monitoring for Hemodynamic Assessment During Tilt Table Testing in Children

Resource links provided by NLM:


Further study details as provided by John Hambrook, Medical College of Wisconsin:

Enrollment: 22
Study Start Date: January 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Children who present to the heart center exercise stress lab for investigation of syncope

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659464


Locations
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Investigators
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
  More Information

Publications:
Responsible Party: John Hambrook, Assistant Professor, Pediatrics Cardiology, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00659464     History of Changes
Other Study ID Numbers: CHW 08/22
First Submitted: April 10, 2008
First Posted: April 16, 2008
Last Update Posted: February 13, 2012
Last Verified: February 2012

Keywords provided by John Hambrook, Medical College of Wisconsin:
Infrared Spectroscopy
Syncope
Tilt Table Testing

Additional relevant MeSH terms:
Syncope
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms