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

February 9, 2012 updated by: John Hambrook, Medical College of Wisconsin

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Children who present to the heart center exercise stress lab for investigation of syncope

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

April 10, 2008

First Submitted That Met QC Criteria

April 10, 2008

First Posted (Estimate)

April 16, 2008

Study Record Updates

Last Update Posted (Estimate)

February 13, 2012

Last Update Submitted That Met QC Criteria

February 9, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHW 08/22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Syncope

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe