Use of Near Infrared Spectroscopy to Measure Intracranial ScvO2

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Thiele, MD, University of Virginia
ClinicalTrials.gov Identifier:
NCT01746576
First received: October 29, 2012
Last updated: April 15, 2014
Last verified: December 2012
  Purpose

The purpose of this study is to determine whether analysis of near infrared absorbance signals that occur at different frequencies might provide information about the difference in oxygen saturation between arterial and venous blood.


Condition Intervention
Healthy
Other: Use of impedance threshold device during spontaneous ventilation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Estimated venous oxygen saturation [ Time Frame: From 5 to 6:59 minutes after applying the impedance threshold device ] [ Designated as safety issue: No ]
    Oxygen saturation will be calculated from the five minute period of time prior to use of the impedance threshold device (0-4 mins), and then again in the 2 minute period after the impedance threshold device is applied (5-6 mins)


Estimated Enrollment: 20
Study Start Date: September 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
All
All subjects will undergo spontaneous ventilation through an impedance threshold device and ScvO2 will be recorded before and after
Other: Use of impedance threshold device during spontaneous ventilation

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult 18-65 years of age

Exclusion Criteria:

  • Dilated cardiomyopathy
  • Congestive heart failure
  • Pulmonary hypertension
  • Severe aortic stenosis
  • Flail chest
  • Chest pain
  • Shortness of breath
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01746576

Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
  More Information

Additional Information:
Publications:
Responsible Party: Robert Thiele, MD, Assistant Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT01746576     History of Changes
Other Study ID Numbers: 16422
Study First Received: October 29, 2012
Last Updated: April 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
volunteers

ClinicalTrials.gov processed this record on April 15, 2014