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Use of Near Infrared Spectroscopy to Measure Intracranial ScvO2

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01746576
First Posted: December 11, 2012
Last Update Posted: April 16, 2014
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.
Information provided by (Responsible Party):
Robert Thiele, MD, University of Virginia
  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: None (Open Label)
Primary Purpose: Diagnostic

Further study details as provided by Robert Thiele, MD, University of Virginia:

Primary Outcome Measures:
  • Estimated venous oxygen saturation [ Time Frame: From 5 to 6:59 minutes after applying the impedance threshold device ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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): 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
First Submitted: October 29, 2012
First Posted: December 11, 2012
Last Update Posted: April 16, 2014
Last Verified: December 2012

Keywords provided by Robert Thiele, MD, University of Virginia:
volunteers