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Evaluation of a Radial Arterial Line's Effect on StO2 Monitoring

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ClinicalTrials.gov Identifier: NCT00298090
Recruitment Status : Completed
First Posted : March 1, 2006
Results First Posted : August 2, 2013
Last Update Posted : November 26, 2014
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Study Description
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Brief Summary:
Measuring tissue oxygen saturation (St02) in the thenar eminence is emerging as a measurement of resuscitation. However, no study to our knowledge has evaluated the effects of an arterial line in the radial artery supplying this muscle bed on St02. This study will attempt to address the interaction between an arterial line and St02 monitoring in the thenar eminence. As most patients who require aggressive resuscitation will have an arterial line, it is important to understand what if any impact this will have on St02 in the same extremity.

Condition or disease Intervention/treatment
Oxygenation Device: StO2 monitoring

Study Design
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Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Evaluation of a Radial Arterial Line's Effect on StO2 Monitoring Using the InSpectra® Tissue Spectrometer
Study Start Date : January 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008
Groups and Cohorts
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Group/Cohort Intervention/treatment
StO2 values
StO2 monitoring
 Device: StO2 monitoring
placement of the StO2 device/ external noninvasive
Other Name: external near infrared spectroscopy


Outcome Measures
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Primary Outcome Measures :
  1. Tissue Oxygen Saturation (StO2) Measurement on the Extremity With a Radial Arterial Line [ Time Frame: up to 15 minutes ]
    Using near-infrared spectroscopy, the external device recorded raw StO2 values every 3.5 seconds for approximately 5 minutes prior to and immediately following the insertion of a radial arterial catheter on the ipsilateral side. The raw values were then compiled into one-minute averages.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ICU patients wiht arterial lines
Criteria

Inclusion Criteria:

  • Standard of care placement of arterial line
  • 18 years of age or older

Exclusion Criteria:

  • Pregnant females
  • Nursing mothers
  • Prisoners
Contacts and Locations
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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): NCT00298090


Locations
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United States, Texas
University Hospital
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Lopez P Peter, M.D. University of Texas Health Science Center San Antonio
More Information
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Additional Information:

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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00298090    
Other Study ID Numbers: 045-1502-319
045-1502-319 ( Other Identifier: Institutional Review Board )
First Posted: March 1, 2006    Key Record Dates
Results First Posted: August 2, 2013
Last Update Posted: November 26, 2014
Last Verified: November 2014
Keywords provided by The University of Texas Health Science Center at San Antonio:
Oxygenation