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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00298090
First received: February 27, 2006
Last updated: June 28, 2013
Last verified: June 2013
  Purpose

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 Intervention
Oxygenation
Device: StO2 monitoring

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Tissue Oxygen Saturation (StO2) Measurement on the Extremity With a Radial Arterial Line [ Time Frame: up to 15 minutes ] [ Designated as safety issue: No ]
    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.


Enrollment: 47
Study Start Date: January 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
StO2 values
StO2 monitoring
Device: StO2 monitoring
placement of the StO2 device/ external noninvasive
Other Name: external near infrared spectroscopy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00298090

Locations
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
Principal Investigator: Lopez P Peter, M.D. University of Texas Health Science Center San Antonio
  More Information

Additional Information:
No publications provided

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00298090     History of Changes
Other Study ID Numbers: 045-1502-319, 045-1502-319
Study First Received: February 27, 2006
Results First Received: May 4, 2012
Last Updated: June 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at San Antonio:
Oxygenation

ClinicalTrials.gov processed this record on September 18, 2014