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

November 14, 2014 updated by: The University of Texas Health Science Center at San Antonio

An Evaluation of a Radial Arterial Line's Effect on StO2 Monitoring Using the InSpectra® Tissue Spectrometer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

47

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
    • Texas
      • San Antonio, Texas, United States, 78229
        • University Hospital

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ICU patients wiht arterial lines

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant females
  • Nursing mothers
  • Prisoners

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
StO2 values
StO2 monitoring
Device: StO2 monitoring
placement of the StO2 device/ external noninvasive
Other Names:
  • external near infrared spectroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 15 minutes

Collaborators and Investigators

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

Sponsor

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

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.

Helpful Links

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, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

February 27, 2006

First Submitted That Met QC Criteria

February 27, 2006

First Posted (Estimate)

March 1, 2006

Study Record Updates

Last Update Posted (Estimate)

November 26, 2014

Last Update Submitted That Met QC Criteria

November 14, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 045-1502-319 (Other Identifier: Institutional Review Board)

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.

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