Evaluation of a Radial Arterial Line's Effect on StO2 Monitoring
An Evaluation of a Radial Arterial Line's Effect on StO2 Monitoring Using the InSpectra® Tissue Spectrometer
1 other identifier
observational
47
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2006
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 27, 2006
CompletedFirst Posted
Study publicly available on registry
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedResults Posted
Study results publicly available
August 2, 2013
CompletedNovember 26, 2014
November 1, 2014
2.2 years
February 27, 2006
May 4, 2012
November 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tissue Oxygen Saturation (StO2) Measurement on the Extremity With a Radial Arterial Line
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
Study Arms (1)
StO2 values
StO2 monitoring
Interventions
placement of the StO2 device/ external noninvasive
Eligibility Criteria
ICU patients wiht arterial lines
You may qualify if:
- Standard of care placement of arterial line
- years of age or older
You may not qualify if:
- Pregnant females
- Nursing mothers
- Prisoners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
San Antonio, Texas, 78229, United States
Related Links
Limitations and Caveats
Eighteen subjects were not included in final analysis due to incomplete data sets; unsuccessful arterial line placement, technical problems in applying StO2 device, unreliable data or partial data.
Results Point of Contact
- Title
- Jane Youngers
- Organization
- UTHSCSA
Study Officials
- PRINCIPAL INVESTIGATOR
Lopez P Peter, M.D.
University of Texas Health Science Center San Antonio
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2006
First Posted
March 1, 2006
Study Start
January 1, 2006
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
November 26, 2014
Results First Posted
August 2, 2013
Record last verified: 2014-11