CClinicalTrials.gg
CompletedNCT00298090Updated Nov 26, 2014Results posted

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

An observational study in Oxygenation, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-26.

Sponsored by The University of Texas Health Science Center at San Antonio · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
47
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Oxygenation

Keywords

  • Oxygenation
03

In context

Lead sponsor

The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

ICU patients wiht arterial lines

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant females
  • Nursing mothers
  • Prisoners
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
47 participants (actual)
Patient registry
No

Groups and cohorts

  • StO2 values

    StO2 monitoring

    Device: StO2 monitoring

Interventions

  • DeviceStO2 monitoring

    placement of the StO2 device/ external noninvasive

    Also known as: external near infrared spectroscopy

06

What researchers measure

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.

    Time frame: up to 15 minutes

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Results

Posted Aug 2, 2013
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.

Participant flow

Subjects were recruited from inpatients at a local hospital's Intensive Care Unit (ICU)

Participant flow — Overall Study
MilestoneStO2 Values Pre and Post Arterial Line Placement
Started47
Completed29
Not completed18

Outcome measures

PrimaryTissue 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.

Time frame:
up to 15 minutes
Reported as:
Mean · StO2 percent saturation
Tissue Oxygen Saturation (StO2) Measurement on the Extremity With a Radial Arterial Line
StO2 percent saturationStO2 Values
Tissue Oxygen Saturation (StO2) Measurement on the Extremity With a Radial Arterial Line0.68 (-0.80 to 1.48)
Statistical analysis
  • StO2 Values · repeated measures model · p = 0.55 · Other: 0 · 95% CI -0.80 to 1.48A repeated measures model was used to assess whether the one-minute average StO2 values differed systematically between pre and post arterial line placement.

Adverse events

Collected over During StO2 measurement, up to 15 minutes. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
StO2—0/47 (0%)0/47 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)StO2 Values
<=18 years0
Between 18 and 65 years47
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)StO2 Values
Female19
Male28
Region of Enrollment
Region of Enrollment(participants)StO2 Values
United States47
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Study locations

1 site
  • University Hospital
    San Antonio, Texas 78229, United States
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References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00298090
Lead sponsor
The University of Texas Health Science Center at San Antonio
Responsible party
Sponsor
First posted
Mar 1, 2006
Start date
Jan 2006
Primary completion
Mar 2008
Completion
Mar 2008
Results posted
Aug 2, 2013
Last update
Nov 26, 2014

Study contacts

Lopez P Peter, M.D.
principal investigator · University of Texas Health Science Center San Antonio

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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