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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00298090
Enrollment
47
Registered
2006-03-01
Start date
2006-01-31
Completion date
2008-03-31
Last updated
2014-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxygenation

Keywords

Oxygenation

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.

Interventions

DEVICEStO2 monitoring

placement of the StO2 device/ external noninvasive

Sponsors

The University of Texas Health Science Center at San Antonio
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Pregnant females * Nursing mothers * Prisoners

Design outcomes

Primary

MeasureTime frameDescription
Tissue Oxygen Saturation (StO2) Measurement on the Extremity With a Radial Arterial Lineup to 15 minutesUsing 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.

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

ArmCount
StO2 Values
StO2 values pre and post arterial line placement.
47
Total47

Baseline characteristics

CharacteristicStO2 Values
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
47 Participants
Region of Enrollment
United States
47 participants
Sex: Female, Male
Female
19 Participants
Sex: Female, Male
Male
28 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 47
serious
Total, serious adverse events
0 / 47

Outcome results

Primary

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

Population: Data from 18 subjects not used due to only partial data captured resulting from logistical issues.

ArmMeasureValue (MEAN)
StO2 ValuesTissue Oxygen Saturation (StO2) Measurement on the Extremity With a Radial Arterial Line0.68 StO2 percent saturation
p-value: 0.5595% CI: [-0.8, 1.48]repeated measures model

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026