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| ID | Type | Description | Link |
|---|---|---|---|
| 045-1502-319 | Other Identifier | Institutional Review Board |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| StO2 values | StO2 monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StO2 monitoring | Device | placement of the StO2 device/ external noninvasive |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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ICU patients wiht arterial lines
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| Name | Affiliation | Role |
|---|---|---|
| Lopez P Peter, M.D. | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | San Antonio | Texas | 78229 | United States |
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| Label | URL |
|---|---|
| device information | View source |
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Subjects were recruited from inpatients at a local hospital's Intensive Care Unit (ICU)
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| ID | Title | Description |
|---|---|---|
| FG000 | StO2 Values Pre and Post Arterial Line Placement | single arm study of StO2 in subjects undergoing placement of arterial line. Measurements of StO2 will be taken before and after arterial line placement. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | StO2 Values | StO2 values pre and post arterial line placement. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data from 18 subjects not used due to only partial data captured resulting from logistical issues. | Posted | Mean | 95% Confidence Interval | StO2 percent saturation | up to 15 minutes |
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During StO2 measurement, up to 15 minutes
No adverse events observed. 47 subjects enrolled, 29 subjects completed. Non invasive StO2 measurement device used to obtain values. No adverse events occured during the course of subjects participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | StO2 | StO2 measurements pre and post arterial line catheter placement. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jane Youngers | UTHSCSA | 210-567-2340 | youngers@uthscsa.edu |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Counts |
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| Participants |
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| 0 |
| 47 |
| 0 |
| 47 |
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