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Tissue oxygen saturation is non-invasively measured using near-infrared spectroscopy, by two device, INVOS®(somanetics Corporation, USA ) and InSpectra™ (Hutchinson Technology, USA). Each probes are attached to both thenar muscles and vascular occlusion test (VOT) is performed. The investigators will compare the Invos® data to InSpectra™ to investigate whether tissue oxygen saturation values by INVOS® can substitute for InSpectra™.
Tissue oxygen saturation is non-invasively measured using near-infrared spectroscopy, by two device, INVOS®(somanetics Corporation, USA ) and InSpectra™ (Hutchinson Technology, USA). InSpectra™ was introduced later than INVOS®.
With InSpectra™, clinicians have used a vascular occlusion test (VOT) to evaluate dynamic changes in tissue oxygen saturation during ischemia and reperfusion, and thus, microcirculatory function. There have been little data about VOT using INVOS®, although it is more popular device.
We hypothesized that there would be a difference between the values from INVOS® and InSpectra™. The aim of this study is to evaluate changes in tissue oxygen saturation in the thenar muscle during VOT using INVOS® and comapre it to InSpectra™ in a normal population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vascular occlusion test | Experimental | The pediatric SomaSensor™ probe of INVOS® and the 15-mm sensor of InSpectra™ are placed on each thenar muscle in the same subject. The side on which the probe will be placed is randomly determined. INVOS® updates data every 5 s and data (SrO2) will be manually recorded. The data of InSpectra™ (StO2) are automatically collected and sampled every 2 s. Vascular occlusion test (VOT) is done as follows:Adult-size blood pressure cuffs are placed around each upper arm. The both cuffs are simultaneously inflated to 30 mmHg above the initial systolic blood pressure and kept inflated until the SrO2 or StO2 decreased to 40%. When the value reaches 40% or just below it, the cuff on the same side is deflated rapidly. The data will be collected until the SrO2 and StO2 values returned to the baseline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vascular occlusion test | Device | Using Invos® probe attacted to one thenar muscle, tissue oxgyenation is measured by VOT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Tissue Oxygenation Value During Ischemia and Reperfusion Period Until Basline Value Was Achieved | During vascular occlusion test, the changes of StO2 and SrO2 values can divided into 3 epoch; Desaturation, Reoxygenation and Reactive hyperemia. After data collection, the rate of desaturation and reoxygenation were calculated. | Until basline tissue oxygenation value was achieved |
| Sum of Tissue Oxygenation Value Which Above Basline Value After Reperfusion Period Until Basline Value Was Achieved | During vascular occlusion test, the changes of StO2 and SrO2 values can divided into 3 epoch; Desaturation, Reoxygenation and Reactive hyperemia. After data collection, the rate of desaturation and reoxygenation were calculated. | Until basline tissue oxygenation value was achieved |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline, Miminum and Maximum Tissue Oxygenation Value Measured by INVOS® (SrO2) Until Basline Value Was Achieved | Before VOT. basline StO2 and SrO2 were recorded and compared each other. During VOT, minimum/maximum StO2 and SrO2 were also recorded and compared each other. | Until basline tissue oxygenation value was achieved |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Tae Kim, Ph.D. | Seoul National University Hospital | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vascular Occlusion Test | The pediatric SomaSensor™ probe of INVOS® and the 15-mm sensor of InSpectra™ are placed on each thenar muscle in the same subject. The side on which the probe will be placed is randomly determined. INVOS® updates data every 5 s and data (SrO2) will be manually recorded. The data of InSpectra™ (StO2) are automatically collected and sampled every 2 s. Vascular occlusion test (VOT) is done as follows:Adult-size blood pressure cuffs are placed around each upper arm. The both cuffs are simultaneously inflated to 30 mmHg above the initial systolic blood pressure and kept inflated until the SrO2 or StO2 decreased to 40%. When the value reaches 40% or just below it, the cuff on the same side is deflated rapidly. The data will be collected until the SrO2 and StO2 values returned to the baseline. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vascular Occlusion Test | The pediatric SomaSensor™ probe of INVOS® and the 15-mm sensor of InSpectra™ are placed on each thenar muscle in the same subject. The side on which the probe will be placed is randomly determined. INVOS® updates data every 5 s and data (SrO2) will be manually recorded. The data of InSpectra™ (StO2) are automatically collected and sampled every 2 s. Vascular occlusion test (VOT) is done as follows:Adult-size blood pressure cuffs are placed around each upper arm. The both cuffs are simultaneously inflated to 30 mmHg above the initial systolic blood pressure and kept inflated until the SrO2 or StO2 decreased to 40%. When the value reaches 40% or just below it, the cuff on the same side is deflated rapidly. The data will be collected until the SrO2 and StO2 values returned to the baseline. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change of Tissue Oxygenation Value During Ischemia and Reperfusion Period Until Basline Value Was Achieved | During vascular occlusion test, the changes of StO2 and SrO2 values can divided into 3 epoch; Desaturation, Reoxygenation and Reactive hyperemia. After data collection, the rate of desaturation and reoxygenation were calculated. | Posted | Mean | Standard Deviation | %/min | Until basline tissue oxygenation value was achieved |
|
up to 1 days after study
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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 | Vascular Occlusion Test | The pediatric SomaSensor™ probe of INVOS® and the 15-mm sensor of InSpectra™ are placed on each thenar muscle in the same subject. The side on which the probe will be placed is randomly determined. INVOS® updates data every 5 s and data (SrO2) will be manually recorded. The data of InSpectra™ (StO2) are automatically collected and sampled every 2 s. Vascular occlusion test (VOT) is done as follows:Adult-size blood pressure cuffs are placed around each upper arm. The both cuffs are simultaneously inflated to 30 mmHg above the initial systolic blood pressure and kept inflated until the SrO2 or StO2 decreased to 40%. When the value reaches 40% or just below it, the cuff on the same side is deflated rapidly. The data will be collected until the SrO2 and StO2 values returned to the baseline. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jin-Tae Kim | Seoul National University Hospital | 82-10-6260-8490 | jintae73@gmail.com |
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| ID | Term |
|---|---|
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| vascular occlusion test | Device | Using Inspectra™ probe attacted to another thenar muscle, tissue oxgyenation is measured by VOT. |
|
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Baseline, Miminum and Maximum Tissue Oxygenation Value Measured by INVOS® (SrO2) Until Basline Value Was Achieved | Before VOT. basline StO2 and SrO2 were recorded and compared each other. During VOT, minimum/maximum StO2 and SrO2 were also recorded and compared each other. | Posted | Mean | Standard Deviation | percentage of oxyhemoglobin | Until basline tissue oxygenation value was achieved |
|
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| Primary | Sum of Tissue Oxygenation Value Which Above Basline Value After Reperfusion Period Until Basline Value Was Achieved | During vascular occlusion test, the changes of StO2 and SrO2 values can divided into 3 epoch; Desaturation, Reoxygenation and Reactive hyperemia. After data collection, the rate of desaturation and reoxygenation were calculated. | Posted | Mean | Standard Deviation | %*min | Until basline tissue oxygenation value was achieved |
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| 0 |
| 20 |
| 0 |
| 20 |
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| maximum value during VOT |
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