Healthy
Conditions
Keywords
Measures, near-Infrared spectroscopy, ischemia, reperfusion
Brief summary
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™.
Detailed description
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.
Interventions
DEVICEvascular occlusion test
Using Invos® probe attacted to one thenar muscle, tissue oxgyenation is measured by VOT.
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
26 Years to 41 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy subject
Exclusion criteria
* age under 18 years old * with arteriovenous fistula * with peripheral vessel disease * taking vasoactive drug * with a skin ailment * with HTN, DM * with diagnosed heart disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Tissue Oxygenation Value During Ischemia and Reperfusion Period Until Basline Value Was Achieved | Until basline tissue oxygenation 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. |
| Sum of Tissue Oxygenation Value Which Above Basline Value After Reperfusion Period Until Basline Value Was Achieved | Until basline tissue oxygenation 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline, Miminum and Maximum Tissue Oxygenation Value Measured by INVOS® (SrO2) Until Basline Value Was Achieved | Until basline tissue oxygenation 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Vascular Occlusion Test |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 33 years STANDARD_DEVIATION 5 |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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.
Time frame: Until basline tissue oxygenation value was achieved
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INVOS® | Change of Tissue Oxygenation Value During Ischemia and Reperfusion Period Until Basline Value Was Achieved | Desaturation rate | 17.9 %/min | Standard Deviation 2.3 |
| INVOS® | Change of Tissue Oxygenation Value During Ischemia and Reperfusion Period Until Basline Value Was Achieved | Reoxygenation rate | 280.0 %/min | Standard Deviation 57.5 |
| InSpectra™ | Change of Tissue Oxygenation Value During Ischemia and Reperfusion Period Until Basline Value Was Achieved | Desaturation rate | 13.5 %/min | Standard Deviation 2.1 |
| InSpectra™ | Change of Tissue Oxygenation Value During Ischemia and Reperfusion Period Until Basline Value Was Achieved | Reoxygenation rate | 186.5 %/min | Standard Deviation 39.7 |
Comparison: Unpaired t-test was used to compare the difference between SrO2 and StO2.p-value: <0.05t-test, 1 sided
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.
Time frame: Until basline tissue oxygenation value was achieved
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INVOS® | Sum of Tissue Oxygenation Value Which Above Basline Value After Reperfusion Period Until Basline Value Was Achieved | 23.5 %*min | Standard Deviation 9.6 |
| InSpectra™ | Sum of Tissue Oxygenation Value Which Above Basline Value After Reperfusion Period Until Basline Value Was Achieved | 16.4 %*min | Standard Deviation 6.3 |
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.
Time frame: Until basline tissue oxygenation value was achieved
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INVOS® | Baseline, Miminum and Maximum Tissue Oxygenation Value Measured by INVOS® (SrO2) Until Basline Value Was Achieved | baseline value before VOT | 75.6 percentage of oxyhemoglobin | Standard Deviation 8.2 |
| INVOS® | Baseline, Miminum and Maximum Tissue Oxygenation Value Measured by INVOS® (SrO2) Until Basline Value Was Achieved | minimum value during VOT | 39.6 percentage of oxyhemoglobin | Standard Deviation 0.5 |
| INVOS® | Baseline, Miminum and Maximum Tissue Oxygenation Value Measured by INVOS® (SrO2) Until Basline Value Was Achieved | maximum value during VOT | 95.1 percentage of oxyhemoglobin | Standard Deviation 0.2 |
| InSpectra™ | Baseline, Miminum and Maximum Tissue Oxygenation Value Measured by INVOS® (SrO2) Until Basline Value Was Achieved | baseline value before VOT | 81.8 percentage of oxyhemoglobin | Standard Deviation 3.4 |
| InSpectra™ | Baseline, Miminum and Maximum Tissue Oxygenation Value Measured by INVOS® (SrO2) Until Basline Value Was Achieved | minimum value during VOT | 40.2 percentage of oxyhemoglobin | Standard Deviation 0.4 |
| InSpectra™ | Baseline, Miminum and Maximum Tissue Oxygenation Value Measured by INVOS® (SrO2) Until Basline Value Was Achieved | maximum value during VOT | 94.6 percentage of oxyhemoglobin | Standard Deviation 1.7 |