Comparison of Two Devices Using Near-infra Red Spectroscopy During a Vascular Occlusion Test
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|ClinicalTrials.gov Identifier: NCT01848977|
Recruitment Status : Completed
First Posted : May 8, 2013
Results First Posted : January 26, 2015
Last Update Posted : January 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Device: vascular occlusion test||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Comparison of Two Devices Using Near-infra Red Spectroscopy for the Measurement of Tissue Oxygenation During a Vascular Occlusion Test (INVOS® Versus Inspectra™)|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Experimental: 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.
Device: vascular occlusion test
Using Invos® probe attacted to one thenar muscle, tissue oxgyenation is measured by VOT.
Device: vascular occlusion test
Using Inspectra™ probe attacted to another thenar muscle, tissue oxgyenation is measured by VOT.
- Change of Tissue Oxygenation Value During Ischemia and Reperfusion Period Until Basline Value Was Achieved [ Time Frame: 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 [ Time Frame: 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.
- Baseline, Miminum and Maximum Tissue Oxygenation Value Measured by INVOS® (SrO2) Until Basline Value Was Achieved [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848977
|Study Director:||Jin-Tae Kim, Ph.D.||Seoul National University Hospital|