Comparison of Two Devices Using Near-infra Red Spectroscopy During a Vascular Occlusion Test

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: vascular occlusion test

• Registration Number: NCT01848977
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2013-04-07
• Study First Submitted QC: 2013-05-03
• Study First Posted: 2013-05-08
• Results First Submitted: 2014-12-02
• Status Verified: 2015-01
• Results First Submitted QC: 2015-01-09
• Last Update Submitted: 2015-01-09
• Results First Posted: 2015-01-26
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• healthy subject

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vascular occlusion test	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.