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

January 9, 2015 updated by: Jin-Tae Kim, Seoul National University Hospital

Comparison of Two Devices Using Near-infra Red Spectroscopy for the Measurement of Tissue Oxygenation During a Vascular Occlusion Test (INVOS® Versus Inspectra™)

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™.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 41 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Until basline tissue oxygenation value was achieved
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.
Until basline tissue oxygenation value was achieved

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Until basline tissue oxygenation value was achieved

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Director: Jin-Tae Kim, Ph.D., Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

April 7, 2013

First Submitted That Met QC Criteria

May 3, 2013

First Posted (Estimate)

May 8, 2013

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 9, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-1302-016-462

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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