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OpenTrials
Completed

NCT Number: NCT01848977

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

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™.

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Key information

Conditions

Healthy Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

26 year–41 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vascular occlusion test

Device

Using Invos® probe attacted to one thenar muscle, tissue oxgyenation is measured by VOT.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 8, 2013
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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