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

• ClinicalTrials.gov Identifier: NCT01848977
• Recruitment Status: Completed
• First Posted: May 8, 2013
• Results First Posted: January 26, 2015
• Last Update Posted: January 26, 2015
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Jin-Tae Kim, Seoul National University Hospital

Study Description

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™.

Condition or disease	Intervention/treatment	Phase
Healthy	Device: vascular occlusion test	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• 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

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 26 Years to 41 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Seoul National University Hospital

Investigators

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

More Information

• Responsible Party: Jin-Tae Kim, Ph.D., Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT01848977
• Other Study ID Numbers: H-1302-016-462
• First Posted: May 8, 2013
• Results First Posted: January 26, 2015
• Last Update Posted: January 26, 2015
• Last Verified: January 2015

Keywords provided by Jin-Tae Kim, Seoul National University Hospital:

Measures; near-Infrared spectroscopy; ischemia; reperfusion