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

NCT ID: NCT01848977

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-04-30

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

vascular occlusion test

Intervention Type: DEVICE

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

vascular occlusion test

Intervention Type: DEVICE

Using Inspectra™ probe attacted to another thenar muscle, tissue oxgyenation is measured by VOT.

Interventions

vascular occlusion test

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

Intervention Type: DEVICE

vascular occlusion test

Using Inspectra™ probe attacted to another thenar muscle, tissue oxgyenation is measured by VOT.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 26 Years
• Maximum Eligible Age: 41 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin-Tae Kim

Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin-Tae Kim, Ph.D.

Role: STUDY_DIRECTOR

Seoul National University Hospital

Other Identifiers

H-1302-016-462

Identifier Type: -

Identifier Source: org_study_id