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

NCT01848977 | Completed Results

• 1 other identifier: H-1302-016-462
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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™.

Conditions

Healthy

Keywords

Measures; near-Infrared spectroscopy; ischemia; reperfusion

Outcome Measures

Primary Outcomes (2)

• Change of Tissue Oxygenation Value During Ischemia and Reperfusion Period Until Basline 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

  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 Outcomes (1)

• Baseline, Miminum and Maximum Tissue Oxygenation Value Measured by INVOS® (SrO2) Until Basline Value Was Achieved

  Until basline tissue oxygenation value was achieved

Study Arms (1)

vascular occlusion test

EXPERIMENTAL

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

Interventions

vascular occlusion test DEVICE

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

vascular occlusion test

Eligibility Criteria

• Age: 26 Years - 41 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy subject

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jin-Tae Kim
• Organization: Seoul National University Hospital

jintae73@gmail.com

82-10-6260-8490

Study Officials

• Jin-Tae Kim, Ph.D.

  Seoul National University Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: April 7, 2013
• First Posted: May 8, 2013
• Study Start: January 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 26, 2015
• Results First Posted: January 26, 2015

Record last verified: 2015-01