N/A
N=20
Comparison of Two Devices Using Near-infra Red Spectroscopy During a Vascular Occlusion Test
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01848977 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Change of Tissue Oxygenation Value During Ischemia and Reperfusion Period Until Basline Value Was Achieved — 17.9; 13.5; 280.0; 186.5 %/min — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- vascular occlusion test (Device)
- Age
- Adult · 26+ yrs
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Tissue Oxygenation Value During Ischemia and Reperfusion Period Until Basline Value Was Achieved |
17.9; 13.5; 280.0; 186.5 | <0.05 sig |
| PRIMARY Sum of Tissue Oxygenation Value Which Above Basline Value After Reperfusion Period Until Basline Value Was Achieved |
23.5; 16.4 | — |
| SECONDARY Baseline, Miminum and Maximum Tissue Oxygenation Value Measured by INVOS® (SrO2) Until Basline Value Was Achieved |
75.6; 81.8; 39.6; 40.2; 95.1; 94.6 | — |
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™.
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
Data sourced from ClinicalTrials.gov (NCT01848977). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.