Comparison of Change of Tissue Oxygenation During a Vascular Occlusion Test Using Two Different NIRS (O3TM vs. INVOS®)
1 other identifier
interventional
20
1 country
4
Brief Summary
This study evaluates the change of tissue oxygenation during a vascular occlusion test using two NIRS ( O3TM and INVOS®). NIRS probe will be attached on volunteer's forearm during vascular occlusion test and tissue oxygenation change will be recorded
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2018
Shorter than P25 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2017
CompletedFirst Posted
Study publicly available on registry
January 10, 2018
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2018
CompletedJuly 9, 2019
July 1, 2019
9 months
December 24, 2017
July 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change of tissue oxygenation during vascular occlusion test
Change of tissue oxygenation measured by O3 (25/75), O3 (30/70) and INVOS® during vascular occlusion test
stable baseline tissue oxygenation saturation ( less than 5 minutes) - 3 minute of vascular occlusion test - stable tissue oxygen saturation after reperfusion (less than 5 minutes)
Secondary Outcomes (3)
deoxygenation rate (%/min)
stable baseline tissue oxygenation saturation ( less than 5 minutes) - 3 minute of vascular occlusion test - stable tissue oxygen saturation after reperfusion (less than 5 minutes)
reoxygenation rate (%/min)
stable baseline tissue oxygenation saturation ( less than 5 minutes) - 3 minute of vascular occlusion test - stable tissue oxygen saturation after reperfusion (less than 5 minutes)
Area under curve value of hyperemic area (% min)
stable baseline tissue oxygenation saturation ( less than 5 minutes) - 3 minute of vascular occlusion test - stable tissue oxygen saturation after reperfusion (less than 5 minutes)
Study Arms (1)
O3 monitor
EXPERIMENTALtissue oxygenation comparison of O3 \& INVOS
Interventions
O3 TM and INVOS® monitoring simultaneously in single patient during 3 min of vascular occlusion test
Eligibility Criteria
You may qualify if:
- Healthy adult without known disease
You may not qualify if:
- Patients with previously known cardio-vascular disease
- Patients with body mass index \>30kg/m2
- Patients on vasoactive drug
- Patients with skin pigmentation on probe attachment site
- Patients who is pregnant
- Patients with chronic anemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
SNUH
Seoul, Jongro Gu, 15710, South Korea
Hee-Soo Kim
Seoul, Soul-t'ukpyolsi, 03080, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Seoul National University Hospital
Seoul, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Hee-Soo Kim
Seoul National University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 24, 2017
First Posted
January 10, 2018
Study Start
February 1, 2018
Primary Completion
October 29, 2018
Study Completion
November 20, 2018
Last Updated
July 9, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share