Comparison of Change of Tissue Oxygenation During a Vascular Occlusion Test Using Two Different NIRS (O3TM vs. INVOS®)

Comparison of Change of Tissue Oxygenation During a Vascular Occlusion Test Using Two Different Near-infrared Spectroscopy (O3TM vs. INVOS®)

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

Study Overview

• Status: Completed
• Conditions: Tissue Oxygen Saturation
• Intervention / Treatment: Device: O3

Detailed Description

Near-infrared spectroscopy (NIRS) has been used to measure regional hemoglobin oxygen saturation of tissue. Recently, it also has been used to monitor peripheral tissue oxygen saturation, and micro-vascular reactivity using vascular occlusion test (VOT).

O3 TM is recently developed NIRS and there are only two clinical trials using this device, until now. In one study, this device could adequately predict cerebral regional oxygen saturation. And in the other study, peripheral tissue oxygenation was measured during ischemic pre-conditioning in heart surgery and it showed correlation between O3 TM and other NIRS ( EQUANOX) which has been used to monitor peripheral tissue oxygenation. But in this study, study group was patient with heart disease and the deoxygenation and reoxygenation rate during VOT was not not measured, which reflects tissue oxygen extraction and micro-vascular reactivity.

In NIRS devices, there are assumed cerebral arterial-venous ratio upon which oximetry values are calculated. In INVOS®, assumed arterial-venous ratio is 25/75. In other NIRS, assumed arterial-venous ratio is 30/70. But unlike other NIRS, O3 TM can change its preset arterial-venous ratio between 25/75 and 30/70, and there are no studies compare oximetry values between these two different settings.

In this study, the investigators try to compare INVOS®, which has been used widely for monitor tissue oxygenation, and two different settings of O3 TM ( arterial-venous ratio; 30/70 and 25/75). Three probes will be attached at same site simultaneously and the investigators will measure change of tissue oxygenation, deoxygenation rate and reoxygenation rate during vascular occlusion test

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Jongro Gu
    • Seoul, Jongro Gu, Korea, Republic of, 15710
      • SNUH
  • Soul-t'ukpyolsi
    • Seoul, Soul-t'ukpyolsi, Korea, Republic of, 03080
      • Hee-Soo Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adult without known disease

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: O3 monitor; tissue oxygenation comparison of O3 & INVOS	Device: O3; O3 TM and INVOS® monitoring simultaneously in single patient during 3 min of vascular occlusion test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
deoxygenation rate (%/min)	deoxygenation rate during vascular occlusion	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)	reoxygenation rate after reperfusion	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)	area under curve value of hyperemic area above baseline tissue oxygenation after reperfusion	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)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): October 29, 2018
• Study Completion (Actual): November 20, 2018

Study Registration Dates

• First Submitted: December 24, 2017
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (Actual): January 10, 2018

Study Record Updates

• Last Update Posted (Actual): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 7, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1712-054-905

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No