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

• ClinicalTrials.gov Identifier: NCT03395834
• Recruitment Status: Completed
• First Posted: January 10, 2018
• Last Update Posted: July 9, 2019
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Hee-Soo Kim, Seoul National University Hospital

Study Description

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

Condition or disease	Intervention/treatment	Phase
Tissue Oxygen Saturation	Device: O3	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Comparison of Change of Tissue Oxygenation During a Vascular Occlusion Test Using Two Different Near-infrared Spectroscopy (O3TM vs. INVOS®)
• Actual Study Start Date: February 1, 2018
• Actual Primary Completion Date: October 29, 2018
• Actual Study Completion Date: November 20, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change of tissue oxygenation during vascular occlusion test [ Time Frame: 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) ]
   Change of tissue oxygenation measured by O3 (25/75), O3 (30/70) and INVOS® during vascular occlusion test

Secondary Outcome Measures :

1. deoxygenation rate (%/min) [ Time Frame: 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) ]
   deoxygenation rate during vascular occlusion
2. reoxygenation rate (%/min) [ Time Frame: 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 after reperfusion
3. Area under curve value of hyperemic area (% min) [ Time Frame: 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 above baseline tissue oxygenation after reperfusion

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Korea, Republic of

SNUH

Seoul, Jongro Gu, Korea, Republic of, 15710

Hee-Soo Kim

Seoul, Soul-t'ukpyolsi, Korea, Republic of, 03080

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Seoul National University Hospital

Seoul, Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

Investigators

• Principal Investigator: Hee-Soo Kim; Seoul National University

More Information

• Responsible Party: Hee-Soo Kim, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03395834
• Other Study ID Numbers: 1712-054-905
• First Posted: January 10, 2018
• Last Update Posted: July 9, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No