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

Tissue Oxygen Saturation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03395834
• Other study ID #: 1712-054-905
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: November 20, 2018

Study information

• Verified date: July 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 20, 2018
• Est. primary completion date: October 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Tissue Oxygen Saturation

Intervention

Device:
• O3
O3 TM and INVOS® monitoring simultaneously in single patient during 3 min of vascular occlusion test

Locations

Country	Name	City	State
Korea, Republic of	Hee-Soo Kim	Seoul	Soul-t'ukpyolsi
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	SNUH	Seoul	Jongro Gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)