Clinical trial NCT03395834: Comparison of Change of Tissue Oxygenation During a Vascular Occlusion Test Using Two Different NIRS (O3TM vs. INVOS®)
Official title: Comparison of Change of Tissue Oxygenation During a Vascular Occlusion Test Using Two Different Near-infrared Spectroscopy (O3TM vs. INVOS®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tissue Oxygen Saturation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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

Eligibility 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

Primary outcomes:
measure: Change of tissue oxygenation during vascular occlusion test
timeFrame: 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:
measure: deoxygenation rate (%/min)
timeFrame: 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)
measure: reoxygenation rate (%/min)
timeFrame: 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)
measure: Area under curve value of hyperemic area (% min)
timeFrame: 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)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNUH
state: Jongro Gu
city: Seoul
country: Korea, Republic of
facility: Hee-Soo Kim
state: Soul-t'ukpyolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University
name: Hee-Soo Kim
role: PRINCIPAL_INVESTIGATOR
References: