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NCT Number: NCT03395834

Comparison of Change of Tissue Oxygenation During a Vascular Occlusion Test Using Two Different NIRS (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

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Key information

Conditions

Tissue Oxygen Saturation

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SNUH, Seoul, Jongro Gu, South Korea

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

O3

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 10, 2018
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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