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Changes in Tissue Microcirculation During Ischemic Conditioning: Pilot Study

Changes in Tissue Microcirculation During Ischemic Conditioning: Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03089814
Enrollment
20
Registered
2017-03-24
Start date
2017-03-23
Completion date
2017-07-10
Last updated
2018-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microcirculation

Keywords

tissue oxygen saturation, ischemic conditioning

Brief summary

Changes in tissue microcirculation during ischemic conditioning (4 cycles of 5-min ischemia and 5-min reperfusion) has not been well documented. In previous studies, there was difference in changes in microcirculation, such as recovery slope and occlusion slope, between healthy subjects and cardiac surgery patients. Moreover, the occlusion slope, which reflects local tissue oxygen consumption during ischemic period, is anticipated to decrease during repeated ischemia-reperfusion cycle by its protecting effect, however there has not been well-conducted study. The purpose of the study is to evaluate the changes in microcirculation measured by tissue oxygen saturation during ischemic conditioning between healthy volunteers and cardiac surgery patients.

Detailed description

Subjects who are male healthy volunteers (aged 20-45) or who are scheduled to receive cardiac surgery (aged 20-80) will undergo ischemic conditioning, consisting of 4 cycles of 5-min ischemia with pressure of 200 mmHg on upper extremity followed by 5-min reperfusion with no pressure. During ischemic conditioning, changes in tissue microcirculation (baseline tissue saturation, occlusion slope during ischemia, and recovery slope during reperfusion) will be observed using tissue oxygen saturation sensor attached to the thenar muscle of the hand. For cardiac surgery patients, the study will be conducted before anesthesia induction on the surgery day to exclude any potential effect of anesthetics.

Interventions

Four cycles of 5-min inflation of pneumatic cuff on upper extremity up to 200 mmHg, followed by 5-min deflation with no pressure.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

\<Healthy volunteers\> Inclusion Criteria: * Age 20-45 * No underlying chronic disease * Male volunteer

Exclusion criteria

* Under taking prescription drugs * Taking herbal medicines within 2 weeks * Baseline systolic blood pressure \> 150 mmHg or diastolic pressure \> 100 mmHg * Body mass index \< 18 kg/m\^2 or \> 30 kg/m\^2 * Vigorous exercise, excessive alcohol, smoking or caffeine within 24 hours * Any abnormalities on upper extremities * Do not consent to participate \<Cardiac surgery patients\> Inclusion Criteria: * Age 20-80 * Scheduled for cardiac surgery

Design outcomes

Primary

MeasureTime frameDescription
Changes in microcirculation during ischemic conditioningDuring 4-cycles of 5-min ischemia followed by 5-min reperfusionChanges in occlusion slope during ischemia and recovery slope during reperfusion

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026