Changes in Tissue Microcirculation During Ischemic Conditioning: Pilot Study

NCT ID: NCT03089814

Last Updated: 2018-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-23
• Study Completion Date: 2017-07-10

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.

Conditions

Microcirculation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Healthy volunteers

Healthy male volunteers will receive ischemic conditioning (4 cycles of 5-min ischemia followed by 5-min reperfusion on upper extremity) while measuring changes in tissue microcirculation at the thenar muscle.

Group Type: ACTIVE_COMPARATOR

ischemic conditioning

Intervention Type: PROCEDURE

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

Cardiac surgery patients

Patients scheduled for cardiac surgery will receive ischemic conditioning (4 cycles of 5-min ischemia followed by 5-min reperfusion on upper extremity) while measuring changes in tissue microcirculation at the thenar muscle.

Group Type: ACTIVE_COMPARATOR

ischemic conditioning

Intervention Type: PROCEDURE

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

Interventions

ischemic conditioning

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age 20-45
• No underlying chronic disease
• Male volunteer

• Age 20-80
• Scheduled for cardiac surgery

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>

• Baseline systolic blood pressure > 150 mmHg or diastolic pressure > 100 mmHg
• Body mass index < 18 kg/m^2 or > 30 kg/m^2
• Uncontrolled diabetes
• Under taking beta-blockers
• Severe renal dysfunction, chronic kidney disease, on hemodialysis
• Any abnormalities on upper extremities (i.e, AV fistula on arms)
• Peripheral vascular disease, peripheral neuropathy, coagulopathy
• Vigorous exercise, excessive alcohol, smoking or caffeine within 24 hours
• Pregnant
• Emergency surgery
• Do not consent to participate

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yunseok Jeon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yunseok Jeon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

RIPC-VOT

Identifier Type: -

Identifier Source: org_study_id