Back to resultsChanges in Tissue Microcirculation During Ischemic Conditioning: Pilot Study
Primary Purpose
Microcirculation
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ischemic conditioning
Sponsored by
About this trial
This is an interventional diagnostic trial for Microcirculation focused on measuring tissue oxygen saturation, ischemic conditioning
Eligibility 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
Exclusion Criteria:
- 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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Healthy volunteers
Cardiac surgery patients
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Changes in microcirculation during ischemic conditioning
Changes in occlusion slope during ischemia and recovery slope during reperfusion
Secondary Outcome Measures
Full Information
NCT ID
NCT03089814
First Posted
March 14, 2017
Last Updated
February 26, 2018
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03089814
Brief Title
Changes in Tissue Microcirculation During Ischemic Conditioning: Pilot Study
Official Title
Changes in Tissue Microcirculation During Ischemic Conditioning: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 23, 2017 (Actual)
Primary Completion Date
July 10, 2017 (Actual)
Study Completion Date
July 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microcirculation
Keywords
tissue oxygen saturation, ischemic conditioning
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cardiac surgery patients
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
ischemic conditioning
Intervention Description
Four cycles of 5-min inflation of pneumatic cuff on upper extremity up to 200 mmHg, followed by 5-min deflation with no pressure.
Primary Outcome Measure Information:
Title
Changes in microcirculation during ischemic conditioning
Description
Changes in occlusion slope during ischemia and recovery slope during reperfusion
Time Frame
During 4-cycles of 5-min ischemia followed by 5-min reperfusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunseok Jeon, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Changes in Tissue Microcirculation During Ischemic Conditioning: Pilot Study
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