Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction
NCT ID: NCT03474952
Last Updated: 2020-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2018-04-13
2019-12-09
Brief Summary
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Detailed Description
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As a sub-study, blood samples will be obtained before and after RIPC/sham-RIPC. From them, plasma dialysate will be prepared to use for Langendorff isolated heart model. Myocardial infarct size of Langendorff rat heart will be compared between the groups to evaluate organ protective effect of RIPC during free flap reconstuctive surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Remote ischemic preconditioning (RIPC)
Intervention is remote ischemic preconditioning (RIPC) consists of 4 cycles of 5-min ischemia (using pneumatic cuff pressure of 200 mmHg) and subsequent 5-min reperfusion applied to upper arm.
remote ischemic preconditioning (RIPC)
remote ischemic preconditioning consists of 4 cycles of 5-min ischemia and subsequent 5-min reperfusion using pneumatic cuff applied to upper arm
Control (Sham-RIPC)
Intervention is Sham-RIPC (ischemia pressure \< 10 mmHg) applied to upper arm.
sham-RIPC
ischemia pressure less than 10 mmHg (sham-RIPC)
Interventions
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remote ischemic preconditioning (RIPC)
remote ischemic preconditioning consists of 4 cycles of 5-min ischemia and subsequent 5-min reperfusion using pneumatic cuff applied to upper arm
sham-RIPC
ischemia pressure less than 10 mmHg (sham-RIPC)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* AV fistula at arm, any reason to protect arm
* vascular abnormality or discomfort at arm
* peripheral vascular disease, peripheral neuropathy, or coagulopathy
* uncontrolled diabetes mellitus
* preoperative use of beta-blocker
* history of radiation therapy
* refuse to enrol
20 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Youn Joung Cho, MD
Clinical assistant professor
Principal Investigators
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Youn Joung Cho, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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Min SH, Choe SH, Kim WS, Ahn SH, Cho YJ. Effects of ischemic conditioning on head and neck free flap oxygenation: a randomized controlled trial. Sci Rep. 2022 May 17;12(1):8130. doi: 10.1038/s41598-022-12374-3.
Other Identifiers
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RIPC during free flap
Identifier Type: -
Identifier Source: org_study_id
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