Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction
1 other identifier
interventional
50
1 country
1
Brief Summary
Remote ischemic preconditioning (RIPC) has been revealed organ-protective effect in many previous clinical settings including coronary intervention or cardiovascular surgery. However its protective role during free flap reconstructive surgery in head and neck cancer patients has not yet been elucidated. The purpose of the current study is to evaluate the effect of RIPC on tissue oxygen saturation and skin temperature of the flap, as well as its organ-protective effect using Langendorff isolated heart ischemia-reperfusion model.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2018
CompletedFirst Posted
Study publicly available on registry
March 23, 2018
CompletedStudy Start
First participant enrolled
April 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2019
CompletedMarch 4, 2020
March 1, 2020
1.7 years
March 14, 2018
March 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
tissue oxygen saturation
tissue oxygen saturation of free flap
postoperative day 1
Study Arms (2)
Remote ischemic preconditioning (RIPC)
EXPERIMENTALIntervention 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.
Control (Sham-RIPC)
SHAM COMPARATORIntervention is Sham-RIPC (ischemia pressure \< 10 mmHg) applied to upper arm.
Interventions
remote ischemic preconditioning consists of 4 cycles of 5-min ischemia and subsequent 5-min reperfusion using pneumatic cuff applied to upper arm
Eligibility Criteria
You may qualify if:
- patients undergoing free flap reconstructive surgery
You may not qualify if:
- BMI \< 18, \> 35 kg/m\^2
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
Related Publications (1)
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.
PMID: 35581399DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Youn Joung Cho, MD, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical assistant professor
Study Record Dates
First Submitted
March 14, 2018
First Posted
March 23, 2018
Study Start
April 13, 2018
Primary Completion
December 9, 2019
Study Completion
December 9, 2019
Last Updated
March 4, 2020
Record last verified: 2020-03