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Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction

NCT03474952 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-03-04

No results posted yet for this study

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.

Conditions

  • Remote Ischemic Preconditioning

Interventions

PROCEDURE

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

PROCEDURE

sham-RIPC

ischemia pressure less than 10 mmHg (sham-RIPC)

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Youn Joung Cho, MD, PhD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-13
Primary Completion
2019-12-09
Completion
2019-12-09

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03474952 on ClinicalTrials.gov