Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction

March 3, 2020 updated by: Youn Joung Cho, MD, Seoul National University Hospital

Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction in Head and Neck Cancer Patients: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing free flap reconstructive surgery for head and neck cancer will be randomized to either remote ischemic preconditioning (RIPC) group or control group. On the day of surgery, after induction of anesthesia, RIPC, consisting of 4 cycles of 5-min ischemia (using pneumatic cuff pressure of 200 mmHg) followed by 5-min reperfusion at upper arm, or sham-RIPC (pressure < 10 mmHg) will be induced in the RIPC or control group, respectively. Before completion of surgery, RIPC or sham-RIPC will be repeated. Tissue oxygen saturation and skin temperature of the flap will be recorded until postoperative day 1.

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing free flap reconstructive surgery

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Sham Comparator: Control (Sham-RIPC)
Intervention is Sham-RIPC (ischemia pressure < 10 mmHg) applied to upper arm.
Procedure: sham-RIPC
ischemia pressure less than 10 mmHg (sham-RIPC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tissue oxygen saturation
Time Frame: postoperative day 1
tissue oxygen saturation of free flap
postoperative day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Youn Joung Cho, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2018

Primary Completion (Actual)

December 9, 2019

Study Completion (Actual)

December 9, 2019

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

March 21, 2018

First Posted (Actual)

March 23, 2018

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIPC during free flap

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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