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Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction

Primary Purpose

Remote Ischemic Preconditioning

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
remote ischemic preconditioning (RIPC)
sham-RIPC
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Remote Ischemic Preconditioning focused on measuring remote ischemic preconditioning, free flap reconstruction, tissue oxygen saturation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Remote ischemic preconditioning (RIPC)

Control (Sham-RIPC)

Arm Description

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.

Intervention is Sham-RIPC (ischemia pressure < 10 mmHg) applied to upper arm.

Outcomes

Primary Outcome Measures

tissue oxygen saturation
tissue oxygen saturation of free flap

Secondary Outcome Measures

Full Information

First Posted
March 14, 2018
Last Updated
March 3, 2020
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03474952
Brief Title
Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction
Official Title
Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction in Head and Neck Cancer Patients: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 13, 2018 (Actual)
Primary Completion Date
December 9, 2019 (Actual)
Study Completion Date
December 9, 2019 (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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Remote Ischemic Preconditioning
Keywords
remote ischemic preconditioning, free flap reconstruction, tissue oxygen saturation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RIPC group and control (sham-RIPC) group
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote ischemic preconditioning (RIPC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (Sham-RIPC)
Arm Type
Sham Comparator
Arm Description
Intervention is Sham-RIPC (ischemia pressure < 10 mmHg) applied to upper arm.
Intervention Type
Procedure
Intervention Name(s)
remote ischemic preconditioning (RIPC)
Intervention Description
remote ischemic preconditioning consists of 4 cycles of 5-min ischemia and subsequent 5-min reperfusion using pneumatic cuff applied to upper arm
Intervention Type
Procedure
Intervention Name(s)
sham-RIPC
Intervention Description
ischemia pressure less than 10 mmHg (sham-RIPC)
Primary Outcome Measure Information:
Title
tissue oxygen saturation
Description
tissue oxygen saturation of free flap
Time Frame
postoperative day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youn Joung Cho, 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
Undecided
Citations:
PubMed Identifier
35581399
Citation
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.
Results Reference
derived

Learn more about this trial

Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction

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