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Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03474952
Recruitment Status : Completed
First Posted : March 23, 2018
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Youn Joung Cho, MD, Seoul National University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Remote Ischemic Preconditioning Procedure: remote ischemic preconditioning (RIPC) Procedure: sham-RIPC Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RIPC group and control (sham-RIPC) group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction in Head and Neck Cancer Patients: a Randomized Controlled Trial
Actual Study Start Date : April 13, 2018
Actual Primary Completion Date : December 9, 2019
Actual Study Completion Date : December 9, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. tissue oxygen saturation [ Time Frame: postoperative day 1 ]
    tissue oxygen saturation of free flap


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474952


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Youn Joung Cho, MD, PhD Seoul National University Hospital
More Information
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Responsible Party: Youn Joung Cho, MD, Clinical assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03474952    
Other Study ID Numbers: RIPC during free flap
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Youn Joung Cho, MD, Seoul National University Hospital:
remote ischemic preconditioning
free flap reconstruction
tissue oxygen saturation
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes