Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Remote Ischemic Preconditioning

Intervention / Treatment
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* Procedure: remote ischemic preconditioning (RIPC)
* Procedure: sham-RIPC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RIPC group and control (sham-RIPC) group
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote ischemic preconditioning (RIPC)<br>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)<br>* remote ischemic preconditioning consists of 4 cycles of 5-min ischemia and subsequent 5-min reperfusion using pneumatic cuff applied to upper arm<br>|
| Sham Comparator: Control (Sham-RIPC)<br>Intervention is Sham-RIPC (ischemia pressure < 10 mmHg) applied to upper arm. | Procedure: sham-RIPC<br>* ischemia pressure less than 10 mmHg (sham-RIPC)<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remote ischemic preconditioning, free flap reconstruction, tissue oxygen saturation