Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction

Not Applicable

Completed

• Conditions: Remote Ischemic Preconditioning
• Interventions: Procedure: sham-RIPC; Procedure: remote ischemic preconditioning (RIPC)

• Registration Number: NCT03474952
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-21
• Study First Posted: 2018-03-23
• Study Start: 2018-04-13
• Primary Completion: 2019-12-09
• Study Completion: 2019-12-09
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-03
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control (Sham-RIPC)	sham-RIPC	Intervention is Sham-RIPC (ischemia pressure \< 10 mmHg) applied to upper arm.
Remote ischemic preconditioning (RIPC)	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.

Primary Outcome Measures

Name	Time	Method
tissue oxygen saturation	postoperative day 1	tissue oxygen saturation of free flap

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of