RIPC During Free Flap With Preoperative Radiotherapy

Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction in Head and Neck Cancer Patients With Preoperative Radiotherapy

Remote ischemic preconditioning (RIPC) has shown organ-protective effects in many clinical settings including patients with ischemic heart disease. However its protective role in head and neck cancer patients with preoperative radiotherapy undergoing free flap reconstructive surgery has not yet been evaluated. 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 effects using Langendorff isolated heart ischemia-reperfusion model.

Study Overview

• Status: Completed
• Conditions: Ischemic Reperfusion Injury; Radiotherapy; Other Reconstructive Surgery
• Intervention / Treatment: Other: remote ischemic preconditioning (RIPC); Other: Sham-RIPC

Detailed Description

Patients undergoing free flap reconstructive surgery for head and neck cancer with preoperative radiotherapy 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 the 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 effects of RIPC during free flap reconstructive surgery.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Youn Joung Cho, MD; Phone Number: 82-2-2072-2467; Email: mingming7@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult head and neck cancer patients undergoing free flap reconstructive surgery with preoperative radiotherapy

Exclusion Criteria:

• Radiotherapy within 4 weeks
• Body mass index < 18 kg/m^2 or > 35 kg/m^2
• Presence of AV fistula at the arm, any reason to protect arms
• Presence of vascular abnormality or discomfort at arms
• Peripheral vascular disease, peripheral neuropathy, or coagulopathy
• Uncontrolled diabetes mellitus
• Preoperative use of beta-blockers
• Refuse to enrol

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RIPC; Remote ischemic preconditioning (RIPC) consisted of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion is applied to the upper arm of the patients in the RIPC group.	Other: remote ischemic preconditioning (RIPC); RIPC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion.
Sham Comparator: Sham-RIPC; Sham-RIPC consisted of 4 cycles of 5-min ischemia using pneumatic cuff pressure of < 10 mmHg and 5-min reperfusion is applied to the upper arm of the patients in the Sham-RIPC group.	Other: Sham-RIPC; Sham-RIPC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of < 10 mmHg and 5-min reperfusion.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
skin temperature	skin temperature of the flap and the adjacent tissue	postoperative day 1
myocardial infarct size of the rat Langendorff model	myocardial infarct size of the rat Langendorff model	24 hr

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2018
• Primary Completion (Actual): March 20, 2024
• Study Completion (Actual): April 18, 2024

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: remote ischemic preconditioning; free flap reconstruction; preoperative radiotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Ischemia; Reperfusion Injury
• Other Study ID Numbers: RIPC during FF with RT

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