RIPC During Free Flap With Preoperative Radiotherapy

Not Applicable

Completed

• Conditions: Ischemic Reperfusion Injury; Other Reconstructive Surgery; Radiotherapy
• Interventions: Other: remote ischemic preconditioning (RIPC); Other: Sham-RIPC

• Registration Number: NCT03535623
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2018-05-14
• Study First Submitted QC: 2018-05-14
• Study First Posted: 2018-05-24
• Study Start: 2018-05-29
• Primary Completion: 2024-03-20
• Study Completion: 2024-04-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-04
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIPC	remote ischemic preconditioning (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.
Sham-RIPC	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
skin temperature	postoperative day 1	skin temperature of the flap and the adjacent tissue

Trial Locations

Locations (1)

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