RIPC During Free Flap With Preoperative Radiotherapy

Seoul National University

Status: Completed

Conditions: Other Reconstructive Surgery; Radiotherapy; Ischemic Reperfusion Injury

Treatments: Other: remote ischemic preconditioning (RIPC); Other: Sham-RIPC

Study type: Interventional

Funder types: Other

Identifiers

NCT03535623

RIPC during FF with RT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

44 participants in 2 patient groups

RIPC

Experimental group

Description:

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.

Treatment:

Other: remote ischemic preconditioning (RIPC)

Sham-RIPC

Sham Comparator group

Description:

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.

Treatment:

Other: Sham-RIPC