Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction in Head and Neck Cancer Patients With Preoperative Radiotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- tissue oxygen saturation
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: remote ischemic preconditioning (RIPC) (Other)
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.
Intervention: Sham-RIPC (Other)
Outcomes
Primary Outcomes
tissue oxygen saturation
Time Frame: postoperative day 1
tissue oxygen saturation of the flap
Secondary Outcomes
- skin temperature(postoperative day 1)
Investigators
Youn Joung Cho, MD, PhD
Clinical assistant professor
Seoul National University Hospital