Remote Ischemic Preconditioning
Conditions
Keywords
remote ischemic preconditioning, free flap reconstruction, tissue oxygen saturation
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.
Interventions
PROCEDUREremote ischemic preconditioning (RIPC)
remote ischemic preconditioning consists of 4 cycles of 5-min ischemia and subsequent 5-min reperfusion using pneumatic cuff applied to upper arm
PROCEDUREsham-RIPC
ischemia pressure less than 10 mmHg (sham-RIPC)
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
RIPC group and control (sham-RIPC) group
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tissue oxygen saturation | postoperative day 1 | tissue oxygen saturation of free flap |
Countries
South Korea
Outcome results
None listed