Ischemic Reperfusion Injury, Other Reconstructive Surgery, Radiotherapy
Conditions
Keywords
remote ischemic preconditioning, free flap reconstruction, preoperative radiotherapy
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.
Interventions
OTHERremote ischemic preconditioning (RIPC)
RIPC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion.
OTHERSham-RIPC
Sham-RIPC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of \< 10 mmHg and 5-min reperfusion.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tissue Oxygen Saturation | postoperative day 1 | tissue oxygen saturation of the flap |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Flap Complications | during the study period until discharge, an average of 17.5 days | Number of participants who occurred flap complications during the study period |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORYoun Joung Cho, MD
Seoul National University Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 65 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 19 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Regional tissue oxygen saturation | 85 % |
| Region of Enrollment South Korea | 39 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 0 / 20 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 |
Outcome results
None listed