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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIPC | Experimental | 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 Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remote ischemic preconditioning (RIPC) | Other | RIPC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tissue Oxygen Saturation | tissue oxygen saturation of the flap | postoperative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Flap Complications | Number of participants who occurred flap complications during the study period | during the study period until discharge, an average of 17.5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Youn Joung Cho, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40846225 | Derived | Min S, Kim JE, Oh HM, Yoon SB, Ahn SH, Cho YJ. Effects of Remote Ischemic Conditioning on Flap Oxygenation in Patients Undergoing Head and Neck Reconstruction and Preoperative Radiotherapy: A Randomized Clinical Trial. J Oral Maxillofac Surg. 2025 Nov;83(11):1421-1430. doi: 10.1016/j.joms.2025.07.010. Epub 2025 Aug 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Remote Ischemic Conditioning | Remote ischemic conditioning (RIC) 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. remote ischemic conditioning (RIC): RIC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion. |
| FG001 | Sham | Sham-RIC 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. Sham-RIC: Sham-RIC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of < 10 mmHg and 5-min reperfusion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Remote Ischemic Conditioning | Remote ischemic conditioning (RIC) 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. remote ischemic conditioning (RIC): RIC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tissue Oxygen Saturation | tissue oxygen saturation of the flap | Posted | Median | Inter-Quartile Range | percent | postoperative day 1 |
|
through study completion, an average of 17.5 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Remote Ischemic Conditioning | Remote ischemic conditioning (RIC) 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. remote ischemic conditioning (RIC): RIC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Youn Joung Cho, MD, PhD | Seoul National University Hospital | 82-2-2072-2467 | mingming7@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 9, 2026 | Feb 9, 2026 | Prot_SAP_000.pdf |
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| Sham-RIPC | Other | Sham-RIPC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of < 10 mmHg and 5-min reperfusion. |
|
| BG001 | Sham | Sham-RIC 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. Sham-RIC: Sham-RIC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of < 10 mmHg and 5-min reperfusion. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Regional tissue oxygen saturation | Baseline values of tissue oxygen saturation before any intervention in the two groups. | Median | Inter-Quartile Range | % |
|
|
|
| Secondary | Number of Participants With Flap Complications | Number of participants who occurred flap complications during the study period | Posted | Count of Participants | Participants | during the study period until discharge, an average of 17.5 days |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Sham | Sham-RIC 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. Sham-RIC: Sham-RIC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of < 10 mmHg and 5-min reperfusion. | 0 | 19 | 0 | 19 | 0 | 19 |
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