Clinical trial · Interventional
Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction
Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction in Head and Neck Cancer Patients: a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Remote Ischemic Preconditioning | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| remote ischemic preconditioning (RIPC) | Procedure | — | UNRESOLVED |
| sham-RIPC | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Remote ischemic preconditioning (RIPC)
- description
- Intervention is remote ischemic preconditioning (RIPC) consists of 4 cycles of 5-min ischemia (using pneumatic cuff pressure of 200 mmHg) and subsequent 5-min reperfusion applied to upper arm.
- interventionNames
- Procedure: remote ischemic preconditioning (RIPC)
- type
- SHAM_COMPARATOR
- label
- Control (Sham-RIPC)
- description
- Intervention is Sham-RIPC (ischemia pressure \< 10 mmHg) applied to upper arm.
- interventionNames
- Procedure: sham-RIPC
Primary outcomes (1)
- measure
- tissue oxygen saturation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMin SH, Choe SH, Kim WS, Ahn SH, Cho YJ. Effects of ischemic conditioning on head and neck free flap oxygenation: a randomized controlled trial. Sci Rep. 2022 May 17;12(1):8130. doi: 10.1038/s41598-022-12374-3. PMID 35581399