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Completed

NCT Number: NCT03535623

RIPC During Free Flap With Preoperative Radiotherapy

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.

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Key information

Conditions

Ischemic Reperfusion Injury Other Reconstructive Surgery Radiotherapy

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sham-RIPC

Other

Sham-RIPC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of < 10 mmHg and 5-min reperfusion.

Primary outcomes

  1. Tissue Oxygen Saturation

    Time frame: postoperative day 1

    tissue oxygen saturation of the flap

Secondary outcomes

  1. Number of Participants With Flap Complications

    Time frame: during the study period until discharge, an average of 17.5 days

    Number of participants who occurred flap complications during the study period

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction in Head and Neck Cancer Patients With Preoperative Radiotherapy

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
May 24, 2018
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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