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Completed

NCT Number: NCT03474952

Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction

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.

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Key information

Conditions

Remote Ischemic Preconditioning

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 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

remote ischemic preconditioning (RIPC)

Procedure

remote ischemic preconditioning consists of 4 cycles of 5-min ischemia and subsequent 5-min reperfusion using pneumatic cuff applied to upper arm

Sham-RIPC

Procedure

ischemia pressure less than 10 mmHg (sham-RIPC)

Primary outcomes

  1. tissue oxygen saturation

    Time frame: postoperative day 1

    tissue oxygen saturation of free flap

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: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 23, 2018
Registry last updated
Mar 4, 2020

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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