NCT03535623

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

May 29, 2018

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2024

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

June 11, 2026

Completed
Last Updated

June 11, 2026

Status Verified

May 1, 2026

Enrollment Period

5.8 years

First QC Date

May 14, 2018

Results QC Date

July 23, 2024

Last Update Submit

May 18, 2026

Conditions

Ischemic Reperfusion InjuryOther Reconstructive SurgeryRadiotherapy

Keywords

remote ischemic preconditioningfree flap reconstructionpreoperative radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Tissue Oxygen Saturation

    tissue oxygen saturation of the flap

    postoperative day 1

Secondary Outcomes (1)

  • Number of Participants With Flap Complications

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

Study Arms (2)

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.

Other: remote ischemic preconditioning (RIPC)

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.

Other: Sham-RIPC

Interventions

Sham-RIPCOTHER

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

Sham-RIPC
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.

RIPC

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult head and neck cancer patients undergoing free flap reconstructive surgery with preoperative radiotherapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 40846225DERIVED

Results Point of Contact

Title
Dr Youn Joung Cho, MD, PhD
Organization
Seoul National University Hospital
mingming7@gmail.com
82-2-2072-2467

Study Officials

  • Youn Joung Cho, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

May 14, 2018

First Posted

May 24, 2018

Study Start

May 29, 2018

Primary Completion

March 20, 2024

Study Completion

April 18, 2024

Last Updated

June 11, 2026

Results First Posted

June 11, 2026

Record last verified: 2026-05

Locations

KR(1)