RIPC During Free Flap With Preoperative Radiotherapy

NCT03535623 | Completed DMC

• 1 other identifier: RIPC during FF with RT
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Reperfusion Injury; Other Reconstructive Surgery; Radiotherapy

Keywords

remote ischemic preconditioning; free flap reconstruction; preoperative radiotherapy

Outcome Measures

Primary Outcomes (1)

• tissue oxygen saturation

  tissue oxygen saturation of the flap

  postoperative day 1

Secondary Outcomes (1)

• skin temperature

  postoperative day 1

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

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

Sham-RIPC OTHER

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

Sham-RIPC

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Study Officials

• Youn Joung Cho, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

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: May 7, 2024

Record last verified: 2024-05

Locations

KR (1)