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NCT03535623 Clinical Trial

RIPC During Free Flap With Preoperative Radiotherapy

Radiotherapy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03535623
Other study ID # RIPC during FF with RT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 29, 2018
Est. completion date April 18, 2024

Study information
Verified date May 2024
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date April 18, 2024
Est. primary completion date March 20, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• remote ischemic preconditioning (RIPC)
RIPC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion.
• Sham-RIPC
Sham-RIPC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of < 10 mmHg and 5-min reperfusion.

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary tissue oxygen saturation tissue oxygen saturation of the flap postoperative day 1
Secondary skin temperature skin temperature of the flap and the adjacent tissue postoperative day 1
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