Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction

Remote Ischemic Preconditioning Clinical Trial

Official title:

Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction in Head and Neck Cancer Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474952
• Other study ID #: RIPC during free flap
• Status: Completed
• Phase: N/A
• Start date: April 13, 2018
• Est. completion date: December 9, 2019

Study information

• Verified date: March 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 9, 2019
• Est. primary completion date: December 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Remote Ischemic Preconditioning

Intervention

Procedure:
• remote ischemic preconditioning (RIPC)
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
ischemia pressure less than 10 mmHg (sham-RIPC)

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 free flap	postoperative day 1