Clinical trial NCT03474952: Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction
Official title: Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction in Head and Neck Cancer Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Remote Ischemic Preconditioning
Keywords: remote ischemic preconditioning
free flap reconstruction
tissue oxygen saturation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RIPC group and control (sham-RIPC) group
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: tissue oxygen saturation
timeFrame: postoperative day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Youn Joung Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Min SH, Choe SH, Kim WS, Ahn SH, Cho YJ. Effects of ischemic conditioning on head and neck free flap oxygenation: a randomized controlled trial. Sci Rep. 2022 May 17;12(1):8130. doi: 10.1038/s41598-022-12374-3.