RIPC During Free Flap With Preoperative Radiotherapy
Primary Purpose
Ischemic Reperfusion Injury, Other Reconstructive Surgery, Radiotherapy
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
remote ischemic preconditioning (RIPC)
Sham-RIPC
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Reperfusion Injury focused on measuring remote ischemic preconditioning, free flap reconstruction, preoperative radiotherapy
Eligibility Criteria
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
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
RIPC
Sham-RIPC
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
tissue oxygen saturation
tissue oxygen saturation of the flap
Secondary Outcome Measures
skin temperature
skin temperature of the flap and the adjacent tissue
myocardial infarct size of the rat Langendorff model
myocardial infarct size of the rat Langendorff model
Full Information
NCT ID
NCT03535623
First Posted
May 14, 2018
Last Updated
April 30, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03535623
Brief Title
RIPC During Free Flap With Preoperative Radiotherapy
Official Title
Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction in Head and Neck Cancer Patients With Preoperative Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 29, 2018 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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, as well as its organ-protective effects using Langendorff isolated heart ischemia-reperfusion model.
Detailed 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.
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 effects of RIPC during free flap reconstructive surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Reperfusion Injury, Other Reconstructive Surgery, Radiotherapy
Keywords
remote ischemic preconditioning, free flap reconstruction, preoperative radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RIPC
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham-RIPC
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
remote ischemic preconditioning (RIPC)
Intervention Description
RIPC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion.
Intervention Type
Other
Intervention Name(s)
Sham-RIPC
Intervention Description
Sham-RIPC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of < 10 mmHg and 5-min reperfusion.
Primary Outcome Measure Information:
Title
tissue oxygen saturation
Description
tissue oxygen saturation of the flap
Time Frame
postoperative day 1
Secondary Outcome Measure Information:
Title
skin temperature
Description
skin temperature of the flap and the adjacent tissue
Time Frame
postoperative day 1
Title
myocardial infarct size of the rat Langendorff model
Description
myocardial infarct size of the rat Langendorff model
Time Frame
24 hr
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Youn Joung Cho, MD
Phone
82-2-2072-2467
Email
mingming7@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youn Joung Cho, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youn Joung Cho, MD
Phone
82-2-2072-3108
Email
mingming7@gmail.com
First Name & Middle Initial & Last Name & Degree
Karam Nam, MD
Phone
82-2-2072-2469
Email
karamnam@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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RIPC During Free Flap With Preoperative Radiotherapy
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