The Effect of Indocyanine Green Titration on Fluorescent Intensity Degree in Free Flap : A Lookout to Flap Surface Temperature, TCPO2, TCPCO2, HIF-1 Alpha Expression Level, and Histopathology
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- The Effect of Indocyanine Green Fluorescence Intensity to evaluate free flap perfusion
研究概览
简要总结
This study is a randomized clinical trials that aim to determine the effect of Indocyanine Green (ICG) titration dose on the intensity degree of ICG fluorescence imaging results. In addition, this study will also determine the relationship of other indicators such as flap surface temperature, transcutaneous pressure of carbon dioxide (TcPCO2), transcutaneous pressure of oxygen (TcPCO2), HIF - 1 alpha expression, and flap histopathology morphology to the intensity degree of ICG fluorescence imaging results with titrated doses.
详细描述
The ICG contrast solution will be evaluated with Near-Infrared (NIR) camera that being fixated 20 cm above the flap after the injection. The imaging result will be analyzed using ImageJ Application to assess the grey value. The fluorescent intensity of ICG will be compared with other tests.
Drop Out Criteria :
- Patients who are unable to complete the research procedure due to various condition, such as death
- Patients who experience complications or worsening, during and after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The participants didn't know about indocyanine green (ICG) drug groups as well as the concentration that they received. The ICG was added into the syringe by research assistant without any label near the end of operation time. The ICG injection to the patient was performed by anesthesiologist who didn't know about the concentration at all. Outcome assessor didn't know about the given concentration.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Free flap operation that being performed by researchers.
- •Free Flap must have a skin paddle located on the body skin area with intraoperative ischemic time of at least 60 Minutes
- •Free flap should be in a viable/vital condition judged from the clinical examination of the flap, which includes color, temperature, turgor, capillary refill time (CRT), and skin prick test, immediately post surgery
- •Body area that will be a flap-free donor area has no history of trauma or operation
- •Patient with blood albumin value >3 gr / dL
- •The patient/family sign the informed consent sheet stating willingness to become research sample
排除标准
- •Patients have increased sensitivity to iodine or ICG
- •Free Flaps that being transported undergo trauma or damage due to external factors during treatment
- •Patient with high urea and creatinine level
- •Patient with high Alanine transaminase (ALT) and Aspartate transaminase (AST) level
- •Patients who receive injectable heparin treatment containing natrium disulfite preoperatively
- •Patients who regularly take anti-seizure drugs, haloperidol, heroin, meperidine, Metamizole, methadone, morphine, nitrofurantoin, opium, phenobarbital, and phenylbutazone.
研究组 & 干预措施
Group 0,5 mg/mL
This group received 2,5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 0,1 mL ICG is taken using 1 mL syringe using filter that originated from the Aurogreen package. The ICG in the syringe is added with 0,9 mL Dextrose 5%.
干预措施: Indocyanine Green Fluorescence (ICG) (Diagnostic Test)
Group 5 mg/mL
This group received 5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 1 mL ICG using 1 mL syringe using filter that originated from the Aurogreen package.
干预措施: Indocyanine Green Fluorescence (ICG) (Diagnostic Test)
Group 5 mg/mL
This group received 5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 1 mL ICG using 1 mL syringe using filter that originated from the Aurogreen package.
干预措施: Temperature (Diagnostic Test)
Group 5 mg/mL
This group received 5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 1 mL ICG using 1 mL syringe using filter that originated from the Aurogreen package.
干预措施: Transcutaneous oxygen and carbon dioxide pressure (Diagnostic Test)
Group 5 mg/mL
This group received 5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 1 mL ICG using 1 mL syringe using filter that originated from the Aurogreen package.
干预措施: Histopathology (Diagnostic Test)
Group 5 mg/mL
This group received 5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 1 mL ICG using 1 mL syringe using filter that originated from the Aurogreen package.
干预措施: Hypoxia inducible factor-1 (HIF-1) alpha (Diagnostic Test)
Group 2,5 mg/mL
This group received 2,5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 0,5 mL ICG using 1 mL syringe using filter that originated from the Aurogreen package. The ICG in the syringe is added with 0,5 mL Dextrose 5%.
干预措施: Indocyanine Green Fluorescence (ICG) (Diagnostic Test)
Group 2,5 mg/mL
This group received 2,5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 0,5 mL ICG using 1 mL syringe using filter that originated from the Aurogreen package. The ICG in the syringe is added with 0,5 mL Dextrose 5%.
干预措施: Temperature (Diagnostic Test)
Group 2,5 mg/mL
This group received 2,5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 0,5 mL ICG using 1 mL syringe using filter that originated from the Aurogreen package. The ICG in the syringe is added with 0,5 mL Dextrose 5%.
干预措施: Transcutaneous oxygen and carbon dioxide pressure (Diagnostic Test)
Group 2,5 mg/mL
This group received 2,5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 0,5 mL ICG using 1 mL syringe using filter that originated from the Aurogreen package. The ICG in the syringe is added with 0,5 mL Dextrose 5%.
干预措施: Histopathology (Diagnostic Test)
Group 2,5 mg/mL
This group received 2,5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 0,5 mL ICG using 1 mL syringe using filter that originated from the Aurogreen package. The ICG in the syringe is added with 0,5 mL Dextrose 5%.
干预措施: Hypoxia inducible factor-1 (HIF-1) alpha (Diagnostic Test)
Group 0,5 mg/mL
This group received 2,5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 0,1 mL ICG is taken using 1 mL syringe using filter that originated from the Aurogreen package. The ICG in the syringe is added with 0,9 mL Dextrose 5%.
干预措施: Temperature (Diagnostic Test)
Group 0,5 mg/mL
This group received 2,5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 0,1 mL ICG is taken using 1 mL syringe using filter that originated from the Aurogreen package. The ICG in the syringe is added with 0,9 mL Dextrose 5%.
干预措施: Transcutaneous oxygen and carbon dioxide pressure (Diagnostic Test)
Group 0,5 mg/mL
This group received 2,5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 0,1 mL ICG is taken using 1 mL syringe using filter that originated from the Aurogreen package. The ICG in the syringe is added with 0,9 mL Dextrose 5%.
干预措施: Histopathology (Diagnostic Test)
Group 0,5 mg/mL
This group received 2,5 mg/mL concentration of Indocyanine Green (Aurogreen®, Aurolab, Tamil Nadu, India). Indocyanine Green (ICG) is being diluted with 5 mL dextrose 5%. The research assistant take 0,1 mL ICG is taken using 1 mL syringe using filter that originated from the Aurogreen package. The ICG in the syringe is added with 0,9 mL Dextrose 5%.
干预措施: Hypoxia inducible factor-1 (HIF-1) alpha (Diagnostic Test)
结局指标
主要结局
The Effect of Indocyanine Green Fluorescence Intensity to evaluate free flap perfusion
时间窗: Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery
The fluorescence of ICG that being captured with near-infrared (NIR) camera is store in video file to be evaluated. The video duration is 2 minutes long after ICG injection. The fluorescence intensity of the flap in the video is being measured with ImageJ application. The highest level of intensity (numerical data) is considered as the optimal fluorescence intensity that being analyzed later on. The optimal indocyanine green titration will be seen after ImageJ analysis in numerical data called gray values.
次要结局
- Correlation between ICG fluorescence intensity concentration in different titration dose with flap necrosis volume(Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery)
- Correlation between ICG fluorescence intensity in different titration dose with transcutaneous carbon dioxide and oxygen pressure(Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery)
- The ICG fluorescence intensity in different titration dose with flap surface Temperature(Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery)
- Correlation between ICG fluorescence intensity concentration in different titration dose with flap neutrophile count(Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery)
- Correlation between ICG fluorescence intensity concentration in different titration dose with vascular flap proliferation of the tissue(Immediate Postoperative, 24 hours after surgery, 72 hours after surgery, 120 hours after surgery)
- Correlation between ICG fluorescence intensity in different titration dose with HIF-1 Alpha(Intraoperative (before start of anastomosis and before end of anastomosis time), 24 hours after surgery, 72 hours after surgery, 120 hours after surgery)
研究者
Parintosa Atmodiwirjo
Head of Center for Advanced Reconstructive Microsurgery, Principal Investigator
Indonesia University