The Effects of Caffeine on DIEP Flap Perfusion: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Absolute value of tissue oxygenation saturation (StO2) amount of change
研究概览
简要总结
Women that require breast reconstruction and meet eligibility will be enrolled in this study. The study is being completed to determine the effect of caffeine in deep inferior epigastric perforator (DIEP) flap perfusion using the Vioptix tissue oximeter monitor and to determine if caffeine in the acute postoperative period affects overall flap complication or loss (complete loss from anastomotic issue).
The researchers hypothesize that a single 8 ounce cup of regular coffee will not affect free flap perfusion as indicated by the Vioptix, and that it will not affect overall free flap survival at thirty days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Patient and observer will be blinded to which group they were assigned.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •regular caffeine consumers undergoing unilateral or bilateral microsurgical breast reconstruction with DIEP flap(s) at the University of Michigan Health System
排除标准
- •hepatic or renal disease (comorbidities that affect caffeine metabolism)
研究组 & 干预措施
Caffeinated Coffee
干预措施: Caffeinated Coffee (Dietary Supplement)
Decaffeinated Coffee
干预措施: DecaffeinatedCoffee (Dietary Supplement)
结局指标
主要结局
Absolute value of tissue oxygenation saturation (StO2) amount of change
时间窗: up to 165 minutes (30 minutes prior to coffee consumption, 15 minutes for coffee consumption, 120 more minutes after consumption)
St02 will be measured using the Vioptix tissue oximeter monitor. These will be summarized using means and standard deviations.
Analysis of feasibility
时间窗: approximately 6 months after recruitment starts
The total number of patients recruited per month, the rate of successful enrollment, and the rate of successful study completion will be evaluated.
Absolute value of tissue oxygenation saturation (StO2) rate of change
时间窗: up to 165 minutes (30 minutes prior to coffee consumption, 15 minutes for coffee consumption, 120 more minutes after consumption)
St02 will be measured using the Vioptix tissue oximeter monitor. These will be summarized using means and standard deviations.
Absolute value of tissue oxygenation saturation (StO2)
时间窗: up to 165 minutes (30 minutes prior to coffee consumption, 15 minutes for coffee consumption, 120 more minutes after consumption)
St02 will be measured using the Vioptix tissue oximeter monitor. These will be summarized using means and standard deviations.
次要结局
- Incidence of major flap complications in the caffeine and non-caffeine groups(up to 30 days post-operatively)
- Incidence of minor flap complications in the caffeine and non-caffeine groups(up to 30 days post-operatively)
研究者
Adeyiza Momoh
Associate Professor of Surgery
University of Michigan