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临床试验/NCT05769244
NCT05769244已完成不适用

Near Infrared Spectroscopy and Testicular Torsion in Children

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2020年6月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
2
主要终点
mean tissue oxygenation percentage (NIRS measurements) of the both testicles for boys with scrotal pain

研究概览

简要总结

NIRS estimates tissue saturation of oxygenation in tissue beds. Animals studies suggested that transscrotal NIRS measurements can quantify testicular hypoxia and differentiate between torsed and non torsed testicles. The results of human studies are not conclusive. The hypothesis is that the difference in NIRS values between torsed and healthy testicles would not be zero and that this difference would be zero in control group and that NIRS could help to detect rapidly a TT Testicular torsion (TT) is a functional emergency. The diagnosis is sometimes difficult to make. No paraclinical examination can eliminate it with certainty. The investigators aimed to evaluate the interest of transscrotal near-infrared spectroscopy (NIRS) for the diagnosis of TT of child

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • Step 1: healthy boys between 0 and 16 years old
  • Step 2Testicular pain group (Group 1 and 2): boy under 18 years, testicular pain

排除标准

  • cutaneous scrotal lesion,
  • fever (for the control group),
  • hypertension

结局指标

主要结局

mean tissue oxygenation percentage (NIRS measurements) of the both testicles for boys with scrotal pain

时间窗: one day

Near-infrared spectroscopy (NIRS) is a noninvasive technology that continuously monitors regional tissue oxygenation. Originally used for assessment of oxygen saturation of the brain, its use has now been expanded to evaluation of oxygenation of tissues other than the brain. Normal values for NIRS values are between 60-75% but physiological values of 55-60% have been reported in some cardiac patients

mean tissue oxygenation percentage (NIRS measurements) between both testicles for boys with scrotal pain

时间窗: one day

Near-infrared spectroscopy (NIRS) is a noninvasive technology that continuously monitors regional tissue oxygenation. Originally used for assessment of oxygen saturation of the brain, its use has now been expanded to evaluation of oxygenation of tissues other than the brain. Normal values for NIRS values are between 60-75% but physiological values of 55-60% have been reported in some cardiac patients

mean tissue oxygenation percentage (NIRS measurements) of the testicles for healthy boys

时间窗: one day

Near-infrared spectroscopy (NIRS) is a noninvasive technology that continuously monitors regional tissue oxygenation. Originally used for assessment of oxygen saturation of the brain, its use has now been expanded to evaluation of oxygenation of tissues other than the brain. Normal values for NIRS values are between 60-75% but physiological values of 55-60% have been reported in some cardiac patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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