NCT06497335尚未招募不适用
Accuracy of Non Invasive Hemoglobin Measure by SpHb Device in Post Operative Anemia Diagnosis: a Validation Study in Gynecological Surgery Department of Angers 's University Hospital
University Hospital, Angers0 个研究点目标入组 150 人开始时间: 2024年6月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- accuracy between SpHb measure and Hemoglobin level on the post operative blood sample
研究概览
简要总结
Non invasive Hemoglobin monitoring by SpHb device had been developed to assess Hemoglobin level during hemorrhagic surgery. It's accuracy to detect post operative anemia on a single post operative measure has been recently demonstrated on a cohort of post operative orthopedic patient and it's routine use has been generalized to other surgical department. This study aims to valid these finding on a cohort of post operative patients from gynaecological department.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •being hospitalized for gynecological procedure: hysterectomy or cancer related annexectomy
- •> 18 years
排除标准
- •non french speaker
- •being under a legal individual protection measure
- •not being able to consent
- •being opposed to data collection
结局指标
主要结局
accuracy between SpHb measure and Hemoglobin level on the post operative blood sample
时间窗: at 2 and 8 months after establishment of PBM protocol
level of immediate post operative SpHb measure compared to blood hemoglobin measure, ROC curve
次要结局
- Intra class correlation coefficient(at 2 and 8 months after establishment of PBM protocol)
- impact of perfusion index on accuracy of SpHb(at 2 and 8 months after establishment of PBM protocol)
- impact of leght between SpHb measurement and laboratory Hb measurement on accuracy(at 2 and 8 months after establishment of PBM protocol)
- Spearman correlation coefficient(at 2 and 8 months after establishment of PBM protocol)
- Kappa coefficient(at 2 and 8 months after establishment of PBM protocol)
- Subgroup analysis of ROC curve (classes of age 18-30; 30-40; 40-50; >50)(at 2 and 8 months after establishment of PBM protocol)
- impact of body temperature on accuracy of SpHb(at 2 and 8 months after establishment of PBM protocol)
研究者
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