Accuracy of Non Invasive Hemoglobin Measure by SpHb Device in Post Operative Anemia Diagnosis
- Conditions
- Anemia
- Registration Number
- NCT06497335
- Lead Sponsor
- University Hospital, Angers
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 150
- being hospitalized for gynecological procedure: hysterectomy or cancer related annexectomy
- > 18 years
- non french speaker
- being under a legal individual protection measure
- not being able to consent
- being opposed to data collection
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method accuracy between SpHb measure and Hemoglobin level on the post operative blood sample at 2 and 8 months after establishment of PBM protocol level of immediate post operative SpHb measure compared to blood hemoglobin measure, ROC curve
- Secondary Outcome Measures
Name Time Method Intra class correlation coefficient at 2 and 8 months after establishment of PBM protocol correlation between Laboratory measurement and SpHb measurement
impact of perfusion index on accuracy of SpHb at 2 and 8 months after establishment of PBM protocol comparison of ROC curve areas in subgroups of perfusion index (good or low perfusion index)
impact of leght between SpHb measurement and laboratory Hb measurement on accuracy at 2 and 8 months after establishment of PBM protocol comparison of ROC curve areas in subgroups of lenght in days between SpHb measurement and Laboratory Hb measurement
Spearman correlation coefficient at 2 and 8 months after establishment of PBM protocol correlation between Laboratory Hb and SpHb measure
Kappa coefficient at 2 and 8 months after establishment of PBM protocol correlation between SpHb measure and correct classification of patients anemia vs no anemia
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 comparison of ROC curve areas in subgroups
impact of body temperature on accuracy of SpHb at 2 and 8 months after establishment of PBM protocol comparison of ROC curve areas in subgroups of temperature (classes of temperature : \<35; 35-36; \>36)