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 sites150 target enrollmentJune 30, 2024

ConditionsAnemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anemia
Sponsor: University Hospital, Angers
Enrollment: 150
Primary Endpoint: accuracy between SpHb measure and Hemoglobin level on the post operative blood sample
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 30, 2024

End Date

January 2026

Last Updated

last year

Study Type

Observational

Sex

Female

Investigators

Sponsor

University Hospital, Angers

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•being hospitalized for gynecological procedure: hysterectomy or cancer related annexectomy
•\> 18 years

Exclusion Criteria

•non french speaker
•being under a legal individual protection measure
•not being able to consent
•being opposed to data collection

Outcomes

Primary Outcomes

accuracy between SpHb measure and Hemoglobin level on the post operative blood sample

Time Frame: 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 Outcomes

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)