Accuracy of Non Invasive Hemoglobin Measure by SpHb Device in Post Operative Anemia Diagnosis

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06497335

Acronym

SpHb_gyneco

Enrollment

150

Registered

2024-07-11

Start date

2024-06-30

Completion date

2026-01-31

Last updated

2024-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

post operative screening, anemia, iron deficiency, diagnosis

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.

Interventions

DIAGNOSTIC_TESTnon invasive hemoglobin measure

non invasive hemoglobin measure

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
Intra class correlation coefficient	at 2 and 8 months after establishment of PBM protocol	correlation between Laboratory measurement and SpHb measurement
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
Spearman correlation coefficient	at 2 and 8 months after establishment of PBM protocol	correlation between Laboratory Hb and SpHb measure
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
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)

Contacts

Primary ContactSigismond Lasocki

SiLasocki@chu-angers.fr02/41/35/36/37

Backup ContactElise Houssin

DRCI-Promotion-Interne@chu-angers.fr02 41 35 36 37

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026