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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anemia
• Intervention / Treatment: Diagnostic test: non invasive hemoglobin measure

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Elise Houssin; Phone Number: +33 02 41 35 36 37; Email: DRCI-Promotion-Interne@chu-angers.fr
• Study Contact Backup: Name: Sigismond Lasocki; Phone Number: +33 02/41/35/36/37; Email: SiLasocki@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

population of gynecological surgical department

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
accuracy between SpHb measure and Hemoglobin level on the post operative blood sample	level of immediate post operative SpHb measure compared to blood hemoglobin measure, ROC curve	at 2 and 8 months after establishment of PBM protocol

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spearman correlation coefficient	correlation between Laboratory Hb and SpHb measure	at 2 and 8 months after establishment of PBM protocol
Kappa coefficient	correlation between SpHb measure and correct classification of patients anemia vs no anemia	at 2 and 8 months after establishment of PBM protocol
Intra class correlation coefficient	correlation between Laboratory measurement and SpHb measurement	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)	comparison of ROC curve areas in subgroups	at 2 and 8 months after establishment of PBM protocol
impact of body temperature on accuracy of SpHb	comparison of ROC curve areas in subgroups of temperature (classes of temperature : <35; 35-36; >36)	at 2 and 8 months after establishment of PBM protocol
impact of perfusion index on accuracy of SpHb	comparison of ROC curve areas in subgroups of perfusion index (good or low perfusion index)	at 2 and 8 months after establishment of PBM protocol
impact of leght between SpHb measurement and laboratory Hb measurement on accuracy	comparison of ROC curve areas in subgroups of lenght in days between SpHb measurement and Laboratory Hb measurement	at 2 and 8 months after establishment of PBM protocol

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Sigismond Lasocki, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: anemia; diagnosis; iron deficiency; post operative screening
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Chrysarobin
• Other Study ID Numbers: 24_0206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No