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

NCT06497335 | Not Yet Recruiting

• 1 other identifier: 24_0206
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anemia

Keywords

post operative screening; anemia; iron deficiency; diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• Intra class correlation 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

Interventions

non invasive hemoglobin measure DIAGNOSTIC_TEST

non invasive hemoglobin measure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

population of gynecological surgical department

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Angers: lead

MeSH Terms

Conditions

Anemia; Iron Deficiencies; Disease

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sigismond Lasocki

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sigismond Lasocki

CONTACT

02/41/35/36/37; SiLasocki@chu-angers.fr

Elise Houssin

CONTACT

02 41 35 36 37; DRCI-Promotion-Interne@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 11, 2024
• Study Start: June 30, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share