AnemiaSpHb_gynecoNCT06497335
Accuracy of Non Invasive Hemoglobin Measure by SpHb Device in Post Operative Anemia Diagnosis
An observational study of Anemia, run by University Hospital, Angers.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Anemia
- What is being tested?
- non invasive hemoglobin measure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2024to Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Adult, Older adult
Study population: population of gynecological surgical department
Who may be able to join
- being hospitalized for gynecological procedure: hysterectomy or cancer related annexectomy
- > 18 years
Who cannot join
- non french speaker
- being under a legal individual protection measure
- not being able to consent
- being opposed to data collection
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Anemia
- Being tested
- non invasive hemoglobin measure
- Keywords
- post operative screening, anemia, iron deficiency, diagnosis
- Medical subject headings
- Anemia, Iron Deficiencies, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non invasive hemoglobin measureDiagnostic test
non invasive hemoglobin measure
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 2 and 8 months after establishment of PBM protocol
Secondary outcomes (7)
Spearman correlation coefficient
correlation between Laboratory Hb and SpHb measure
Measured: 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
Measured: at 2 and 8 months after establishment of PBM protocol
Intra class correlation coefficient
correlation between Laboratory measurement and SpHb measurement
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: at 2 and 8 months after establishment of PBM protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start30 Jun 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sigismond Lasocki, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497335
- Sponsor's protocol ID
- 24_0206
- Acronym
- SpHb_gyneco
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06497335
- Acronym / sponsor ID
- SpHb_gyneco / 24_0206
- Conditions
- Anemia
- Keywords
- post operative screening, anemia, iron deficiency, diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- population of gynecological surgical department
Key inclusion criteria (2 listed)
- being hospitalized for gynecological procedure: hysterectomy or cancer related annexectomy
- > 18 years
Key exclusion criteria (4 listed)
- non french speaker
- being under a legal individual protection measure
- not being able to consent
- being opposed to data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non invasive hemoglobin measurenon invasive hemoglobin measure | Diagnostic test | – |
Primary outcome
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
7 secondary outcomes
Spearman correlation coefficient
Time frame: at 2 and 8 months after establishment of PBM protocol
Kappa coefficient
Time frame: at 2 and 8 months after establishment of PBM protocol
Intra class correlation coefficient
Time frame: 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)
Time frame: at 2 and 8 months after establishment of PBM protocol
impact of body temperature on accuracy of SpHb
Time frame: at 2 and 8 months after establishment of PBM protocol
impact of perfusion index on accuracy of SpHb
Time frame: at 2 and 8 months after establishment of PBM protocol
impact of leght between SpHb measurement and laboratory Hb measurement on accuracy
Time frame: at 2 and 8 months after establishment of PBM protocol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sigismond Lasocki principal investigator
University Hospital, Angers
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by University Hospital, Angers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sigismond Lasocki (02/41/35/36/37 ext. +33, SiLasocki@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.