Pronto-7: Accuracy of Non-invasive Hemoglobin Measurement in Parturients

Study Overview
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Brief Summary
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The measurement of blood hemoglobin (Hb) concentration is a routine procedure in pregnant women. The assessment of Hb involves several steps, including a needle stick, blood collection, blood sample analysis in the laboratory, and waiting for the results. Pronto-7 (manufactured by Masimo, CA, USA) is a new portable device that allows a quick bedside Hb spot check. A finger clip probe, similar to the standard oxygen finger clip probe, provides hemoglobin values in less than 60 seconds. In this prospective observational study the investigators will assess the clinical accuracy of Pronto-7 derived Hb values compared to the gold standard laboratory Hb values in obstetric patients. We will be calculating the mean difference between Pronto-7 and laboratory Hb values. We plan to recruit 55 pregnant women admitted for vaginal or cesarean delivery at BC Women's Hospital.

Detailed Description
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Serum hemoglobin (Hb) concentration is one of the most common laboratory tests measured when a pregnant woman (parturient) is admitted for a vaginal or cesarean delivery. The Hb concentration is normally measured from a venous blood sample in clinical laboratories using co-oximetry. A new point-of-care pulse co-oximeter, the Pronto-7 (Masimo Corporation, Irvine, CA, USA), is a portable device that offers a non-invasive and quick spot-checking of Hb (SpHb). Measurement with the Pronto-7 takes about 60 seconds and does not require the transfer of blood samples to a laboratory. In addition to SpHb, the device provides a perfusion index (PI) value (a numeric estimation of the pulse strength at the measurement site), heart rate, oxygen saturation, and finger temperature. Potential advantages of the Pronto-7 include reduced staff work, decreased exposure to potential biohazards, and reduced pain and discomfort to the patient. A similar technology is used in Radical-7 pulse co-oximeter (Masimo Corporation, Irvine, CA, USA) for non-invasive Hb measurement. Radical-7 has been evaluated in human volunteers undergoing hemodilution, in patients undergoing spine surgeries, major urological procedures, and in critically ill patients. However, the results regarding the accuracy of this technology are conflicting.

Official Title
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Pronto-7: Accuracy of Non-invasive Hemoglobin Measurement in Parturients

Conditions
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Hemoglobin Levels in Blood

Intervention / Treatment
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* Device: Pronto-7


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are 19 - 40 years old Understand written and oral English Are greater than 37 weeks gestational age Have a singleton pregnancy Exclusion Criteria: Have a laboratory Hb less than 100 g/L Have abnormal Hb disorders Have hyperbilirubinemia Have a peripheral vascular disease (e.g. Reynaud's syndrome) Have long or acrylic nails

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women<br>Pregnant women admitted to the British Columbia Women's Hospital for vaginal or cesarean delivery will get their Hb values spot-checked using the Pronto-7 device. | Device: Pronto-7<br>* A new point-of-care pulse co-oximeter that offers a non-invasive and quick spot-checking of Hb (SpHb).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin (Hb) value | Difference between the pre-venipuncture SpHb values and the laboratory Hb values (SpHb-Lab Hb difference) measured from the same extremity of each subject | 15-20 minutes before venipuncture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparisons of SpHb values | Comparison between right and left hand SpHb values measured immediately before venipuncture. Comparison between right and left hand SpHb values measured immediately after venipuncture. Comparison of SpHb values measured from the same extremity immediately before and after venipuncture. Comparison of the SpHb-lab Hb differences between subjects in labour for vaginal delivery and subjects undergoing elective cesarean delivery. | 15-20 minutes before venipuncture and 15-20 minutes after venipuncture | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pronto-7, SpHb, Obstetric patients