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

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Pregnant women	Pronto-7	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Comparisons of SpHb values	15-20 minutes before venipuncture and 15-20 minutes after venipuncture	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.

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