Pronto-7: Accuracy of Non-invasive Hemoglobin Measurement in Parturients (Pronto-7)
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|ClinicalTrials.gov Identifier: NCT01893645|
Recruitment Status : Completed
First Posted : July 9, 2013
Last Update Posted : September 30, 2014
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.
|Condition or disease||Intervention/treatment|
|Hemoglobin Levels in Blood||Device: Pronto-7|
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.
|Study Type :||Observational|
|Actual Enrollment :||71 participants|
|Official Title:||Pronto-7: Accuracy of Non-invasive Hemoglobin Measurement in Parturients|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
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.
A new point-of-care pulse co-oximeter that offers a non-invasive and quick spot-checking of Hb (SpHb).
- Hemoglobin (Hb) value [ Time Frame: 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
- Comparisons of SpHb values [ Time Frame: 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.
- Consistency of lab Hb results [ Time Frame: 4 hours after venipuncture ]Comparison between the first and second reading on the laboratory Cooximeter.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893645
|Canada, British Columbia|
|BC Women's Hospital|
|Vancouver, British Columbia, Canada, V6H 3N1|
|Principal Investigator:||Vit Gunka, MD||University of British Columbia|