Pronto-7: Accuracy of Non-invasive Hemoglobin Measurement in Parturients
NCT ID: NCT01893645
Last Updated: 2014-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
71 participants
OBSERVATIONAL
2013-06-30
2014-04-30
Brief Summary
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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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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Pregnant women
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.
Pronto-7
A new point-of-care pulse co-oximeter that offers a non-invasive and quick spot-checking of Hb (SpHb).
Interventions
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Pronto-7
A new point-of-care pulse co-oximeter that offers a non-invasive and quick spot-checking of Hb (SpHb).
Eligibility Criteria
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Inclusion Criteria
* Understand written and oral English
* Are greater than 37 weeks gestational age
* Have a singleton pregnancy
Exclusion Criteria
* Have abnormal Hb disorders
* Have hyperbilirubinemia
* Have a peripheral vascular disease (e.g. Reynaud's syndrome)
* Have long or acrylic nails
19 Years
40 Years
FEMALE
Yes
Sponsors
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Masimo Corporation
INDUSTRY
University of British Columbia
OTHER
Responsible Party
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Principal Investigators
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Vit Gunka, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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BC Women's Hospital
Vancouver, British Columbia, Canada
Countries
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References
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Macknet MR, Allard M, Applegate RL 2nd, Rook J. The accuracy of noninvasive and continuous total hemoglobin measurement by pulse CO-Oximetry in human subjects undergoing hemodilution. Anesth Analg. 2010 Dec;111(6):1424-6. doi: 10.1213/ANE.0b013e3181fc74b9. Epub 2010 Nov 3.
Miller RD, Ward TA, Shiboski SC, Cohen NH. A comparison of three methods of hemoglobin monitoring in patients undergoing spine surgery. Anesth Analg. 2011 Apr;112(4):858-63. doi: 10.1213/ANE.0b013e31820eecd1. Epub 2011 Mar 8.
Berkow L, Rotolo S, Mirski E. Continuous noninvasive hemoglobin monitoring during complex spine surgery. Anesth Analg. 2011 Dec;113(6):1396-402. doi: 10.1213/ANE.0b013e318230b425. Epub 2011 Sep 29.
Lamhaut L, Apriotesei R, Combes X, Lejay M, Carli P, Vivien B. Comparison of the accuracy of noninvasive hemoglobin monitoring by spectrophotometry (SpHb) and HemoCue(R) with automated laboratory hemoglobin measurement. Anesthesiology. 2011 Sep;115(3):548-54. doi: 10.1097/ALN.0b013e3182270c22.
Causey MW, Miller S, Foster A, Beekley A, Zenger D, Martin M. Validation of noninvasive hemoglobin measurements using the Masimo Radical-7 SpHb Station. Am J Surg. 2011 May;201(5):592-8. doi: 10.1016/j.amjsurg.2011.01.020.
Butwick A, Hilton G, Carvalho B. Non-invasive haemoglobin measurement in patients undergoing elective Caesarean section. Br J Anaesth. 2012 Feb;108(2):271-7. doi: 10.1093/bja/aer373. Epub 2011 Nov 23.
Gayat E, Aulagnier J, Matthieu E, Boisson M, Fischler M. Non-invasive measurement of hemoglobin: assessment of two different point-of-care technologies. PLoS One. 2012;7(1):e30065. doi: 10.1371/journal.pone.0030065. Epub 2012 Jan 6.
Sun J, Chernick MR, LaBudde RA. A bootstrap test for comparing two variances: simulation of size and power in small samples. J Biopharm Stat. 2011 Nov;21(6):1079-93. doi: 10.1080/10543406.2011.611082.
Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
Related Links
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Related Info about the Pronto-7 Device
Other Identifiers
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H12-00755
Identifier Type: -
Identifier Source: org_study_id