NCT01893645|Completed
Pronto-7: Accuracy of Non-invasive Hemoglobin Measurement in Parturients
Pronto-7
Loading search results
Pronto-7
Sponsor study identifier
observational
71
1 country
1
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2014
Actual (reported)Study Completion
April 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 3, 2012
Actual (reported)June 2013
Date type not reportedThis date has not been verified as actual or estimated.
July 9, 2013
Actual (reported)April 2014
Actual (reported)April 2014
Actual (reported)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
Comparisons of SpHb values
15-20 minutes before venipuncture and 15-20 minutes after venipuncture
Consistency of lab Hb results
4 hours after venipuncture
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Pregnant women admitted to the British Columbia Women's Hospital for vaginal or cesarean delivery (either elective or emergency).
BC Women's Hospital
Vancouver, British Columbia, V6H 3N1, Canada
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.
Vit Gunka, MD
University of British Columbia
71 participants (actual enrollment reported by the registry).
First Submitted
October 3, 2012
First Posted
July 9, 2013
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
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.
Primary Completion
April 2014
Actual (reported)Study Completion
April 2014
Actual (reported)Last Updated
September 30, 2014
Record last verified: 2014-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: