The technology used in the BMEYE Nexfin, to measure blood pressure, has failed in clinical validation studies, in general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications. It has also been assessed, in general and specific populations, according to non-standard protocols.
|Medaval||None||When an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.|
Akkermans J, Diepeveen M, Ganzevoort W, van Montfrans GA, Westerhof BE, Wolf H. Continuous non-invasive blood pressure monitoring, a validation study of Nexfin in a pregnant population. Hypertens Pregnancy. 2009 May;28(2):230-42. doi: 10.1080/10641950802601260. PMID: 19437233.
ESH-IP:2002 - Fail General population (Note: Failed Phase 2.2)
Eeftinck Schattenkerk DW, van Lieshout JJ, van den Meiracker AH, Wesseling KR, Blanc S, Wieling W, van Montfrans GA, Settels JJ, Wesseling KH, Westerhof BE. Nexfin noninvasive continuous blood pressure validated against Riva-Rocci/Korotkoff. Am J Hypertens. 2009 Apr;22(4):378-83. Epub: 2009 Jan 29. doi: 10.1038/ajh.2008.368. PMID: 19180062. Available from: academic.oup.com.
Ad Hoc protocol AdHoc validation against the Finometer. Study not independent of BMEYE.
Ameloot K, Van De Vijver K, Van Regenmortel N, De Laet I, Schoonheydt K, Dits H, Broch O, Bein B, Malbrain ML. Validation study of Nexfin® continuous non-invasive blood pressure monitoring in critically ill adult patients. Minerva Anestesiol. 2014 Dec;80(12):1294-301. Epub: 2014 Apr 4. doi: doi: 10.1097/MBP.0000000000000063. PMID: 24705004.
IA protocol Critically ill patients (Note: IA validation (n=225/45))
Pouwels S, Lascaris B, Nienhuijs SW, Arthur Bouwman R, Buise MP. Validation of the Nexfin® non-invasive continuous blood pressure monitoring validated against Riva-Rocci/Korotkoff in a bariatric patient population. J Clin Anesth. 2017 Jun;39:89-95. Epub: 2017 May 31. doi: 10.1016/j.jclinane.2017.03.029. PMID: 28494917.
ESH-IP:2010 - Fail Obese patients scheduled for bariatric surgery (n=33)
Monnet X, Picard F, Lidzborski E, Mesnil M, Duranteau J, Richard C, Teboul JL. The estimation of cardiac output by the Nexfin device is of poor reliability for tracking the effects of a fluid challenge. Crit Care. 2012 Oct 29;16(5):R212. doi: 10.1186/cc11846. PMID: 23107227. Available from: ccforum.biomedcentral.com.
Validation of Cardiac Output feature: "The estimation of cardiac output by the Nexfin device in critically ill patients is not reliable, neither for estimating absolute values of cardiac output nor for tracking its changes during volume expansion."
Ameloot K, Van De Vijver K, Broch O, Van Regenmortel N, De Laet I, Schoonheydt K, Dits H, Bein B, Malbrain ML. Nexfin noninvasive continuous hemodynamic monitoring: validation against continuous pulse contour and intermittent transpulmonary thermodilution derived cardiac output in critically ill patients. ScientificWorldJournal. 2013 Nov 11;2013(519080):11 p. doi: 10.1155/2013/519080. PMID: 24319373. Available from: www.hindawi.com. eCollection 2013.
Validation of Cardiac Output feature: "Nexfin obtained CO showed a moderate to good correlation with CO measured by PiCCO although the PE was too high."
Feenstra RK, Allaart CP, Berkelmans GFN, Westerhof BE, Smulders YM. Accuracy of oscillometric blood pressure measurement in atrial fibrillation. Blood Press Monit. 2018 Apr;23(2):59-63. Epub: 2017 Dec 17. doi: 10.1097/MBP.0000000000000305. PMID: 29256921.
The publication describes the BMEYE Nexfin being used as a validation control device.