Sjaak Pouwels1, Bianca Lascaris2, Simon W Nienhuijs3, R Arthur Bouwman2, Marc P Buise2. 1. Department of Surgery, St Franciscus & Vlietland, Schiedam, The Netherlands; Department of Epidemiology, CAPHRI Research School, Maastricht University, The Netherlands. Electronic address: Sjaakpwls@gmail.com. 2. Department of Anaesthesiology, Intensive Care and Pain Medicine, Catharina Hospital, Eindhoven, The Netherlands. 3. Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands.
Abstract
STUDY OBJECTIVE: The present study aimed to validate the Nexfin® monitor and to assess the accuracy compared to classical sphygmomanometry (Riva-Rocci/Korotkoff (RRK)) blood pressure (BP) measurements in patients with obesity scheduled for bariatric surgery. DESIGN: Validation study. SETTING: Outpatient clinic for bariatric surgery. PATIENTS: 33 patients scheduled for bariatric surgery. MEASUREMENTS: The validation process was done according to the protocols developed by the European Society of Hypertension from 2010. The Nexfin® monitor (Edwards Lifesciences/BMEYE B.V., Amsterdam, The Netherlands) calculates beat-to-beat blood pressure from finger pulse wave analysis. Measurements of systolic and diastolic BP were obtained using classical sphygmomanometry and the Nexfin® alternatingly. MAIN RESULTS: In total 99 pairs of BP measurements were used. The device failed pass phase 1 as 65 systolic readings fell within 5mmHg (73 required). And 61, 76 and 90 diastolic readings fell within 5, 10 and 15mmHg respectively. Finally, it failed to pass phase 2 as 23 patients for systolic and 25 for diastolic had at least 2/3 of their comparisons falling within 5mmHg (24 required) but 10 subjects for systolic and 8 for diastolic had all three comparisons more than 5mmHg different from the RRK readings (zero allowed). Mean differences were 7.8±6.9mmHg for SBP and 8.0±7.2mmHg for DBP. CONCLUSION: Using the revised protocol, the Nexfin® device was not able to pass validation. However using the original protocol, the Nexfin® device passed phase 1 and 2.1 of the validation process and failed to pass phase 2.2.
STUDY OBJECTIVE: The present study aimed to validate the Nexfin® monitor and to assess the accuracy compared to classical sphygmomanometry (Riva-Rocci/Korotkoff (RRK)) blood pressure (BP) measurements in patients with obesity scheduled for bariatric surgery. DESIGN: Validation study. SETTING:Outpatient clinic for bariatric surgery. PATIENTS: 33 patients scheduled for bariatric surgery. MEASUREMENTS: The validation process was done according to the protocols developed by the European Society of Hypertension from 2010. The Nexfin® monitor (Edwards Lifesciences/BMEYE B.V., Amsterdam, The Netherlands) calculates beat-to-beat blood pressure from finger pulse wave analysis. Measurements of systolic and diastolic BP were obtained using classical sphygmomanometry and the Nexfin® alternatingly. MAIN RESULTS: In total 99 pairs of BP measurements were used. The device failed pass phase 1 as 65 systolic readings fell within 5mmHg (73 required). And 61, 76 and 90 diastolic readings fell within 5, 10 and 15mmHg respectively. Finally, it failed to pass phase 2 as 23 patients for systolic and 25 for diastolic had at least 2/3 of their comparisons falling within 5mmHg (24 required) but 10 subjects for systolic and 8 for diastolic had all three comparisons more than 5mmHg different from the RRK readings (zero allowed). Mean differences were 7.8±6.9mmHg for SBP and 8.0±7.2mmHg for DBP. CONCLUSION: Using the revised protocol, the Nexfin® device was not able to pass validation. However using the original protocol, the Nexfin® device passed phase 1 and 2.1 of the validation process and failed to pass phase 2.2.
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