Considerations for simulation-based evaluation of noninvasive blood pressure monitors

Blood Pressure Monitoring

Volumn 2, Issue 5, 1997, Pages 257-268

  Ng, Kim Gau ^a,b  

^a QUEEN S UNIVERSITY   (Canada)

^b NONE   (Singapore)

Author keywords

Automated sphygmomanometers; Blood pressure monitors; Blood pressure simulation; Device validation; Measurement accuracy; Sample size; Simulation based evaluation

Indexed keywords

BLOOD PRESSURE MONITORING; CLINICAL PROTOCOL; COMPUTER SIMULATION; MONITOR; PRIORITY JOURNAL; REVIEW; SPHYGMOMANOMETER;

EID: 0031464019     PISSN: 13595237     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (58)

1. Standards Australia: Australian Standard AS 3655-1989. Sphygmomanometers. South Melbourne: Standards Australia; 1989.
2. Association for the Advancement of Medical Instrumentation: American National Standard ANSI/AAMI SP10 - 1992. Electronic or Automated Sphygmomanometers. Arlington, VA: Association for the Advancement of Medical Instrumentation; 1993 [a published amendment appeared as ANSI/AAMI SP10A - 1996].
3. O'Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, Altman DG, et al.: The British Hypertension Society protocol for the evaluation of blood pressure measuring devices. J Hypertens 1993, 11 (suppl 2):S43-S62.
4. Deutsches Institut für Normung: DIN 58 130. Nichtinvasive Blutdruckmeßgeräte - Klinische Prüfung. Pforzheim: Deutsches Institut für Normung; 1996.
5. Ng K-G, Small CF: Review of methods & simulators for evaluation of noninvasive blood pressure monitors. J Clin Eng 1992, 17:469-479 [published errata appear in 18:37 (letter) and 19:125-134].
6. Ng K-G, Small CF: Update on methods & simulators for evaluation of noninvasive blood pressure monitors. J Clin Eng 1994, 19:125-134 [published errata appear in 19:348 (letter) and 21:226-244].
7. Amoore JN, Geake WB: An evaluation of three oscillometric non-invasive blood pressure simulators. J Clin Eng 1997, 22:93-100.
8. Mieke S: Substitution of simulators for human subjects. Blood Press Monit 1997, 2:251-256.
9. Amoore JN: Assessment of oscillometric non-invasive blood pressure monitors using the Dynatech Nevada CuffLink analyser. J Med Eng Technol 1993, 17:25-31.
10. Amoore JN, Scott DHT: Noninvasive blood pressure measurements with single and twin-hose systems - do mixtures matter? Anaesthesia 1993, 48:799-802.
11. Mieke S, Groß H, Ulbrich M, Papadopoulos G, Frucht U: Zur Meßsicherheit nichtinvasiver oszillometrischer Blutdruckmeßgeräte. Anaesthesist 1993, 42:38-43.
12. Papadopoulos G, Oldörp B, Mieke S: Die arterielle Blutdruckmessung mit oszillometrischen Geräten bei Neugeborenen und Kleinkindern. Anaesthesist 1994, 43:441-446.
13. Geake WB, Amoore JN, Scott DHT: An automated system for the functional evaluation of oscillometric non-invasive blood pressure monitors. J Med Eng Technol 1995, 19:162-176.
14. Papadopoulos G, Mieke S, Kuhn H-J, Apenburg C: Zur Meßsicherheit der oszillometrischen Blutdruckmeßgeräte Dinamap 1846 und HP M-1008B. Anaesthesist 1996, 45:453-459.
15. Amoore JN: Propaq neonatal monitor used in its own single- or with Critikon twin-hose cuffs: does it matter? Blood Press Monit 1997, 2:41-45.
16. Amoore JN, Geake WB: Evaluation of the Critikon 8100 and SpaceLabs 90207 non-invasive blood pressure monitors using a test simulator. J Hum Hypertens 1997, 11:163-169.
17. Amoore JN, Geake WB, Scott DHT: Oscillometric non-invasive blood pressure measurements: the influence of the make of instrument on readings? Med Biol Eng Comput 1997, 35:131-134.
18. Ng K-G, Small CF: Survey of automated noninvasive blood pressure monitors. J Clin Eng 1994, 19:452-475 [published comments and errata appear in 20:185-186 (letter)].
19. Ng K-G: Automated noninvasive blood pressure measurement Intensive Care World 1995, 12:89-90, 92-102 [published erratum appears in 12:131].
20. Ng K-G: Blood pressure measurement. Med Electron 1997, 28 (1):110-113.
21. American Society of Hypertension: Recommendations for routine blood pressure measurement by indirect cuff sphygmomanometry. Am J Hypertens 1992, 5:207-209.
22. Japanese Standards Association: Japanese Industrial Standard JIS T 1115 - 1987 (Reaffirmed 1992). Noninvasive Electronic Sphygmomanometers. Tokyo: Japanese Standards Association; 1992.
23. Perloff D, Grim C, Flack J, Frohlich ED, Hill M, McDonald M, et al.: Human blood pressure determination by sphygmomanometry. Circulation 1993, 88:2460-2470.
24. World Health Organization/International Society of Hypertension: 1993 Guidelines for the management of mild hypertension: memorandum from a WHO/ISH meeting. Bull WHO 1993, 71:503-517.
25. Association for the Advancement of Medical Instrumentation: American National Standard ANSI/AAMI SP9-1994. Nonautomated Sphygmomanometers. Arlington, VA: Association for the Advancement of Medical Instrumentation; 1994.
26. Campbell NRC, Abbott D, Bass M, Birkett NJ, Chockalingam A, Dagenais GR, et al.: Self-measurement of blood pressure: recommendations of the Canadian Coalition for High Blood Pressure Prevention and Control. Can J Cardiol 1995, 11(suppl H):5H-10H.
27. Comité Européen de Normalisation: European Standard EN 1060-1. Non-Invasive Sphygmomanometers - Part 1: General Requirements. Brussels: Comité Européen de Normalisation; 1995 [available in English, French, and German].
28. Health Canada: Schedule IX. Sphygmomanometers. In Medical Devices Regulations. Scarborough, ON: Health Protection Branch; 1996:42-47 [originally 1978, amended 1996].
29. O'Brien ET, Petrie JC, Littler WA, de Swiet M, Padfield PL, Dillon MJ, et al.: Blood Pressure Measurement. Recommendations of the British Hypertension Society. Third Edition. London: BMJ Publishing Group; 1997.
30. Ng K-G: A basis for use of long cuff bladders in oscillometric blood pressure measurement. J Clin Eng 1996, 21:226-244.
31. Alexander H, Cohen ML, Steinfeld L: Criteria in the choice of an occluding cuff for the indirect measurement of blood pressure. Med Biol Eng Comput 1977, 15:2-10.
32. Stolt M, Sjönell G, Åström H, Hansson L: The reliability of auscultatory measurement of arterial blood pressure. A comparison of the standard and a new methodology. Am J Hypertens 1990, 3:697-703.
33. Verdon F: Mesure de la pression artérielle - quel brassard? Schweiz Med Wochenschr 1992, 122:1491-1496.
34. Geddes LA, Tivey R: The Importance of cuff width in measurement of blood pressure indirectly. Cardiovasc Res Cent Bull 1976, 14:69-79.
35. Geddes LA, Whistler SJ: The error in indirect blood pressure measurement with the incorrect size of cuff. Am Heart J 1978, 96:4-8.
36. van Montfrans GA, van der Hoeven GMA, Karemaker JM, Wieling W, Dunning AJ: Accuracy of auscultatory blood pressure measurement with a long cuff. BMJ 1987, 295:354-355.
37. Arcuri EAM, Santos JLF, Roucha e Silva M: Pulse pressure as a function of cuff width. Braz J Med Biol Res 1988, 21:53-56.
38. Russell AE, Wing LMH, Smith SA, Aylward PE, McRitchie RJ. Hassam RM, et al.: Optimal size of cuff bladder for indirect measurement of arterial pressure in adults. J Hypertens 1989, 7:607-613.
39. Croft PR, Cruickshank JK: Blood pressure measurement in adults: large cuffs for all? J Epidemiol Community Health 1990, 44:170-173.
40. Gómez-Marin O, Prineas RJ, Råstam L: Cuff bladder width and blood pressure measurement in children and adolescents. J Hypertens 1992, 10:1235-1241.
41. Iyriboz Y, Hearon CM, Edwards K: Agreement between large and small cuffs in sphygmomanometry: a quantitative assessment. J Clin Monit 1994, 10:127-133.
42. O'Brien E: Review: a century of confusion; which bladder for accurate blood pressure measurement? J Hum Hypertens 1996, 10:565-572.
43. Ng K-G, Small CF: Changes in oscillometric pulse amplitude envelope with cuff size: implications for blood pressure measurement criteria and cuff size selection. J Biomed Eng 1993, 15:279-282.
44. Iyriboz Y, Hearon CM: A proposal for scientific validation of instruments for indirect blood pressure measurement at rest, during exercise, and in critical care. J Clin Monit 1994, 10:163-177 [published communications appear in 11:149-150].
45. O'Brien E, Atkins N, Mee F, Coyle D, Syed S: A new audiovisual technique for recording blood pressure in research: the Sphygmocorder. J Hypertens 1995, 13:1734-1737.
46. O'Brien E: Towards improving procedures for validating blood pressure measuring devices. Blood Press Monit 1997, 2:247-249.
47. Association for the Advancement of Medical Instrumentation: American National Standard ANSI/AAMI SP10 - 1987. Electronic or Automated Sphygmomanometers. Arlington, VA: Association for the Advancement of Medical Instrumentation; 1987.
48. Comité Européen de Normalisation: European Standard EN 1060-3. Non-Invasive Sphygmomanometers - Part 3: Supplementary Requirements for Electro-Mechanical Blood Pressure Measuring Systems. Brussels: Comité Européen de Normalisation; 1997 [available in English, French, and German].
49. Sloan PJM, Zezulka A, Davies P, Sangal A, Beevers M, Beevers DG: Standardized methods for comparison of sphygmomanometers. J Hypertens 1984, 2:547-551.
50. Atkins N, Mee F, O'Malley K, O'Brien E: The relative accuracy of simultaneous same arm, simultaneous opposite arm and sequential same arm measurements in the validation of automated blood pressure measuring devices. J Hum Hypertens 1990, 4:647-649.
51. Atkins N, O'Brien E, Wesseling KH, Guelen I: Increasing observer objectivity with audio-visual technology: the Sphygmocorder. Blood Press Monit 1997, 2:269-272.
52. O'Brien E, Atkins N: A comparison of the British Hypertension Society and Association for the Advancement of Medical Instrumentation protocols for validating blood pressure measuring devices: can the two be reconciled? J Hypertens 1994, 12:1089-1094.
53. Bland JM, Altman DG: Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986, i:307-310.
54. Bland JM, Altman DG: Comparing methods of measurement: why plotting difference against standard method is misleading. Lancet 1995, 346:1085-1087.
55. International Organization for Standardization: Guide to the Expression of Uncertainty in Measurement. Geneva: International Organization for Standardization; 1993.
56. Snedecor GW, Cochran WG: Statistical Methods. Eighth Edition. Ames, IA: Iowa State University Press; 1989:102-105.
57. Zar JH: Biostatistical Analysis. Third Edition. Upper Saddle River, NJ: Prentice-Hall; 1996:107-110, 133-137, 163-166, 191-197.
58. Gardner MJ, Altman DG: Confidence intervals rather than P values: estimation rather than hypothesis testing. BMJ 1986, 292:746-750.