Comparison of a radial artery compression device with invasive radial artery blood pressure monitoring.

OBJECTIVE: The goal of this study was to validate the accuracy of the Primo radial artery compression device (RACD) according to the guidelines recommended by the American National Standards Institute/Association for the Advancement of Medical Instrumentation (AAMI) SP10-2002 Standards for Electronic or Automated Sphygmomanometers. METHODS: A prospective, nonblind, convenience sample trial at a level 1 trauma center (annual emergency department census 70,000) enrolled 17 adult patients with preexisting radial artery line catheters (RAL). Each patient had 10 blood pressure measurements giving an n=170. This number is consistent with calculations on the basis of the American National Standards Institute/AAMI guidelines. RESULTS: The mean arterial pressures (MAPs), systolic blood pressures (SBPs), and diastolic blood pressures (DBPs) measured by both the RACD and the RAL were compared. The R for the RAL/RACD were 0.94, 0.96, and 0.85 for MAP, SBP, and DBP, respectively (P<0.05). The mean difference between the RAL MAP and the RACD MAP was +1.0 mmHg (95% confidence interval, -1.69 to -0.33). The mean SBP difference was -2.8 mmHg (SD 6.4 mmHg) and the mean DBP difference was +2.6 mmHg (SD 5.7 mmHg). CONCLUSION: The RACD meets the guidelines for automated blood pressure monitors set by the AAMI SP10-2002 Standards for Electronic or Automated Sphygmomanometers with an accuracy of +/- 5 mmHg and SD of 8 mmHg or less for both SBP and DBP measurements.