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 R2 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.
