Diego Lozano, MD., Andrea Stebor, RN, Ph.D., Rana F. Mikhail, Ph.D
The purpose of this clinical study was to determine the accuracy of the DINAMAP™ SuperSTAT blood pressure technology in neonatal/infant subjects according to the ANSI/AAMI SP-10:2002 Standard. Systolic, diastolic, mean arterial pressure (MAP), and pulse rate (PR) were compared to intra-arterial blood pressure (IBP). The study took place in neonatal intensive care units and cardiac catheterization laboratories. Institutional Review Board (IRB) approvals were granted and informed consent was obtained.
Data were collected according to the ANSI/AAMI SP-10:2002 Standard specifications, utilizing static and dynamic calibration procedures to ensure the accuracy of the IBP. A computer program recorded the SuperSTAT NIBP simultaneously with the IBP. A sample of 15 neonatal and 6 infant subjects was in the data analysis. NIBP determinations were taken using a blood pressure cuff on the neonate’s calf or infant’s upper arm. Six sizes of blood pressure cuffs were used; neonatal CRITIKON™ SOFT-CUF™ cuff sizes 2, 3, 4, and 5, as well as CRITIKON DURA-CUF™ infant and child size cuffs.
The differences between the SuperSTAT algorithm and the IBP reference were analyzed according to the ANSI/ AAMI SP-10:2002 Standard. see Table 1.
The SuperSTAT NIBP algorithm met the ANSI/AAMI SP-10:2002 Standard accuracy specifications of ± 5 mmHg for mean difference and ≤ 8 mmHg standard deviation for the neonatal/infant population.