Validation of the Saadat NIBP module according to the ANSI/AAMI-SP10 protocol

Abstract

This study is conducted with the aim of validating the Saadat non-invasive blood pressure (NIBP) module accuracy and reliability against direct intra arterial pressure measurement (IBP) according to the ANSI/AAMI SP10-2002 guidelines. Measurement and comparison procedure were done in a static population of 19 adult patients with brachial catheterized arterial line with total measurements of 195 under supervision of a highly experienced cardiovascular anesthesiologist in accordance with the ANSI/AAMI SP10-2002 regulation. Data analysis was performed based on the protocol criteria. In order to represent relationships between the test device and the reference method, Bland-Altman graphical plotting method was used. The mean ± SD differences between the readings of Saadat NIBP device and IBP as the reference method for systolic, diastolic and map pressures were: -0.9 ± 6.95 mmHg for systolic, 2.57 ± 7.79 mmHg for Diastolic, and 3.89 ± 7.06 mmHg for Map. The Saadat NIBP module fulfilled the ANSI/AAMI SP10-2002 requirement that is the mean ± SD of lower than 5 ± 8 mmHg.

Usefulness of a radial applanation tonometry device in blood pressure related clinical decision making by anesthesiologists

“…NIBP is considered a standard method in today's operating rooms regarding its quick and easy employment and appropriateness for the needs of a majority of physicians and patients not requiring blood gas analyses. Most anesthetists believe to be able to cope with the drawbacks of NIBP like wrong cuff size and the ABP blind window of 5 min or longer, although there exists evidence that both can have a negative impact on accuracy or outcome [17][18][19][20]. The third method, radial applanation tonometry using AT, is an alternative that combines the best of both worlds, being continuous yet non-invasive.…”

“…As such, for the first time we could show that IBP and AT are clinically equivalent for decision making but not IBP and NIBP are not, the latter having missed several moments of hypotension or hypertension (1, IQR 0-2). Given also the inherent risks on patient outcome associated with blind moments of the NIBP technology [17,19,20] AT is clearly superior to NIBP.…”

Usefulness of a radial applanation tonometry device in blood pressure related clinical decision making by anesthesiologists

“…NIBP may be considered as a standard method in today's operating rooms regarding practicability, quick and easy employment and appropriateness for the needs of a majority of physicians and patients not requiring blood gas analyses. Most anesthetists believe to be able to cope with the drawbacks of NIBP like wrong cuff size and the ABP blind window of 5min or longer, although there exists evidence that both can have a negative impact on accuracy or outcome [17][18][19][20].The third method, radial applanation tonometry using AT, is an alternative that combines the best of both worlds, being continuous but being still non-invasive. Nevertheless, this offer needs to be validated before it either can be a replacement of the other two methods or can be filling the gap in between.…”

“…As such, for the first time we could show that IBP and AT are clinically equivalent for decision making but not IBP and NIBP, the latter missing several moments of hypotension or hypertension (1, IQR 0-2). Given also the inherent risks on patient outcome associated with blind moments of the NIBP technology 17,19,20] AT is clearly superior to NIBP.…”