Masimo’s rainbow® Acoustic Monitoring (RAM™) was Associated with Fewer Alarm Events During Planned Moderate Sedation in New Clinical Study
For Breath Rates Less Than or Equal to 4 Breaths Per Minute, RAM Showed 78% True Positives and 22% False Positives, While Capnography Showed 30% True Positives and 70% False Positives
This two-part pilot study used RAM and SedLine® brain function monitoring as the additional monitoring parameters during planned moderate sedation to (1) determine the incidences of alarm events (desaturation, respiratory depression and deeper than intended sedation), and (2) determine whether monitoring with these parameters is associated with fewer alarm events.
RAM noninvasively and continuously measures respiration rate using an innovative adhesive sensor with an integrated acoustic transducer that is applied to the patient’s neck.
In the two-part study, published in the journal Anesthesia & Analgesia
Data were analyzed from 90 patients (44 standard and 46 advanced). There were 55% fewer alarm events in advanced patients compared with standard patients (median 2.5 vs. 5.5, p=0.038). Fewer advanced patients had ≥1 respiratory depression event (17 vs 26; p=0.035) or ≥1 desaturation event (15 vs 25; p=0.02).
The investigators also compared respiratory rate events between capnography (using the Covidien Capnostream™ 20p) and RAM in the standard group and conducted a retrospective analysis to determine the true positive rates for capnography and RAM. The true positive rates were 30% and 78% respectively; the false positive rates were 70% and 22% respectively.
There were no significant differences between groups in the number of deeper than intended sedation events using SedLine.
The authors concluded that “the use of advanced monitoring during planned moderate sedation was associated with fewer alarm events, patients experiencing desaturation, and patients experiencing respiratory depression alarm events. … The findings of this pilot study suggest that further study into the safety and outcome impacts of advanced monitoring during procedure-related sedation is warranted.”
For more information on RAM and SedLine, go to www.masimo.com.
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1 Applegate RL II, Lenart J, Malkin M, Meineke MN, Qoshlli S, Neumann M,
Jacobson JP, Kruger A, Ching J, Hassanian M, Um M. Advanced Monitoring
Is Associated with Fewer Alarm Events During Planned Moderate
Procedure-Related Sedation: A 2-Part Pilot Trial. Anesth Analg. 2016
This press release includes forward-looking statements as defined in
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934, in connection with the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements include, among others, statements regarding the potential
effectiveness of Masimo’s rainbow® Acoustic Monitoring (RAM™) and
SedLine® brain function monitoring technologies. These forward-looking
statements are based on current expectations about future events
affecting us and are subject to risks and uncertainties, all of which
are difficult to predict and many of which are beyond our control and
could cause our actual results to differ materially and adversely from
those expressed in our forward-looking statements as a result of various
risk factors, including, but not limited to: risks related to our
assumptions regarding the repeatability of clinical results; risks
related to our belief that
Irene Paigah, 858-859-7001