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BACKGROUND Patient monitoring devices are critical for alerting (84%), Life Scope (81%), Efficia (79%), ePM10 (77%), and Intelli-
of potential cardiac arrhythmias during hospitalization; however, Vue (75%). B125M raised 20 false alarms, which was significantly
there are concerns of alarm fatigue due to high false alarm rates. lower (P ,.0001) than iPM12 (284), Life Scope (292), IntelliVue
(304), ePM10 (324), and Efficia (493). The most common false
OBJECTIVE The purpose of this study was to evaluate the sensi- alarm was VT, followed by nonsustained VT.
tivity and false alarm rate of hospital-based continuous electrocar-
diographic (ECG) monitoring technologies. CONCLUSION We found significant performance differences among
multiparameter bedside ECG monitoring systems using previously
METHODS Six commonly used multiparameter bedside monitoring collected recordings. B125M had the highest sensitivity in detect-
systems available in the United States were evaluated: B125M (GE ing true VT events and lowest false alarm rate. These results can
HealthCare), ePM10 and iPM12 (Mindray), Efficia and IntelliVue assist in minimizing alarm fatigue and optimizing patient safety
(Philips), and Life Scope (Nihon Kohden). Sensitivity was tested us- by careful selection of in-hospital continuous monitoring technol-
ing ECG recordings containing 57 true ventricular tachycardia (VT) ogy.
events. False-positive rate testing used 205 patient-hours of ECG re-
cordings containing no cardiac arrhythmias. Signals from ECG re-
KEYWORDS Alarm fatigue; Electrocardiogram; Electrocardiographic
cordings were fed to devices simultaneously; high-severity
monitoring; False alarm; Outcomes; Sensitivity; Specificity; Ventric-
arrhythmia alarms were tracked. Sensitivity to true VT events and
ular tachycardia
false-positive rates were determined. Differences were assessed us-
ing Fisher exact tests (sensitivity) and Z-tests (false-positive rates).
(Cardiovascular Digital Health Journal 2024;-:1–8) © 2024 Heart
RESULTS B125M raised 56 total alarms for 57 annotated VT events Rhythm Society. This is an open access article under the CC BY-NC-
and had the highest sensitivity (98%; P ,.05), followed by iPM12 ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Introduction tient care, and the response rate of health care personnel is
Patient monitoring devices are a critical component of the dependent on the perceived credibility and accuracy of the
decision-making repertoire of health care personnel in caring systems.
for patients in the hospital environment, including directing Patient monitors are not intended to replace close observa-
the course of treatment and delivering lifesaving therapies. tion of the patient by clinical staff, but a monitor that alerts
Bedside and central stations display waveforms, including for a potential cardiac arrhythmia is a useful tool to assist staff
electrocardiograms (ECGs), pulse rate, noninvasive blood in monitoring patient conditions.1 Ventricular tachycardia (VT)
pressure, invasive hemodynamic pressures (eg, arterial, pul- is a common and dangerous arrhythmia that occurs during
monary artery, central venous, and intracranial), respiratory continuous ECG patient monitoring.2 Timely assessment and
rate, and peripheral oxygen saturation, among other parame- treatment of suspected VT is critical because untreated VT
ters. ECG signals are the primary method for real-time moni- can result in severe, and in some cases fatal, complications.
toring of patient cardiac rhythm. The visual and auditory High VT burden can lead to syncope, electrical storm, cardio-
alarms created by these monitors play an integral part in pa- genic shock, and cardiac arrest, and up to 10% of sustained VTs
may degenerate into ventricular fibrillation (VF).3–5 Additional
Address reprint requests and correspondence: Dr John W. Beard, GE
arrhythmias that require active monitoring include VF,
HealthCare, 500 W Monroe St, Chicago, IL 60661. E-mail address: John. nonsustained ventricular tachycardia (NSVT), accelerated
Beard@ge.com. ventricular rhythm, and asystole. Therefore, ventricular
2666-6936/© 2024 Heart Rhythm Society. This is an open access article under the CC BY-NC-ND https://doi.org/10.1016/j.cvdhj.2024.02.002
license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
2 Cardiovascular Digital Health Journal, Vol -, No -, - 2024
had data from at least 4 leads collected: leads I, II, and III care providers to respond and thereby could contribute to
were always collected, and additional data were collected alarm fatigue if raised erroneously. These included VT,
from either lead V1 or lead V5. The recordings had abnormal VF/VT, NSVT, accelerated ventricular rhythm, asystole,
morphology on ECG, such as small QRS, high T-wave or P- and ventricular beat runs (VRUN). The criteria for each
wave, conduction abnormalities, significant damage caused alarm type are given in Supplemental Table 2; false alarms
by MI, or significantly noisy ECGs caused by patient move- were tracked separately by type. All “ventricular run” alarms
ment. These recordings did not include any significant VT that included .2 ventricular beats in a row with a heart rate
events, according to hospital patient records. The original re- above the ventricular bradycardia threshold were included.
cordings were 24 hours long, but because of time limitations Alarms that were not turned on as part of the default settings
for testing, only the first 5 hours of data was used for testing, on each device (ie, those that were optional) were not
resulting in a total of 205 hours of testing. Due to the retro- included.
spective nature of this study and the use of fully anonymized
data, formal ethical approval and informed consent were not Testing protocol
required. This study was conducted according to the ethical
Digitized signals from the datasets of ECG recordings were
principles of the Declaration of Helsinki on the use of human
converted to electric signals using a “data playback device.”
data.
All monitors were connected to the “data playback device” at
the same time using their own lead wires simulating the pa-
Test setup tient. The devices used the beginning of each record as a
All monitors were configured to their default settings, and the learning period, which was excluded from the analysis. For
VT and asystole criteria were set as close to identical as sensitivity testing, the recordings with true VT events were
possible (Table 2). The VT criteria were set to 6 premature fed to the devices simultaneously, alarm notifications were
ventricular contractions in all but the Life Scope (set to 9) collected from the event histories of each device, and then
because it did not allow changing the value without adminis- alarms were compared to the reference annotations on true
trative privileges that were not available during the test. VT VT events. We note that in addition to VT events, the
rate was 100 for all the monitors. Asystole duration was set B125M has VF alarms labeled as “VF/VT” because VF
to 5 seconds in all but the IntelliVue, which was set to its events may also have sections of VT. Therefore, the VT/
maximum value of 4 seconds. QRS threshold settings were VF and the VF alarms given by other devices were classified
not modified from the default values (Table 2). as correct VT alarms for comparison. For false-positive
testing, the false alarm recordings were fed to devices simul-
Tracked alarms taneously and alarm notifications were collected to determine
We tracked alarms for arrhythmias that would be considered the number of false alarms. If .1 similar false alarm occurred
potentially life-threatening events and would trigger a high within 3 seconds, they were calculated as 1 alarm only to
severity alarm by all the monitors. Selecting alarms based most accurately count unique alarm events when a small
on level of severity allowed us to track those alarms that gap (of approximately 1 correctly classified normal beat)
would be expected to contribute the largest burden on health was present between false alarm runs.
Statistical analysis est sensitivity and the lowest false alarm rate of all monitors
The sensitivity of each device was calculated by dividing the tested. The iPM12 and Life Scope had the second and third
number of correct alarms by the total number of true VT highest sensitivity and lowest false alarm rate, respectively.
events. Non-VT alarms for VT events were counted sepa- The IntelliVue had the lowest sensitivity of all 6 monitoring
rately to acknowledge the clinical response and potential devices under study; the Efficia had the highest false-positive
intervention that a non-VT alarm would trigger, prompting rate.
the health care personnel to check the status of the patient.
The false-positive rate was computed by dividing the number Sensitivity
of false alarms by the total testing time of 205 hours. An The B125M raised 56 total alarms for 57 investigated VT
approach in which false alarms (False Positives) were events for sensitivity of 98% (Table 3). Of these alarms, 49
compared to True Negative events was not applicable in were true VT alarms and 7 were non-VT alarms (3 AV and
this context, as True Negatives cannot meaningfully be 4 NSVT). The iPM12 had the second-highest sensitivity
defined when monitoring and analyzing continuous signals. (84%); it raised 31 true VT alarms and 17 non-VT alarms
Sensitivity is reported as percentage, with odds ratios (OR) (15 NSVT and 2 VRUN). The Life Scope raised true VT
and 95% confidence interval (CI). Comparisons of sensitiv- alarms for 19 events and VRUN alarms for the other 27
ities were carried out using the “exact 2!2” package in R alarmed VT events. We note that the Life Scope’s true VT
Version 3.4.3 (R Foundation for Statistical Computing, alarm rates were not directly comparable to other monitors
Vienna, Austria). because of its less sensitive setting in VT length. The Efficia
In order to make statistical comparisons of performance, had the next-highest sensitivity (79%), alarming 45 of 57 VT
one of the devices was selected to serve as the referent group. events with no non-VT alarms. The ePM10 raised 33 VT and
We selected the most recently approved of the study devices 11 non-VT alarms (8 NSVT and 3 VRUN). The IntelliVue
as the basis for comparisons (B125M), but the referent group had the lowest sensitivity to VT events, raising alarms for
was not used outside of these statistical comparisons or as a 43 of 57 events (75%) with no non-VT alarms. Data analysis
standard for determining correct or false annotations. The indicated that the sensitivity of the B125M was significantly
false-positive rate ratio was calculated as the ratio of the higher than all study comparators (P ,.05).
false-positive rate for each device to the false-positive rate
of the referent group. The 95% CI of the false-positive rate False alarms
ratio was calculated based on the distribution of the log- The B125M generated the lowest (P ,.0001) number of false
transformed rate ratio, which was approximately normal. alarms (20), of which the majority (52%) were NSVT alarms
To detect statistically significant differences, Fisher exact (Tables 4 and 5). The iPM12 generated 284 false alarms, fol-
tests were used for sensitivities and Z-tests were used for lowed by the Life Scope with 292 alarms. The IntelliVue and
false-positive rates. P ,.05 was considered significant. Com- the ePM10 had a moderate number of false alarms (304 and
parisons of false-positive rates and tests for significance were 324, respectively), and the Efficia had the highest number of
performed using SAS Version 9.4 (SAS Institute Inc., Cary, false alarms (494). False alarms raised by the IntelliVue and
NC). the Efficia were almost exclusively VT alarms (97% and
96%, respectively).
Results In considering the distribution of the false alarms accord-
In total, the sensitivity testing used data from 29 patients with ing to their cases, 4 recordings were responsible for the ma-
57 true VT events that resulted in 338 cumulative alarms jority of alarms (Figure 1). These were particularly noisy
from the 6 monitors. The false alarm testing used 5 hours recordings with a consistently low signal-to-noise ratio that
of data from each of 41 patients for 205 patient-hours of re- had been selected to challenge the monitors. The false alarms
cordings, which generated 1717 total false alarms across all did not occur within a certain short episode in each of these
6 monitors. Our analyses indicated that different systems recordings but were widely distributed across the total
had statistically significant differences in sensitivity and recording time.
false-positive rates that may inform the choice of technology Combined examination of sensitivity and false alarm rate
for patient monitoring. The B125M displayed both the high- revealed that 4 of the examined devices had similar overall
Table 4 False-positive rate analysis and false-positive rates that may inform the choice of technol-
False alarm
ogy for patient monitoring.
Device count FPR* FPR ratio† (95% CI) P value† The B125M monitor had the highest sensitivity (98%). It
alarmed 56 of 57 VT events during the testing period, and 49
B125M 20 0.10 — of the alarms were correctly labeled as VT. This sensitivity is
ePM10 324 1.58 16.20 (10.31–25.45) ,.0001
iPM12 284 1.39 14.20 (9.02–22.35) ,.0001 comparable to the 97% achieved in a recent report of a ma-
Life Scope 292 1.42 14.60 (9.28–22.97) ,.0001 chine learning–based algorithm for classification of VT.18
Efficia 493 2.40 24.65 (15.76–38.55) ,.0001 The other 5 monitors had variable but still moderately high
IntelliVue 304 1.48 15.20 (9.67–23.90) ,.0001 sensitivity, ranging from 75%–84%. All monitors except
FPR 5 false-positive rate; FPR ratio 5 ratio of the false-positive rate for the IntelliVue and Efficia had a proportion of non-VT alarms
each device to the false-positive rate of the referent group. triggered for VT events, which may be associated with a
*Count per person per hour. slower reaction of the health care personnel. However, these
†
B125M was used as the standard for comparisons.
alarms, although not correctly labeled, will likely achieve the
desired outcome by capturing the attention of the health care
provider, triggering assessment of the patient. Timely detec-
performance, clustered at the center of the plot: iPM12, Life
tion and treatment of cardiac arrhythmia are essential for pa-
Scope, IntelliVue, and ePM10 (Figure 2). These devices had
tient monitoring given the potentially severe impact of
moderate sensitivities (75%–84%) and false-positive rates
undetected events on patient outcomes. Ventricular arrhyth-
around 1.5 events per patient per hour. The Efficia and
mias are major complications associated with poor in-
B125M devices were removed from this central cluster
hospital and long-term outcomes, including increased mor-
because the Efficia had a higher false-positive rate (2.40
tality.19–21
events per person per hour) that moved it to the right of the
The monitors also performed differently in terms of the
plot, and the B125M had a lower false-positive rate and
number of false alarms raised during the 205-hour testing
higher sensitivity, bringing it closest to the ideal monitoring
period. The B125M had the lowest with 20 false alarms,
system at the top left of the plot. The ideal patient monitoring
which was strikingly lower than other study devices:
system has 0 false alarms and 100% sensitivity.
iPM12 (284), Life Scope (292), IntelliVue (304), ePM10
(324), and Efficia (493). The majority of these rates align
with estimates suggesting that nurses are responsible for re-
Discussion sponding to 150–400 alarms per patient per day.22,23 In
To the best of our knowledge, this is the first study to contrast, the B125M may significantly lower the false-
compare the sensitivity and false-positive rate of the ECG al- alarm response burden, with its rate of 2.4 alarms per patient
gorithms of 6 multiparameter bedside systems that are per day (0.10 per patient per hour), as measured in this study.
commonly used in clinical practice for in-hospital continuous High alarm counts are an important consideration in patient
patient monitoring to detect serious cardiac ventricular ar- care management because they are associated with large in-
rhythmias. We used a large sample of VT event recordings creases in subjective nurse-reported workload that should
annotated by independent, expert cardiologists while manag- be minimized where possible.24 The most common type of
ing patients with a history of acute MI to test sensitivity, re- false alarm varied by device and was more likely to occur
sulting in highly controlled and interpretable data output. The during recordings that were particularly noisy or complex.
monitors were challenged with .200 hours of difficult re- This aligns with previous research that has shown ECG
cordings to assess false alarms, a critically important perfor- signal corruption can be due to a variety of sources, including
mance characteristic in our current era of safety concerns muscle artifact, baseline wander, instrumentation noise, and
surrounding alarm fatigue. Our results indicate that distinct power line interference, all of which can lead to false
systems have statistically significant differences in sensitivity alarms.25,26 Although certain false alarms may be less
Figure 1 Distribution of false alarms in each record, across all devices. Each color represents the number of false alarms in 1 record across all the devices.
Labeled bars indicate the 4 recordings with the greatest number of false alarms across all devices.
meaningful in the context of signal noise, such as false alarms from the American Heart Association stipulate that 2 or pref-
for asystole, these alarms still would be expected to erably 3 or more leads should be displayed and monitored
contribute to the burden on health care providers when they simultaneously,28 as using multiple leads can increase the
occur in clinical practice and so were tracked accordingly sensitivity of the algorithm because the QRS amplitude can
in our study. be low in only 1 lead but normal in others, or the obviousness
The hardware and software of these medical devices are of ventricular beats can be more pronounced in a single lead
complex, and the details are not publicly available. However, but have only minor morphologic changes in other leads. In
there are distinctions among the devices that may explain previous research, greater number of ECG leads has been
some of our results. For example, the B125M uses simulta- associated with increased sensitivity and retainment of high
neous 4-lead analysis, compared to 2- or 3-lead algorithms specificity in the detection of a range of adverse cardiac
commonly used in the other devices.27 Recommendations events.12–15 Therefore, algorithms that use more leads
Figure 2 Combined representation of sensitivity and false alarm rate. The ideal monitoring system is shown as the green dot at the top left.
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