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Anesth Analg 2011 Schmid 78 83

Anesth Analg 2011 Schmid 78 83

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The Wolf Is Crying in the Operating Room: PatientMonitor and Anesthesia Workstation AlarmingPatterns During Cardiac Surgery
Felix Schmid, MD,* Matthias S. Goepfert, MD,* Daniela Kuhnt,† Volker Eichhorn, MD,*Stefan Diedrichs, MD,* Hermann Reichenspurner, MD, PhD,‡ Alwin E. Goetz, MD, PhD,*and Daniel A. Reuter, MD, PhD*
BACKGROUND:
Vital sign monitors and ventilator/anesthesia workstations are equipped withmultiple alarms to improve patient safety. A high number of false alarms can lead to a “cryingwolf” phenomenon with consecutively ignored critical situations. Systematic data on alarmpatterns and density in the perioperative phase are missing. Our objective of this study was tocharacterize the patterns of alarming of a commercially available patient monitor and aventilator/anesthesia workstation during elective cardiac surgery.
METHODS:
We performed a prospective, observational study in 25 consecutive elective cardiacsurgery patients. In all patients, identically fixed alarm settings were used. All incoming patientdata and all alarms from the patient monitor and the anesthetic workstation were digitally recorded. Additionally, the anesthesia workplace was videotaped from 2 different angles to allowretrospective annotation and correlation of alarms with the clinical situation and assessment of the anesthesiologists’ reaction to the alarms.
RESULTS:
Of the 8975 alarms, 7556 were hemodynamic alarms and 1419 were ventilatory alarms. For each procedure, 359
Ϯ
158 alarms were recorded, representing a mean density of alarms of 1.2/minute.
CONCLUSION:
Approximately 80% of the total 8975 alarms had no therapeutic consequences.Implementation of procedure-specific settings and optimization in artifact and technical alarmdetection could improve patient surveillance and safety. (Anesth Analg 2011;112:78–83)
T
he use of alarming systems in patient monitoringdevices, such as ventilator/anesthesia workstations,is of paramount importance for patient safety. Thisaccounts for both perioperative anesthesia and monitoringin the intensive care unit (ICU). Inadequate use or failure torespond to intraoperative alarms may result in patienthazard and undesirable outcomes.
1,2
The majority of alarms are so-called threshold alarms, i.e., a violation of apredefined threshold leads to an acoustic and/or opticalalarm. Therefore, it is crucial to set alarming thresholdscorrectly. Thresholds have to be tight enough to detectpotential deteriorations in vital functions as early as pos-sible. However, tight thresholds are naturally prone to ahigh number of false-positive alarms. Therefore, con-versely, they have to be set wide enough to account forphysiologic inter- and intrapatient variations. In addition,artifacts (e.g., patient movement or manipulation of sen-sors) may lead to false-positive alarms. Depending on thesurgical procedure, differing patterns and frequencies of alarms have been described.
3
For the situation in theoperating room (OR), the rate of false alarms was describedto even exceed the number of correct alarms, so that theactual function of the alarms was lost and they became adistraction.
3
Furthermore, studies in different adult andpediatric ICUs found false alarm rates ranging from 72% to99%.
3–6
The dangerous consequence is the “crying wolf phenomenon,i.e., that because of the density of totalalarms and the high number of false alarms, correct andimportant alarms are ignored.
4
Thus, an important goal, inparticular for clinical situations with high-risk procedures,is to reduce false alarm rates to a minimum by an opti-mized setting of alarm thresholds. However, there are onlyfew data on quantity and quality of alarming in a complexperioperative setting.Therefore, this study was performed to characterize thepatterns of alarms of a current patient monitor (Kappa XLT;Dra¨ger, Lu¨beck, Germany) and an anesthesia workstation(Zeus, Dra¨ger) during elective cardiac surgery with the useof extracorporeal circulation (ECC). The objective was toquantify and to characterize all occurring alarms includingidentification of their origin during the entire perioperativephase. Furthermore, we sought to quantify the number of false-positive alarms produced by the monitoring system.
METHODS
The protocol of this observational study was approved andauthorized by the local ethics committee, the IRB, and theprivacy protection commissioner of the hospital. Afterproviding informed consent, 25 consecutive patients sched-uled for elective cardiac surgery (aortocoronary bypassgrafting and valve surgery) were included. Perioperativecare was given by an anesthesiologist who was informed of 
From the Departments of *Anesthesiology, and ‡Cardiovascular Surgery,University Medical Center Hamburg-Eppendorf, Hamburg; and †HochschuleAnhalt, Ko¨then, Germany.Accepted for publication August 30, 2010.Supported by an unrestricted grant from Dra¨ger, Lu¨beck, Germany.FS and MSG contributed equally to this work.The authors report no conflicts of interest.Address correspondence and reprint requests to Daniel A. Reuter, MD,PhD, Department of Anesthesiology, Hamburg-Eppendorf UniversityHospital, Martinistr. 52, 20246 Hamburg, Germany. Address e-mail todreuter@uke.de.Copyright © 2010 International Anesthesia Research Society
DOI: 10.1213/ANE.0b013e3181fcc504
78
www.anesthesia-analgesia.org January 2011
Volume 112
Number 1
 
 being videotaped but blinded to the aims of the study. Allcaregiving anesthesiologists were staff anesthesiologists orresidents in their last year.All patients were premedicated with 7.5 to 15 mg midazo-lam per os 1 hour before arrival in the OR. According to theinstitutional standards, induction of anesthesia was per-formed with sufentanil 0.7
g/kg and etomidate 0.15 mg/kg.Tracheal intubation was facilitated by pancuronium 0.1mg/kg. Patients’ lungs were mechanically ventilated involume-controlled mode (autoflow) with tidal volumes of 8mL/kg, and a ventilatory frequency of 8 to 12 breaths/min(Zeus,Dra¨ger).Anesthesiawasmaintainedbyisoflurane0.5%to 1.0% and by sufentanil up to a dose of 0.7
g/kg/h.All patients were monitored with the same combina-tion of patient monitor (Kappa XLT, Dra¨ger) and anes-thesia workstation (Zeus, Dra¨ger). Monitoring includedelectrocardiogram and pulse oximetry. Furthermore, ar-terial blood pressure was measured invasively in 1 radialartery. Central venous pressure was continuously ob-tained with a central venous catheter in the right internal jugular vein. Bladder temperature was measured continu-ously. In addition, all ventilation data, i.e., respiratory rate,airway pressures, tidal volume, and inspiratory and expi-ratory concentration of carbon dioxide and isoflurane, weremonitored by the anesthesia workstation. In the perioper-ative phase, all patients were repeatedly assessed by trans-esophageal echocardiography.After initiation of monitoring and induction of anesthe-sia, patients were transferred to the OR and connected tothe anesthesia workstation and the patient monitor. Bothdevices were directly connected to a laptop computer fordigital data storage in dedicated full-disclosure files usingspecial software (MedLink, Nortis, Lu¨beck, Germany andeData TapeRec, Erasmus MC, Rotterdam, The Nether-lands). The data collection started at the moment of arrivalin the OR. The following data were recorded with asampling interval of 1 second: all numerical measurementsof the patient monitor and the anesthesia workstation, allreal-time waveforms of pressures and flow readings, andall alarm events that were generated by both devices. Inparallel, video recordings of the anesthesia workplace from2 different views were performed during the study (Fig. 1).Therefore, all reactions of the attending physician to up-coming alarms could be registered and annotated. All datafrom the patient monitor, the anesthesia workstation, andthe video cameras were time stamped, allowing an exactsynchronization of all stored data.Fixed alarm settings were used for all patients (Table 1).The caregiving anesthesiologist was instructed not tochange this setting. During ECC, only the mean arterial blood pressure alarm and the body temperature alarmwere active; all other alarms were deactivated. Immedi-ately after ECC, all alarms were reactivated according tothe fixed alarm settings. Only the thresholds for thealarm “heart rate” were changed to 70 bpm (lower limit)and 110 bpm (upper limit), because of postoperativepacemaker use.The stored information of each alarm consisted of thealarm grade, the parameter causing the alarm, and the alarmmessage. The alarm grade indicated whether the alarm wasan advisory alarm (low priority), a serious alarm (mediumpriority), or a life-threatening alarm (high priority). Advisoryalarms indicated technical problems, such as a disconnec-tion of a sensor. Serious alarms were caused by a violationof thresholds. Life-threatening alarms were triggered only by arrhythmias such as ventricular tachycardia, ventricularfibrillation, or asystole. Furthermore, a so-called “staticalarm” for the invasive arterial blood pressure monitoringwas registered. A static blood pressure alarm is generatedif the height of the amplitude of the arterial pulse pressuremeasured invasively is
Ͻ
3 mm Hg. This is normally used torecognize a potential damping of the signal or a disconnec-tion of the arterial catheter. The principle of using aminimum amplitude to exclude technical problems with apulsating signal is not limited to only this monitor. It is alsoused frequently in pulse oximetry or capnometry to detectpatient disconnection.After completion of data collection, all data were anno-tated by the same anesthesiologist. Every single alarm wasanalyzed on the basis of the numerical measurements, thedigitalized waveforms, and the respective video sequence.Based on this, all recorded alarms were categorized asfollows: “technically true/technically false,” “clinicallyrelevant/not clinically relevant,” and “medical reaction:yes/no.” Alarms were categorized as technically true if the
Figure 1.
Views of the video cameras in the operating room inrelation to the anesthesia and surgical workplace.
Table 1. Standardized Fixed Alarm Settings
VariableHR
ECG
(beats/min)Lower limitPre-ECC: 50Post-ECC: 70Upper limitPre-ECC: 90Post-ECC: 110
Pulse Sp
O
2
(beats/min) 50 90SAP (mm Hg) 80 150MAP (mm Hg) 40 90DAP (mm Hg) 40 80CVP (mm Hg) 0 15LAP (mm Hg) 5 20Sp
O
2
(%) 93 100T
bladder
(°C) 35.0 38.5MV (L/min) 3 12RR (breaths/min) 6 20Paw (mbar) 5 30CO
2 exp
(mm Hg) 30 40CO
2 insp
(mm Hg) 5Isoflurane
insp
(%) 1.3 2.0Isoflurane
exp
(%) 0.5 1.3
ECC
ϭ
extracorporeal circulation; HR
ECG
ϭ
heart rate electrocardiogram;pulse Sp
O
2
ϭ
pulse rate measured by pulse oximetry; SAP
ϭ
systolic arterialpressure; MAP
ϭ
mean arterial pressure; DAP
ϭ
diastolic arterial pressure;CVP
ϭ
central venous pressure; LAP
ϭ
left atrial pressure; Sp
O
2
ϭ
oxygensaturation measured by pulse oximetry; MV
ϭ
minute ventilation; RR
ϭ
respiratory rate; Paw
ϭ
airway pressure; CO
2 exp
ϭ
expiratory CO
2
content;CO
2 insp
ϭ
inspiratory CO
2
content; isoflurane
insp
ϭ
inspiratory isofluraneconcentration; isoflurane
exp
ϭ
expiratory isoflurane concentration; T
bladder
ϭ
bladder temperature.
January 2011
Volume 112
Number 1 www.anesthesia-analgesia.org
79
 
measurement was technically correct (without artifacts)and showed a real threshold violation. Alarms were anno-tated as clinically relevant if there was a need for medicalintervention. Patient-related alarms were caused by vari-ables of the patients’ vital sign monitoring (without “staticalarms” [Fig. 2]). The annotating anesthesiologist recordedwhether or not a medical reaction was performed after analarm occurred. In uncertain situations, the particular videosequences were reanalyzed by a panel of 3 attendingphysicians.Every onset of an alarm was counted and every alarmwas counted only once even though the sound continuedfor a longer time. If an alarm was silenced and appearedagain after the 2 minutes, it was counted again.Data were analyzed using the software R(http://www.r-project.org/) and Excel 2003 (MicrosoftCorp., Redmond, WA). Normal distribution of data wastested with the Kolmogorov-Smirnov test. Normally dis-tributed variables are expressed as mean
Ϯ
SD, otherwiseas median (25th–75th percentile).
RESULTS
Twenty-five patients (14 men, 11 women) were studied.The mean age was 67
Ϯ
11.4 years. Twelve patientsunderwent arterio-coronary bypass surgery, 11 valvularsurgery, and 2 patients had a combination of both. TheeuroSCORE at time of admission to the hospital was 4.7
Ϯ
3.
7
The duration of surgery was 4.95
Ϯ
0.96 hours.One hundred twenty-four hours of intraoperative moni-toring were recorded. In total, 8975 alarms were recorded.There were 7556 hemodynamic alarms and 1419 ventilatoryalarms. This accounted for 359
Ϯ
158 alarms per procedure,or 1.2 alarms per minute. The overall reaction time (timefrom occurrence to confirmation) to the alarms amountedto 4
Ϯ
43.67 seconds. In this observation, we found 6386serious and life-threatening alarms, which were furtheranalyzed. The remaining 2589 alarms belonged to thecategory advisory technical alarms (
n
ϭ
836) or were “static blood pressure alarms” (
n
ϭ
1753) during ECC (see below).Ninety-six percent of the serious and life-threateningalarms were caused by threshold violations (Table 2). Of those alarms, 4438 (70%) were valid, whereas 1948 (30%)were caused by artifacts and were not valid or relevant. Of the valid alarms, 1735 (39%) were classified as relevant, and2703 (61%) were not relevant.In all patients, ECC was used. For analysis, all proce-dures were separated into 5 phases: “pre-ECC,” “going onECC” (last 15 minutes before start of ECC), “during ECC,”“weaning from ECC” (first 15 minutes after cessation of ECC), and “post-ECC.” During “pre-ECC” we found 2985alarms (33%) with a density of 1.4 alarms/min. During“going on ECC,we observed 930 (10%), or 2.5alarms/min. In the phase “during ECC,” 3114 alarms (35%)with a density of 0.9 alarms/min were registered. During“weaning from ECC” 626 alarms (7%) with a density of 1.7
 Active Alarmsn= 8975
Patient related alarmsn=6386
Other alarmsn=2589
Technically falsen=1948Technically truen=4438Technical alarmsn=836Static alarmsn=1753
   l   i  n   i  c  a   l   l  y  n  o   t  r  e   l  e  v  a  n   t  n  =   1   9   4   8   P  a   t   i  e  n   t  m  o  n   i   t  o  r  n  =   5   4   1   l   i  n   i  c  a   l   l  y  n  o   t  r  e   l  e  v  a  n   t  n  =   2   7   0   3  e  s   t   h  e  s   i  a  w  o  r   k  s   t  a   t   i  o  n  n  =   2   9   5   C   l   i  n   i  c  a   l   l  y  r  e   l  e  v  a  n   t  n  =   1   7   3   5
 
   C C   A
Figure 2.
Differentiation of active alarms in“patient-related alarmsand “other alarms.”Patient-related alarms were caused by variables of the patient monitoring (e.g., invasive arterial bloodpressure and oxygen saturation). Patient-relatedalarms are further separated in “technically true” or“technically false,” and “clinically relevant” and“not relevant.”
Table 2. Number of Threshold Violations, Sortedby Numbers of Total Violations
VariableLower limitviolationUpper Limitviolation Total %
MAP 739 946 1685 27.5HR
ECG
371 495 866 14.2SAP 554 117 671 11.0DAP 395 160 555 9.1CVP 240 290 530 8.7V
T
0 448 448 7.3CO
2 exp
284 20 304 5.0Pulse Sp
O
2
92 166 258 4.2Sp
O
2
120 0 120 2.0Paw 0 111 111 1.8LAP 64 18 82 1.3T
bladder
74 0 74 1.2Others 165 250 415 6.8Total 3098 3021 6119 100
MAP
ϭ
mean arterial pressure; HR
ECG
ϭ
heart rate electrocardiogram; SAP
ϭ
systolic arterial pressure; DAP
ϭ
diastolic arterial pressure; CVP
ϭ
centralvenous pressure; V
T
ϭ
tidal volume; CO
2 exp
ϭ
expiratory CO
2
content; pulseSp
O
2
ϭ
pulse rate measured by pulse oximetry; Sp
O
2
ϭ
oxygen saturationmeasured by pulse oximetry; Paw
ϭ
airway pressure; LAP
ϭ
left atrialpressure; T
bladder
ϭ
bladder temperature; others
ϭ
inspiratory CO
2
content,inspiratory isoflurane concentration, expiratory isoflurane concentration, STdeviations (STI, STII, STIII, STV, STaVR, STaVL, STaAVF).
Monitoring Alarms in Cardiac Surgery
80
www.anesthesia-analgesia.org
ANESTHESIA & ANALGESIA

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