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Epilepsia Jan 2017Sudden unexplained death in epilepsy (SUDEP) during inpatient electroencephalography (EEG) monitoring has been a rare but potentially preventable event, with associated...
OBJECTIVE
Sudden unexplained death in epilepsy (SUDEP) during inpatient electroencephalography (EEG) monitoring has been a rare but potentially preventable event, with associated cardiopulmonary markers. To date, no systematic evaluation of alarm settings for a continuous pulse oximeter (SpO ) has been performed. In addition, evaluation of the interrelationship between the ictal and interictal states for cardiopulmonary measures has not been reported.
METHODS
Patients with epilepsy were monitored using video-EEG, SpO , and electrocardiography (ECG). Alarm thresholds were tested systematically, balancing the number of false alarms with true seizure detections. Additional cardiopulmonary patterns were explored using automated ECG analysis software.
RESULTS
One hundred ninety-three seizures (32 generalized) were evaluated from 45 patients (7,104 h recorded). Alarm thresholds of 80-86% SpO detected 63-73% of all generalized convulsions and 20-28% of all focal seizures (81-94% of generalized and 25-36% of focal seizures when considering only evaluable data). These same thresholds resulted in 25-146 min between false alarms. The sequential probability of ictal SpO revealed a potential common seizure termination pathway of desaturation. A statistical model of corrected QT intervals (QTc), heart rate (HR), and SpO revealed close cardiopulmonary coupling ictally. Joint probability maps of QTc and SpO demonstrated that many patients had baseline dysfunction in either cardiac, pulmonary, or both domains, and that ictally there was dissociation-some patients exhibited further dysfunction in one or both domains.
SIGNIFICANCE
Optimal selection of continuous pulse oximetry thresholds involves a tradeoff between seizure detection accuracy and false alarm frequency. Alarming at 86% for patients that tend to have fewer false alarms and at 80% for those who have more, would likely result in a reasonable tradeoff. The cardiopulmonary findings may lead to SUDEP biomarkers and early seizure termination therapies.
Topics: Adolescent; Adult; Aged; Drug Resistant Epilepsy; Electrocardiography; Electroencephalography; Female; Heart Rate; Humans; Longitudinal Studies; Male; Middle Aged; Monitoring, Physiologic; Oximetry; Respiration; Retrospective Studies; Young Adult
PubMed: 27864903
DOI: 10.1111/epi.13606 -
Journal of Clinical Monitoring and... Aug 2022The contemporary practice of monitoring physiologic parameters in the critical care setting is based on alarm systems with high sensitivity but low specificity. A...
The contemporary practice of monitoring physiologic parameters in the critical care setting is based on alarm systems with high sensitivity but low specificity. A natural consequence of this approach is a massive amount of alarms, which potentially leads to fatigue in the personnel and negatively impacts the quality of care provided. The study objective is to determine the prevalence, types, and determinants of alarms in a neurological critical care unit (NCCU) prototype. During a one-month period corresponding to 272 days of monitoring in 34 patients, nursing staff recorded the type and number of sounding alarms in a university NCCU. Alarms were categorized into three types as type-A alarms that were merely handled by the nursing staff, type-B alarms that were primarily managed by nurses, but the physician was also notified, and type-C alarms that were principally handled by NCCU physicians. There were a total of 9439 alarms, with an average of daily 34.7 alarms per bed, corresponding to one alarm every 41.4 min. Most of the alarms were type-A (57.7%), followed by type-B (39.2%) and type-C (3.1%) alarms. Alarms originated from electrocardiogram (34.6%), pulse oximeter (33.7%), noninvasive blood pressure monitoring (9.8%), respiratory monitoring (9.7%), intravenous fluid pumps (4.5%), ventilator (3.9%), enteral pumps (2.1%) and invasive blood pressure systems (1.7%). A noticeable diurnal variation was observed for type-A pulse oximeter, type-A and -B ECG alarms (increase during morning shifts), and type-A ventilator alarms (decrease during morning shifts). Alarms are highly prevalent in NCCUs and can correspond to an important portion of the workload.
Topics: Clinical Alarms; Critical Care; Humans; Intensive Care Units; Monitoring, Physiologic; Oximetry; Prospective Studies
PubMed: 34043136
DOI: 10.1007/s10877-021-00724-x -
JMIR Research Protocols Jun 2018The variety of alarms from all types of medical devices has increased from 6 to 40 in the last three decades, with today's most critically ill patients experiencing as...
BACKGROUND
The variety of alarms from all types of medical devices has increased from 6 to 40 in the last three decades, with today's most critically ill patients experiencing as many as 45 alarms per hour. Alarm fatigue has been identified as a critical safety issue for clinical staff that can lead to potentially dangerous delays or nonresponse to actionable alarms, resulting in serious patient injury and death. To date, most research on medical device alarms has focused on the nonactionable alarms of physiological monitoring devices. While there have been some reports in the literature related to drug library alerts during the infusion pump programing sequence, research related to the types and frequencies of actionable infusion pump alarms remains largely unexplored.
OBJECTIVE
The objectives of this study protocol are to establish baseline data related to the types and frequency of infusion pump alarms from the B. Braun Outlook 400ES Safety Infusion System with the accompanying DoseTrac Infusion Management Software.
METHODS
The most recent consecutive 60-day period of backup hospital data received between April 2014 and February 2017 from 32 United States-based hospitals will be selected for analysis. Microsoft SQL Server (2012 - 11.0.5343.0 X64) will be used to manage the data with unique code written to sort data and perform descriptive analyses. A validated data management methodology will be utilized to clean and analyze the data. Data management procedures will include blinding, cleaning, and review of existing infusion data within the DoseTrac Infusion Management Software databases at each hospital. Patient-identifying data will be removed prior to merging into a dedicated and secure data repository. This pooled data will then be analyzed.
RESULTS
This exploratory study will analyze the aggregate alarm data for each hospital by care area, drug infused, time of day, and day of week, including: overall infusion pump alarm frequency (number of alarms per active infusion), duration of alarms (average, range, median), and type and frequency of alarms distributed by care area.
CONCLUSIONS
Infusion pump alarm data collected and analyzed in this study will be used to help establish a baseline of infusion pump alarm types and relative frequencies. Understanding the incidences and characteristics of infusion pump alarms will result in more informed quality improvement recommendations to decrease and/or modify infusion pump alarms, and potentially reduce clinical staff alarm fatigue and improve patient safety. .
REGISTERED REPORT IDENTIFIER
RR1-10.2196/10446.
PubMed: 29903696
DOI: 10.2196/10446 -
American Family Physician Jan 2021
Review
Topics: Behavior Therapy; Child; Child, Preschool; Clinical Alarms; Conditioning, Classical; Female; Humans; Male; Nocturnal Enuresis; Treatment Outcome
PubMed: 33382553
DOI: No ID Found -
BMJ Open Quality Oct 2023High rates of medical device alarms in hospitals are a well-documented threat to patient safety. Little is known about organisational features that may be associated...
BACKGROUND
High rates of medical device alarms in hospitals are a well-documented threat to patient safety. Little is known about organisational features that may be associated with nurses' experience of alarm burden.
AIMS
To evaluate the association between nurse-reported alarm burden, appraisals of patient safety, quality of care and hospital characteristics.
METHODS
Secondary analysis of cross-sectional survey data from 3986 hospital-based direct-care registered nurses in 213 acute care hospitals in New York and Illinois, USA. We evaluated associations of alarm burden with appraisals of patient safety and quality of care and hospital characteristics (work environment, staffing adequacy, size, teaching status) using χ tests.
RESULTS
The majority of respondents reported feeling overwhelmed by alarms (83%), delaying their response to alarms because they were unable to step away from another patient/task (76%), and experiencing situations where a patient needed urgent attention but no one responded to an alarm (55%). Nurses on medical-surgical units reported these experiences at higher rates than nurses working in intensive care units (p<0.001). Alarm burden items were significantly associated with poorer nurse-reported patient safety, quality of care, staffing and work environment. Findings were most pronounced for situations where a patient needed urgent attention but no one responded to the alarm, which was frequently/occasionally experienced by 72% of those who rated their hospital's safety as poor versus 38% good, p<0.001; 80% who rated overall quality of care poor/fair versus 46% good/excellent, p<0.001 and 65% from poor work environments versus 42% from good work environments, p<0.001.
CONCLUSION
Most nurses reported feeling overwhelmed by medical device alarms, and our findings suggest that alarm burden may be more pronounced in hospitals with unfavourable working conditions and suboptimal quality and safety. Because this was a cross-sectional study, further research is needed to explore causal relationships and the role of modifiable systems factors in reducing alarm burden.
Topics: Humans; Cross-Sectional Studies; Intensive Care Units; Working Conditions; Hospitals; Nursing Care
PubMed: 37880160
DOI: 10.1136/bmjoq-2023-002342 -
The Cochrane Database of Systematic... May 2020Enuresis (bedwetting) affects up to 20% of five-year-olds and can have considerable social, emotional and psychological effects. Treatments include alarms (activated by... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Enuresis (bedwetting) affects up to 20% of five-year-olds and can have considerable social, emotional and psychological effects. Treatments include alarms (activated by urination), behavioural interventions and drugs.
OBJECTIVES
To assess the effects of enuresis alarms for treating enuresis in children.
SEARCH METHODS
We searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP, and handsearching of journals and conference proceedings (searched 25 June 2018), and reference lists of relevant articles.
SELECTION CRITERIA
We included randomised or quasi-randomised trials of enuresis alarms or alarms combined with another intervention for treating nocturnal enuresis in children between 5 and 16 years old.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed risk of bias and extracted data.
MAIN RESULTS
We included 74 trials (5983 children). At treatment completion, alarms may reduce the number of wet nights a week compared to control or no treatment (mean difference (MD) -2.68, 95% confidence interval (CI) -4.59 to -0.78; 4 trials, 127 children; low-quality evidence). Low-quality evidence suggests more children may achieve complete response (14 consecutive dry nights) with alarms compared to control or no treatment (RR 7.23, 95% CI 1.40 to 37.33; 18 trials, 827 children) and that more children may remain dry post-treatment (RR 9.67, 95% CI 4.74 to 19.76; 10 trials, 366 children; low-quality evidence). At treatment completion, we are uncertain whether there is any difference between alarms and placebo drugs in the number of wet nights a week (MD -0.96, 95% CI -2.32 to 0.41; 1 trial, 47 children; very low-quality evidence). Alarms may result in more children achieving complete response than with placebo drugs (RR 1.59, 95% CI 1.16 to 2.17; 2 trials, 181 children; low-quality evidence). No trials comparing alarms to placebo reported the number of children remaining dry post-treatment. Compared with control alarms, code-word alarms probably slightly increase the number of children achieving complete response at treatment completion (RR 1.11, 95% CI 0.97 to 1.27; 1 trial, 353 children; moderate-quality evidence) but there is probably little to no difference in the number of children remaining dry post-treatment (RR 0.91, 95% CI 0.79 to 1.05; moderate-quality evidence). Very low-quality evidence means we are uncertain if there are any differences in effectiveness between the other different types of alarm. At treatment completion, alarms may reduce the number of wet nights a week compared with behavioural interventions (waking, bladder training, dry-bed training, and star chart plus rewards) (MD -0.81, 95% CI -2.01 to 0.38; low-quality evidence) and may increase the number of children achieving complete response (RR 1.77, 95% CI 0.98 to 3.19; low-quality evidence) and may slightly increase the number of children remaining dry post-treatment (RR 1.39, 95% CI 0.81 to 2.41; low-quality evidence). The evidence relating to alarms compared with desmopressin in the number of wet nights a week (MD -0.64, 95% CI -1.77 to 0.49; 4 trials, 285 children) and the number of children achieving complete response at treatment completion (RR 1.12, 95% CI 0.93 to 1.36; 12 trials, 1168 children) is low-quality, spanning possible harms and possible benefits. Alarms probably slightly increase the number of children remaining dry post-treatment compared with desmopressin (RR 1.30, 95% CI 0.92 to 1.84; 5 trials, 565 children; moderate-quality evidence). At treatment completion, we are uncertain if there is any difference between alarms and tricyclics in the number of wet nights a week, the number of children achieving complete response or the number of children remaining dry post-treatment, because the quality of evidence is very low. Due to very low-quality evidence we are uncertain about any differences in effectiveness between alarms and cognitive behavioural therapy, psychotherapy, hypnotherapy and restricted diet. Alarm plus desmopressin may reduce the number of wet nights a week compared with desmopressin monotherapy (MD -0.88, 95% CI -0.38 to -1.38; 2 trials, 156 children; low-quality evidence). Alarm plus desmopressin may increase the number of children achieving complete response (RR 1.32, 95% CI 1.08 to 1.62; 5 trials, 359 children; low-quality evidence) and the number of children remaining dry post-treatment (RR 2.33, 95% CI 1.26 to 4.29; 2 trials, 161 children; low-quality evidence) compared with desmopressin alone. Alarm plus dry-bed training may increase the number of children achieving a complete response compared to dry-bed training alone (RR 3.79, 95% CI 1.85 to 7.77; 1 trial, 80 children; low-quality evidence). It is unclear if there is any difference in the number of children remaining dry post-treatment because of the wide confidence interval (RR 0.56, 95% CI 0.15 to 2.12; low-quality evidence). Due to very low-quality evidence, we are uncertain about any differences in effectiveness between alarm plus bladder training versus bladder training alone. Of the 74 included trials, 17 reported one or more adverse events, nine reported no adverse events and 48 did not mention adverse events. Adverse events attributed to alarms included failure to wake the child, ringing without urination, waking others, causing discomfort, frightening the child and being too difficult to use. Adverse events of comparator interventions included nose bleeds, headaches and abdominal pain. There is probably a slight increase in adverse events between code-word alarm and standard alarm (RR 1.34, 95% CI 0.75 to 2.38; moderate-quality evidence), although we are uncertain because of the wide confidence interval. Alarms probably reduce the number of children experiencing adverse events compared with desmopressin (RR 0.38, 95% CI 0.20 to 0.71; 5 trials, 565 children; moderate-quality evidence). Very low-quality evidence means we cannot be certain whether the adverse event rate for alarms is lower than for other treatments.
AUTHORS' CONCLUSIONS
Alarm therapy may be more effective than no treatment in reducing enuresis in children. We are uncertain if alarm therapy is more effective than desmopressin but there is probably a lower risk of adverse events with alarms than with desmopressin. Despite the large number of trials included in this review, further adequately-powered trials with robust randomisation are still needed to determine the full effect of alarm therapy.
Topics: Absorbent Pads; Case-Control Studies; Child; Child, Preschool; Clinical Alarms; Combined Modality Therapy; Deamino Arginine Vasopressin; Humans; Nephrology; Nocturnal Enuresis; Placebos; Randomized Controlled Trials as Topic; Renal Agents; Treatment Outcome
PubMed: 32364251
DOI: 10.1002/14651858.CD002911.pub3 -
Pediatrics Jun 2022Children requiring long-term mechanical ventilation are at high risk of mortality. Setting ventilator alarms may improve safety, but best practices for setting...
BACKGROUND AND OBJECTIVES
Children requiring long-term mechanical ventilation are at high risk of mortality. Setting ventilator alarms may improve safety, but best practices for setting ventilator alarms have not been established. Our objective was to increase the mean proportion of critical ventilator alarms set for those children requiring chronic mechanical ventilation followed in our pulmonary clinic from 63% to >90%.
METHODS
Using the Institute for Healthcare Improvement Model for Improvement, we developed, tested, and implemented a series of interventions using Plan-Do-Study-Act cycles. We followed our progress using statistical process control methods. Our primary interventions were: (1) standardization of the clinic workflow, (2) development of an algorithm to guide physicians in selecting and setting ventilator alarms, (3) updating that algorithm based on review of failures and inpatient testing, and (4) enhancing staff engagement to change the culture surrounding ventilator alarms.
RESULTS
We collected baseline data from May 1 to July 13, 2017 on 130 consecutive patients seen in the pulmonary medicine clinic. We found that 63% of critical ventilator alarms were set. Observation of the process, standardization of workflow, and adaptation of an alarm algorithm led to an increase to 85.7% of critical alarms set. Through revising our algorithm to include an apnea alarm, and maximizing provider engagement, more than 95% of critical ventilator alarms were set, exceeding our goal. We sustained this improvement through January 2021.
CONCLUSIONS
Our stepwise approach, including process standardization, staff engagement, and integration of an alarm algorithm, improved the use of ventilator alarms in chronically ventilated pediatric patients.
Topics: Algorithms; Child; Equipment Failure; Humans; Reference Standards; Respiration, Artificial; Ventilators, Mechanical
PubMed: 35641471
DOI: 10.1542/peds.2021-051968 -
HardwareX Oct 2022Intravenous (IV) infusion is a common medical procedure which involves the administration of fluids directly into the blood stream typically through a vein in the arm of...
Intravenous (IV) infusion is a common medical procedure which involves the administration of fluids directly into the blood stream typically through a vein in the arm of the patient. Though gravity fed IV-drip is a safe, effective and an affordable tool, yet several complications can arise in its usage and thus requires constant monitoring. In this paper, a solution is presented for infusion monitoring based on detection of drops falling through the drip chamber. The system presented here accurately tracks the fluid flow and assists the users in monitoring the infusion sessions. The system generates alarm upon detecting significant deviation from set drip rate. The system keeps track of total volume infused and alerts when a desired volume is about to be administered. The device offers a solution to reduce the risks associated with the IV infusion therapy especially in low-resource setting and provide peace of mind to caregivers.
PubMed: 36039318
DOI: 10.1016/j.ohx.2022.e00345 -
Applied Ergonomics Feb 2022When more than one audible alarm is heard simultaneously, discrimination may be compromised. This experiment compares near-simultaneous clinical alarms in two styles,...
When more than one audible alarm is heard simultaneously, discrimination may be compromised. This experiment compares near-simultaneous clinical alarms in two styles, the first are the tonal 'melodies' from the 2012/2006 version of a global medical device safety standard (IEC 60601-1-8) and the second are the auditory-icon-style recommended in the 2020 version of the same standard. Sixty-six participants were required to identify the meaning and priority of four different clinical alarms for one of the two styles of alarm (between-subjects). Alarms sounded both singly and in pairs (within-subjects). Results showed that the auditory icon alarms outperformed the tonal alarms on all measures except one, both for overall accuracy (recognizing both priority and function) and for partial accuracy (recognizing priority or function but not both). The results add to the growing body of evidence supporting the use of auditory icon alarms in clinical environments.
Topics: Clinical Alarms; Humans; Monitoring, Physiologic; Sound
PubMed: 34700191
DOI: 10.1016/j.apergo.2021.103609 -
BMJ Open Quality 2018To provide an overview of documented studies and initiatives that demonstrate efforts to manage and improve alarm systems for quality in healthcare by human,...
OBJECTIVE
To provide an overview of documented studies and initiatives that demonstrate efforts to manage and improve alarm systems for quality in healthcare by human, organisational and technical factors.
METHODS
A literature review, a grey literature review, interviews and a review of alarm-related standards (IEC 60601-1-8, IEC 62366-1:2015 and ANSI/Advancement of Medical Instrumentation HE 75:2009/2013) were conducted. Qualitative analysis was conducted to identify common themes of improvement elements in the literature and grey literature reviews, interviews and the review of alarm-related standards.
RESULTS
21 articles and 7 publications on alarm quality improvement work were included in the literature and grey literature reviews, in which 10 themes of improvement elements were identified. The 10 themes were categorised into human factors (alarm training and education, multidisciplinary teamwork, alarm safety culture), organisational factors (alarm protocols and standard procedures, alarm assessment and evaluation, alarm inventory and prioritisation, and sharing and learning) and technical factors (machine learning, alarm configuration and alarm design). 26 clinicians were interviewed. 9 of the 10 themes were identified from the interview responses. The review of the standards identified 3 of the 10 themes. The study findings are also presented in a step-by-step guide to optimise implementation of the improvement elements for healthcare organisations.
CONCLUSIONS
Improving alarm safety can be achieved by incorporating human, organisational and technical factors in an integrated approach. There is still a gap between alarm-related standards and how the standards are translated into practice, especially in a clinical environment that uses multiple alarming medical devices from different manufacturers. Standardisation across devices and manufacturers and the use of machine learning in improving alarm safety should be discussed in future collaboration between alarm manufacturers, end users and regulators.
PubMed: 30094341
DOI: 10.1136/bmjoq-2017-000202