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Seizures occur more frequently during the neonatal period than at any other period in the lifespan, in part related to the hyperexcitability of the immature neonatal brain.1,2 The prevalence of infants with neonatal onset seizures is approximately 1 to 5 per 1,000 live births.2 Neonatal seizures can be challenging to diagnose clinically because they may be brief or may mimic normal movements and behaviors of healthy infants.3 Continuous electroencephalogram (cEEG) monitoring is the criterion standard for surveillance and evaluation of treatment for neonatal electrographic seizures.4 In a recent multicenter study of 214 infants at risk for or with suspected seizures enrolled from six European neonatal ICUs (NICUs), Rennie et al5 found that neonatal seizures are hard to recognize and difficult to treat. Many of these infants required prolonged cEEG monitoring, sometimes extending for several days.
Hospital-acquired pressure injury (HAPI) is one potential serious adverse effect from the use of EEG electrodes.6 Prevention of pressure injuries (PIs) is gaining focus due to an estimated 2.5 million individuals experiencing a PI each year.7 These types of injuries place patients at risk for infection, pain, advanced wound treatment needs, and prolonged lengths of stay. In addition, an estimated 60,000 patients die of complications of PIs in the US yearly.8 Further, PIs burden the healthcare system with an approximated cost exceeding $26.8 billion in the US annually.7 In the pediatric population, PI occurrence adds an additional $43,180 in hospital costs and an average increase in length of stay of 18 days.9,10 Miller et al10 estimated a 3.5-fold increased risk of in-hospital mortality for pediatric patients with PIs.
Despite the risk of these complications, EEG is critical for evaluation and quantification of seizure burden and treatment responses.11 The instrumentation used in EEG is highly reliant on a clean and secure attachment of the EEG electrodes to the scalp.12 This preparation requires abrasion of the skin to remove the surface epidermal layer. The primary concern with this necessary practice is that preparation and application of the EEG electrodes can lead to skin injury and subsequent infection. The type of electrode used may affect the integrity of skin as well. Electrode cups may cause skin injury related to the pressure from the cup, especially when used for more than a few hours, with the preterm population at highest risk.13
The majority, if not all, of EEG electrode-related pressure injuries (EERPIs) are preventable harm events. Various frameworks have been used to systematically improve care, reduce variation, and prevent EERPIs in neonates. Mietzsch et al14 showed a reduction in neonatal EERPIs from 8.5% (n = 9) in 2013 to 3.5% (n = 7) between March 2014 and August 2015 using quality improvement (QI) methodology.
The objective of this study was to lengthen the number of days between EERPI events in the NICU at the authors’ hospital. The authors aimed for 100 EERPI-free days by 6 months of intervention with the goal to maintain 200 EERPI-free days thereafter (one or fewer EERPI event/year). The ultimate goal of the study was to reach and maintain zero harm events. Process measures consisted of the judicious utilization of EEG days. Balancing measures were the occurrence of EEG electrode-related skin erythema, open wounds, and skin infection.
METHODS Study DesignThe NEOnatal EEG Electrode-Related Pressure Injury Prevention (NEO EERPIP) QI study used the model for improvement and PDSA (Plan-Do-Study-Act) cycles to formally test, analyze, and drive improved practice performance, and used SQUIRE (Standards for Quality Reporting Excellence) 2.0 standards for reporting.15 The study included three study epochs as follows: epoch 1 (January 1, 2019 to June 30, 2019) represented the baseline period, epoch 2 (July 1, 2019 to December 31, 2019) represented the implementation period, and epoch 3 (January 1, 2020 to December 31, 2020) represented the sustainment period. Epochs 2 and 3 comprised the overall QI intervention period.
Context, Setting, and ParticipantsThe study was conducted in a 60-bed level IV NICU with a well-established neurocritical care program, which provides expert care, targeted surveillance, and evidence-based treatment options and support for newborns with serious neurologic problems.
All infants admitted to the NICU between January 1, 2019 and December 31, 2020 who were placed on cEEG for risk of or suspected seizures were included in the study, regardless of gestational age. There were no exclusion criteria. The NICU is exclusively a referral center with all admitted infants outborn.
Study of the InterventionAn interprofessional QI workgroup with representatives from neonatology, pediatric neurology, and neurophysiology (two EEG technicians, one of whom had an administrative role; one outcome specialist nurse; one nurse unit manager; the neonatal neurocritical care coordinator; one pediatric neurologist; and one neonatologist with an administrative role) convened and completed an evidence-based literature analysis for best practices, developed preventive measures, prioritized changes, and carried out improvement efforts. The QI workgroup conducted in-depth event-cause analysis for all stages of EERPI within 48 hours of occurrence to determine underlying contributors and opportunities for improvement.
ProceduresThe QI workgroup developed a fishbone diagram for an easy visualization of potential categories of EERPI risk factors (Figure 1). These elements were analyzed by the QI workgroup to identify those amenable to change with the potential to improve the targeted outcomes.
Figure 1: FISHBONE DIAGRAM IDENTIFYING POSSIBLE CONTRIBUTORS TO NEONATAL EEG-ELECTRODE RELATED PRESSURE INJURY EVENTSAbbreviations: EEG, electroencephalogram; EHR, electronic health record; PI, pressure injury.
Skin AssessmentInconsistent skin assessment at the time of EEG electrode placement was identified as an important opportunity for improvement. In addition, the nursing team and EEG technologists lacked consistent collaboration and communication for ongoing skin monitoring. The authors developed a daily bedside skin assessment tool to standardize the process and help ensure that assessment occurred at the appropriate intervals (Figure 2). The interprofessional QI team recommended daily skin assessment by the direct care nurse collaboratively with the EEG technologist. Scope of roles was closely evaluated by a hospital-wide focus group and nurses were responsible for skin assessment, which is within the nursing scope of practice. The EEG technologist was necessary for performing the technical elements of the assessment, such as identifying electrode locations, removing and replacing electrodes, and performing any troubleshooting tasks that were required. The daily skin assessment included the removal of at least one electrode on each side of the scalp and thorough assessment under and around the device. High-risk electrodes were also assessed, such as those that the neonate was consistently positioned on, including those on the occiput and temporal areas. Scalp skin assessment was also performed by the direct care nurse anytime there was a clinical concern of new skin breakdown. The bedside form was also a useful tool to educate nursing staff on appropriate EEG electrode placement to improve the accuracy of electronic health record (EHR) documentation by including a modified EEG headstamp to demonstrate the neonatal hook-up.16
Figure 2: EEG ELECTRODE-RELATED SKIN ASSESSMENT BEDSIDE TOOLA, Daily skin assessment chart. B, Head stamp figure detailing the position of each EEG electrode on the infant’s scalp, information on what would be considered “high risk” for PI electrodes, recommended patient repositioning frequency, and skin assessment frequency by the EEG technician and direct care nurse.Abbreviations: EEG, electroencephalogram; EHR, electronic health record; PI, pressure injury.
Evaluation of the risk-to-benefit ratio related to continuing the cEEG monitoring versus giving a 24- to 48-hour cEEG monitoring break was performed routinely at day 5 and daily thereafter if cEEG continued. A thorough scalp skin examination was performed on all infants still monitored with cEEG at those time points. This new recommendation was indicated on the skin assessment tool by identifying the timeframe in orange-colored columns to remind staff that this time period was a high risk for skin injury and to prompt this communication within the care team (Figure 2A).
Equipment and MaterialsThe Neurofax EEG-1200 (Nihon Koden) is the standard portable recording system used within the study center. Although the EEG machine itself does not pose a skin injury risk to the patient, the EEG electrodes, being the intermediary device, adhere to the patient’s scalp and can lead to PI.17 The EEG electrode standard in the NICU during epochs 1 and 2 was gold cup disposable electrodes (Table 1). Despite improvements seen with a rigorous scalp skin assessment, the gold cup disposable electrodes continued to pose a PI risk factor given the shape of the cup with consistent pressure application to the skin under the electrode. A logical next step intervention was the evaluation of alternative and more novel EEG electrode options to mitigate this concern. Ultimately, the QI team decided on the use of a flexible hydrogel neonatal electrode type, which consists of a hydrocolloid and gel membrane (Table 1). The flexible hydrogel neonatal electrode was piloted in November and December 2019 (end of epoch 2) and used as standard in epoch 3. Throughout the study, electrodes were prepared and applied using techniques endorsed by a nationally recognized position statement published by ASET—The Neurodiagnostic Society in 2017.18
Table 1 - COST AND APPLICATION DETAILS OF THE ELECTROENCEPHALOGRAM ELECTRODE TYPES USED Characteristic Gold Cup Disposable Electrode Hydrogel Neonatal Electrode Study period January 2019 to November 2019 November 2019 to present Electrode brand Gold Select Disposable Gold Cup Electrode Medline MedGel Neonatal Electrode Cost per package $9.00 (10 electrodes per package) $2.14 (3 electrodes per package) Cost per hook-up $18.00 $10.70 Application procedure (slight variation) 1. Clean surface area.Many interventions were implemented throughout the study using a PDSA approach (Table 2). These interventions included the process updates detailed above, in addition to responsive quick-cycle education sessions to meet the needs of the staff and the phase of the project.
Table 2 - PDSAs and STUDY TIMELINE Date Intervention Feb 2019 Created interprofessional QI team Mar 2019 - Reviewed standard work for daily pre- and post-EEG assessments of EEG electrodes and established collaborative assessment for eachAbbreviations: EEG, electroencephalogram; NEO EEPIP, NEOnatal EEG Electrode-Related Pressure Injury Prevention; NICU, neonatal ICU; PDSA, Plan, Study, Do, Act; QI, quality improvement.
Beyond monitoring for the development of PI, the study team also monitored all incidence of skin breakdown related to the use of EEG electrodes. Authors defined EERPI as localized damage to the skin and underlying soft tissues caused by prolonged pressure from EEG electrodes on the skin. Staging was performed following nationally accepted definitions.19 An open wound was defined as any injury of the skin in which at least the top layer of skin had been disrupted (but was not a PI) including medical adhesive-related skin injuries, skin tears, skin abrasions, or blisters. Skin erythema was defined as intact skin with blanchable redness.
Data AnalysisData on gestational age, birth weight, sex, EEG duration, and repeated EEG application were collected. The EEG skin assessment data were captured on the bedside assessment tool, documented in the EHR, and also stored in the Research Electronic Data Capture. Authors used the Microsoft Excel descriptive statistics and regression analysis package and QI Macros Tool to analyze the data. A P < .05 was considered statistically significant.
Ethical ConsiderationsThis was a research-exempt QI initiative approved by the hospital’s institutional review board.
RESULTS Patient Characteristics and OutcomesSeventy-six infants were placed on cEEG during epoch 1, 80 during epoch 2, and 139 during epoch 3. There were no significant statistical differences among study epochs with regard to infant gestational age, birth weight, sex, or race (Table 3). There was a trend toward higher proportions of preterm infants (gestational age < 37 weeks) during the intervention period (epochs 2 and 3), although this did not reach statistical significance (P = .06). Further, there was no significant difference with respect to the proportion of extremely premature infants (gestational age < 28 weeks) across study epochs (P = .40).
Table 3 - STUDY PATIENT CHARACTERISTICS Characteristic Epoch 1, n = 76 Epoch 2, n = 80 Epoch 3, n = 139 P GA, median [IQR], wk 38 [34, 39] 37 [32, 39] 37 [34, 39] .26 Infants with GA <37 wk, n (%) 23 (30.3) 32 (40) 59 (42) .06 Infants with GA <28 wk, n (%) 7 (9.2) 15 (18.8) 21 (15.1) .40 Birth weight, median [IQR], kg 2.93 [1.99, 3.52] 2.78 [1.53, 3.44] 2.95 [1.97, 3.45] .51 Male sex, n (%) 39 (51.3) 41 (51.3) 73 (52.5) .95 Race, n (%) .86 Black 13 (17.1) 18 (22.5) 26 (18.7) Hispanic 5 (6.6) 6 (7.5) 3 (2.2) Asian 6 (7.9) 0 2 (1.0) White 52 (68.4) 53 (66.3) 99 (71.2) Native Indian 0 0 0 Pacific Islander 0 0 0 Unreported 0 3 (3.8) 9 (6.5) Length of stay, median [IQR], d 15 [8, 39] 22 [7, 71] 17.5 [7, 43] .74Abbreviations: GA, gestational age; IQR, interquartile range.
Authors identified five EERPIs in epoch 1. Of these, three were stage 2 (one located in the posterior scalp and two on the forehead), and two were deep-tissue injuries (both located in the temporal scalp area; Figure 3). Two EERPIs were identified in epoch 2, both of which were unstageable (one located in the occipital area and one in the lateral temporal area). No EERPIs occurred in epoch 3. The number of EERPI-free days increased from an average of 34 days in epoch 1 to 182 days in epoch 2 and 365 days in epoch 3. At the end of the study period, an outcome of 450 EERPI-free days was demonstrated (Figure 3).
Figure 3: G CHART ILLUSTRATING EERPI-FREE DAYSA substantial increase in days between PI events was seen immediately after the roll-out of the bedside EEG skin assessment with further improvement after the use of hydrogel EEG electrodes.Abbreviations: EEG, electroencephalogram; EERPI, EEG electrode-related pressure injury; EHR, electronic health record; PI, pressure injury; QI, quality improvement.
Process MeasuresMedian age at first cEEG hook-up and cEEG-days utilization per study epoch are detailed in Table 4. Average EEG utilization days per patient did not differ by study epoch. A small proportion of infants in each epoch required EEG monitoring more than once (Table 4).
Table 4 - MEDIAN AGE AT FIRST cEEG HOOK-UP AND MEDIAN AND TOTAL NUMBER OF DAYS OF cEEG BY STUDY EPOCH Variable Epoch 1, n = 76 Epoch 2, n = 80 Epoch 3, n = 139 P Total EEG daysa 214 193 338 .13 Median age at first EEG hookup, EEG1, [Q1, Q3], d 3 [2, 6] 4 [2, 20] 3 [2, 12] .38 Median duration of EEG1 monitoring course [Q1, Q3], d 1 [1, 4] 1 [1, 2] 1 [1, 3] .82 Total EEG1 days 178 162 291 .32 No. of infants needing second EEG monitoring course, EEG2, n (%) 15 (19.7) 13 (16.3) 22 (15.8) .87 Median duration of EEG2 [Q1, Q3], d 1 [1, 1] 1 [1, 1] 1 [ 1, 1.5] .79 Total EEG2 days 18 21 36 .49 No. of infants needing third EEG monitoring course, EEG3, n (%) 5 (6.6) 4 (5) 6 (4.3) .86 Total EEG3 days 5 5 10 .13 No. of infants needing fourth EEG monitoring course, EEG4, n (%) 3 (3.9) 2 (0.03) 1 (0.7) .07 Total EEG4 days 11 4 1 .32 No. of infants needing fifth EEG monitoring course, EEG5, n (%) 1 (0.01) 1 (0.01) 0 .31 Total EEG5 days 2 1 0 .22Abbreviations: cEEG, continuous electroencephalogram; EEG, electroencephalogram; Q1, quartile 1; Q3, quartile 3.
aTotal EEG days = sum of EEG1 days + EEG2 days + EEG3 days + EEG4 days + EEG5 days.
The rate of EER scalp erythema increased from 17.5% at baseline to 24.5% after study implementation in epoch 2 but improved to 15.8% in epoch 3 (Figure 4A). Although skin erythema events related to EEG electrodes remained an issue that required continuous surveillance and improvement throughout the study, the open scalp wound events were eliminated after March 2020. This reflects the emphasis placed by the interprofessional QI workgroup on education and training (Figure 4B).
Figure 4: X-CHARTS OF THE ELECTROENCEPHALOGRAM ELECTRODE-RELATED (EER) SCALP SKIN ERYTHEMA AND OPEN WOUND PROPORTIONSA, EER scalp skin erythema control chart; B, open wound control chart across study epochs.
There were no EER localized skin infections or cases in which EERPI was suspected as the source of systemic infections during the 2-year study period.
DISCUSSIONThe NEO EERPIP QI study is the first to report elimination of EERPI in neonates cared for in a level IV NICU sustained for more than a year. The results show that a close interprofessional collaboration with a long-term strategy of deliberate and measured process changes can yield sustained benefits. During the baseline period (epoch 1), there was lower engagement among nurses performing scalp skin assessment at their discretion, which proved to have limited preventive benefit on EERPIs. Introduction of the bedside EEG skin assessment tool and the development of a new interdisciplinary collaboration framework led to a significant decrease in EERPIs in epoch 2. The transition to a new hydrogel EEG electrode type at the end of epoch 2 led to further improvements, with no PI events seen in epoch 3 despite similar average EEG monitoring duration between study epochs. These results are similar to other published studies that targeted EERPI prevention as their main outcome.20 However, because most of the published data targeted adult populations, with only a handful of studies including neonates, this study furthers the QI methodology work for EERPI in this high-risk, understudied population.21,22
Risk factors for HAPI development include exposure to various diagnostic and therapeutic medical devices, inactivity or immobility, friction and shear, hypoxia and poor skin perfusion, fluid retention, and nutrition deficiencies; critically ill neonates may be exposed to all of these factors.23,24 Visscher and Taylor25 found a 6.4% rate of medical device-related PIs in neonates. Compared with term infants, preterm neonates are at an even higher risk for HAPI because of the immaturity of their skin.26,27 Mietzsch et al14 showed that EERPIs are significantly more common in preterm than term infants (13.3% vs 4.9%). The process of skin preparation for EEG electrode application is essential because it decreases artifact signal interference; however, it disrupts the skin barrier by abrading and cleansing the skin. Multiple applications or extended use of EEG electrodes in accordance with the other predisposing factors increase the likelihood of EERPI in the absence of consistent tracking and monitoring using a skin assessment tool. All of these factors need to be taken into consideration during cEEG monitoring.
Commonly used EEG electrode products in the neonatal population include versions of silver-silver chloride electrodes and gold cup electrodes.27 In epoch 2, the researchers introduced a more novel type of EEG electrode made of a breathable polyethylene cloth tape, formulated gel cushion, and adhesive encapsulating the silver-silver chloride electrode and wire housing connection. Although these hydrogel electrodes were previously identified in the literature, this study was the first to evaluate them as tools for neonatal EERPIP.13,28,29
An additional consideration was the cost of the EEG electrodes used during the study (Table 1). The cost difference between gold-cup disposable electrodes and hydrogel electrodes was not significant in comparison with the cost avoidance demonstrated in this project and did not play a factor in the study implementations. With estimates of pediatric HAPI costs at $43,180 per patient, the cost avoidance demonstrated in this project was roughly $172,720 with the implementation of new assessment and monitoring processes and different electrodes (comparing outcomes from baseline [epoch 1] with the intervention period of the study [epochs 2 and 3]).10 In addition, the cost savings from the use of the new hydrogel electrodes compared with the previously used disposable gold cup electrodes is approximately $400 annually.
Strengths, Limitations, and Implications for PracticeDespite a trend toward a higher proportion of preterm infants monitored with cEEG during the intervention period (epochs 2 and 3), the proportion of EERPIs during the same period was significantly lower compared with baseline (epoch 1), reflecting the degree of successful interventions even in this higher-risk population. Without reliable and quality skin assessments, early skin concerns such as erythema go unrecognized and are more likely to develop into PIs. Collaboration between the neonatology and neurophysiology departments to establish standard workflows and define scope for the nurse and EEG technologist roles was essential to this work. Another strength of the study was the continuously monitored quality of the cEEG recordings by fellowship-trained epileptologists because quality control is especially important when introducing new EEG electrodes into the environment.
There are also several limitations to these findings. First, this was a single-center QI initiative with interventions that may not be generalizable if similar resources are unavailable. However, NICU centers providing cEEG monitoring should implement rigorous EEG skin assessment practices, preferably including interprofessional collaboration, because these yielded the best results. Second, it was difficult to quantify the effect size of each key intervention or the additive effect of multiple interventions on EERPI. Nevertheless, this would benefit from further exploration in future studies; the impact of adding more interventions during a QI study could affect the relative benefit. Third, the researchers did not study the effect of staff experience or turnover, which could affect nursing knowledge related to skin assessment in general or familiarity with the unit EEG skin assessment tool.30 Within the scope and resources of this project, it was not possible to explore this line of inquiry. Nevertheless, this could be an important factor for EERPI. Finally, the authors recognized that the bedside EEG skin assessment paper document caused documentation duplication for nursing and EEG technologists; the QI team, in collaboration with clinical informatics, has since developed an electronic documentation flowsheet in the EHR that allows for the more descriptive skin assessment and improves tracking and reporting, altogether improving the workflow for both nurses and EEG technologists.
CONCLUSIONSThe findings of the NEO EERPIP study support the use of multifaceted interventions to prevent EERPIs in neonates and contribute to the literature for this high-risk, underrepresented population. The use of a rigorous skin assessment tool and careful electrode selection combined with a structured framework for interprofessional collaboration between nurses and EEG technologists was critical for the achievement and sustainment of zero EERPIs. These results highlight the need for additional high-quality research and QI studies focusing on reducing medical device-related PI.
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