Pre-eclampsia and eclampsia are leading obstetric causes of direct maternal deaths.1 The incidence of pre-eclampsia is 3.3% of all singleton pregnancies, and the incidence of eclampsia in women with pre-eclampsia is 2.6%.2 Pre-eclampsia and eclampsia can have significant and catastrophic effects on maternal and neonatal morbidity and mortality.1 Diagnosis followed by prompt and effective treatment in the form of appropriate drug administration is crucial to avert significant complications such as cerebral hemorrhage, seizures, hepatic rupture, and placental abruption. In 2011, the American College of Obstetricians and Gynecologists (ACOG) published guidelines that provide explicit details of treatment options in acute severe pre-eclampsia.3 However, healthcare provider’s awareness and actual implementation of these guidelines are not known.
Checklists have been used for several years in various industries, most notably in the aviation and space industry. More recently, they have been introduced into the healthcare profession, with variable implementation in different medical specialties. Several studies have demonstrated that cognitive aids, algorithms, and checklists can improve safety and management in crises.4–7 The ACOG guideline for the treatment of acute severe pre-eclampsia is a text document that cannot be easily used as a quick reference source during an emergency. The same information displayed on a cognitive aid readily available at the bedside may facilitate more timely administration of medications and reduce missed critical steps in the emergency management of severe pre-eclampsia and eclampsia.
The aims of the study were to assess healthcare provider application of knowledge during the management of severe pre-eclampsia and eclampsia in a tertiary referral center and to determine whether utilization of a cognitive aid could positively impact treatment interventions and timing of treatment. The primary outcome measure was administration of the correct first-line antihypertensive drug (per ACOG guidelines) if systolic blood pressure was 160 mm Hg or greater and/or diastolic blood pressure was 110 mm Hg or greater. Secondary outcome measures included the following: administration of magnesium sulfate, percentage and timing of groups that completed all the critical tasks, key anesthesia tasks performed, if the cognitive aid was utilized, and if its use improved management.
The simulation study was performed on labor and delivery at Lucile Packard Children’s Hospital at Stanford, California, during a 5-month period in 2012. Thirteen multidisciplinary teams consisting of 7 to 9 participants including obstetricians, anesthesiologists, and nurses participated in this Stanford University Institutional Review Board–exempt study. The experience level of each team was not controlled. Each team encountered the same simulation scenario that involved a pre-eclamptic parturient who progressed to eclampsia with a recurrent nonterminating seizure, followed by a cesarean delivery due to prolonged fetal bradycardia. The participants were unaware of the scenario topic before the drill. The drill had not been performed before the study. All participants signed a confidentiality agreement before the drill.
Before starting the scenarios, participating teams were randomized into 2 groups. One group was randomized to have a cognitive aid available to use throughout the drill (group A), and the other group would not have a cognitive aid available to use at any point throughout the drill (group B). Group allocation was done using computer-generated random number allocation using Microsoft Excel 2010 (Seattle, Wash). The teams were not aware that they were randomized nor that their performance was being studied. Group A participants (only) were verbally made aware of the cognitive aid at the briefing immediately before the drill. The cognitive aid was not visualized before the drill, nor did participants receive an explanation how to effectively use a cognitive aid. The use of the cognitive aid was not enforced and the choice to use/not use the cognitive aid was left to the participants. Researchers stated that “A cognitive aid will be available at the point-of-care and can be used by any team member and will be available during the postscenario debrief for reference.” The cognitive aid (Figs. 1A, B) consisted of a double-sided letter-sized colored laminated sheet, with an algorithm on either side. The algorithms were “treatment of severe pre-eclampsia” and “management of eclampsia.” The cognitive aid and treatment protocols were adapted from the ACOG guidelines3 published in 2011, by a board-certified maternal-fetal medicine specialist and a fellowship-trained obstetric anesthesiologist. The authors chose the ACOG guidelines as the criterion standard. The cognitive aid was placed in a visible location in the labor examination room (upright on the counter top) as well as in the operating room (OR, upright on the anesthesia machine) before the start of the drill. Cognitive aids were not discussed with group B during any part of the drill, including the debrief after the scenario.
The simulation scenario consisted of a standardized patient (actor) who had just been admitted to labor and delivery complaining of not feeling well and nausea. The patient was at 37-week gestation with a singleton pregnancy, gravida 1 para 0 without any previous problems in the pregnancy. The bedside nurse, who was alone at the start of the drill, was triggered to call the obstetric resident to assess the patient in the examination room because of high blood pressure measurements necessitating emergency treatment with intravenous (IV) antihypertensive medication. During the consultation by the obstetric resident, the standardized patient had a generalized seizure, which was self-terminating after less than 30 seconds. Teams then decided whether to stay in the examination room or to move to the OR. Irrespective of whether treatment medication (antihypertensive) or prophylactic medication (magnesium sulfate) was administered to the patient (now a mannequin in the OR), the patient had a second seizure. The second seizure was not self-terminating and was complicated by fetal bradycardia (60 beats per minute) and maternal hypoxemia (oxygen saturations < 92%). Airway protection and oxygenation were at the discretion of the anesthesiologist participating in the drill. Fetal bradycardia persisted and the participating obstetrician had to make the decision either for intrauterine resuscitation or for cesarean delivery.
Key interventions (if performed and time taken to be performed respectively) were recorded throughout the drill for both groups (Table 1).
The primary outcome measure was administration (yes/no) of the correct first-line antihypertensive drug if systolic blood pressure was 160 mm Hg or greater and/or diastolic blood pressure was 110 mm Hg or greater (Table 2). We selected antihypertensive medication as primary outcome because of the emphasis placed on appropriate utilization by ACOG guidelines.
Secondary outcome measures included the following: administration of magnesium sulfate (yes/no) (Table 2); percentage and timing (minutes and seconds) of groups that completed all the critical tasks (Table 1); key anesthesia tasks performed (Table 3); if the cognitive aid was utilized (yes/no); and if its use improved management by comparing the number of tasks completed, as well as the time taken for group A versus group B. Demographic information was also obtained from the participating personnel including number of years of experience for the labor and delivery nursing staff.
We used a convenient sample size on the basis of the number of drills being conducted at our institution for purposes of staff training. Study data are summarized with descriptive statistics, and results are expressed as the mean (SD), median [interquartile range (IQR)], and percentages, as appropriate. We were unable to perform analytical statistical analyses between groups because none of the participating teams used the cognitive aid. Cohort descriptive analyses were performed with IBM SPSS Version 20.0 for Windows statistical package (Armonk, NY).
Thirteen teams with a total of 96 participants participated in the drill and were included for study analysis. All teams completed the drill. The teams consisted of 1 anesthesia resident, 1 to 3 obstetricians (21% attendings, 4% fellows, 75% residents), 4 to 5 labor and delivery nurses, and 1 to 2 technicians. The mean (SD) number of years of nursing experience per team was 14 (5). Seven of 13 groups were randomized to have a cognitive aid available throughout the drill (group A), and 6 were not (group B). Despite participants being made aware during the prebrief that a cognitive aid would be available to use during the drill, none of the 7 teams in group A that were randomized to have a cognitive aid actually used it; so the following data are collapsed across groups.
The key treatment intervention results for the 13 team study cohort are outlined in Tables 2 and 3. The primary outcome measure (administration of the correct first-line antihypertensive medication) was performed by 92% (12/13 teams). One team did not administer any antihypertensive medication. Of the 12 teams that did administer antihypertensive medication, only 58% (7/12) used the correct drug, dose, and route for the first-line antihypertensive medication (labetalol 20 mg IV or hydralazine 5–10 mg IV) as per ACOG guidelines.2 All teams requested and administered a bolus dose of magnesium sulfate (4–6 g IV) after the onset of the first seizure. Only 15% (2/13) of teams took appropriate action to lower the blood pressure to a “safe range” before induction of general anesthesia, and 31% (4/13) anesthesiologists made drug modifications for induction of anesthesia and intubation.
Only 1 of 13 teams completed all the required critical tasks (Table 1), with a time of 13 minutes 27 seconds. Most omissions for other groups were incorrect dose for labetalol, no protective airway maneuvers during the seizure (before the arrival of the anesthesiologist), and no drug modifications for intubation. Fifteen percent (2/13) groups made attempts to protect the patient’s airway during the seizure, before the arrival of the anesthesiologist (Table 3). The airway management maneuver that was chosen involved turning the patient to the lateral position from the supine position; however, no direct mandibular support was applied. Ten groups made attempts to protect the patient’s limbs during the seizure, and 1 group made no attempt to protect the patient at any time during the seizure.
Our results show that antihypertensive medication is not universally administered in compliance with current guidelines. With integration of ACOG guidelines3 into clinical practice specifically targeting the management of severe pre-eclampsia, it was interesting to find that only 58% of the 92% of teams that administered an antihypertensive medication administered the correct drug, dose, and route. This finding is surprising because only 2 first-line drugs need to be remembered. Labetalol and hydralazine have been selected by ACOG as first-line antihypertensive medications for management of hypertension in the setting of severe pre-eclampsia or eclampsia, with the aim of reducing blood pressure to decrease the incidence of central nervous system morbidity and mortality. This study is a demonstration of a simulation drill involving actual current clinical practice. It can occur that evidence-based medicine is not always translated into clinical practice unless there are specific institutional guidelines in force, appropriate equipment and/or trained staff.8
A report published by the California Maternal Quality Care Collaborative in 2013 recommended initiation of antihypertensive therapy within 60 minutes of elevated blood pressure and within 30 minutes after confirmation of severe range blood pressures if possible.9 Clark and Hankins10 suggest that women should receive IV antihypertensive treatment within 15 minutes of the diagnosis of pre-eclampsia with blood pressures of 160/110 mm Hg or higher because many more women will benefit from an initial dose of labetalol or hydralazine than will be harmed by a single dose. A contributing factor of delayed treatment can be drug accessibility, most likely as a result of hospital admission or pharmacy administration issues. To reduce delays in drug availability, we produced and implemented a point-of-care “severe pre-eclampsia and eclampsia box” on our labor and delivery ward. This box consists of drugs that may immediately be required to treat severe pre-eclampsia or eclampsia (Appendix A). The drug contents of this box and treatment algorithms (Figs. 1A, B) have been acquired by the California Maternal Quality Care Collaborative for their report.9
Although all teams requested magnesium sulfate, the requests were made after the seizure as treatment and subsequent prophylaxis, rather than as initial prophylaxis after the diagnosis of severe pre-eclampsia was made (as per ACOG recommendation). There were also long-time delays to administer magnesium sulfate. Future training needs to emphasize prophylactic treatment with magnesium sulfate as early as possible after diagnosis of severe pre-eclampsia. Evidence shows that this practice halves the risk of pre-eclamptic women developing eclampsia.11,12 When magnesium sulfate is administered during an eclamptic seizure, 10% to 15% of women will have a subsequent seizure, as was the case in the drill.13 Most groups used a 4-g magnesium sulfate dose; both 4- and 6-g doses are supported by literature.14,15
There was great variability and often suboptimal attempts to protect the patient’s airway during the seizure. Nursing staff at our institution has attended an obstetric life support course16 and has been taught protective airway maneuvers, so we might anticipate even worse performance at other institutions. From the authors’ observation, during simulation drills, participants report nervousness, apprehension, and inability to suspend disbelief, which can all potentially negatively impact participant’s performance. Participant’s usual “real-world” decision-making processes can be disregarded in the “simulation world,” which can lead to human error.17 We purposely started the drill in a small examination room to see whether teams would transport the patient to a safer environment such as the OR, for example. All teams did move to the OR, which made it easier to intervene with airway management and perform surgery if required.
Laryngoscopy directly increases sympathetic outflow, which can cause a hypertensive response if drug modifications are not instituted to obtund the response. This response is dramatically intensified in pre-eclamptic and eclamptic patients; therefore, efforts need to be made to try to attenuate this response and prevent such complications as cerebral hemorrhage and cardiac failure with pulmonary edema.18 Fifty-four percent (34/63) of deaths from pre-eclampsia and eclampsia from 1999 to 2008 were caused by intracranial hemorrhage.1 It is not known from the literature source if laryngoscopy contributed to the hemorrhages from 2006 to 2008; however, there are cases reported from 2003 to 2005 where there were significant rises in blood pressure postintubation and these women had radiological evidence of intracranial hemorrhage and subsequently died.19 Authors have suggested that the “anesthetist should be given as much time as possible to try to prevent the pressor effects of intubation in the pre-eclamptic woman, even when there are pressing fetal reasons for urgent cesarean section under general anaesthesia.”19
The degree of systolic hypertension (as opposed to the level of diastolic hypertension or relative increase or rate of increase of mean arterial pressure from baseline) is believed to be the most important predictor of cerebral injury and infarction.3 The aim should be to reduce the blood pressure, but not to normalize it, and ACOG recommends 140–160/90–100 mm Hg.3 We appreciate that there is no specific “safe blood pressure range” before intubation for all patients and it is a risk-balance situation with regard to timing and optimization for a safe outcome. However, we included a “safe blood pressure” task endpoint to try and determine whether consideration was given to reducing the blood pressure before intubation. Recommended drugs in addition to an induction agent and a depolarizing muscle relaxant to reduce the intubating response include esmolol 1.5 mg/kg, esmolol 1 mg/kg, lidocaine 1.5 mg/kg, or an opioid such as remifentanil.18,20,21 Whichever drug the anesthesiologist uses, it is important that they are familiar with the drug in terms of onset time and desired effect and are not using it for the first time in an event when precise timing in relation to laryngoscopy is critical. Extubation is also a critical time when drug modification(s) need to be considered to avoid an acute rise in blood pressure.
We could not determine whether a cognitive aid would have a positive impact on the treatment of pre-eclampsia and eclampsia, because none of the teams used the cognitive aid. We did not change the study protocol after initiating it and observing none of the first few teams used the cognitive aid because we had a small total number of teams and wanted group A and group B to run as planned for full analysis. Failure to use the cognitive aid by any of the 7 teams randomized to having it available is an interesting study finding, although this does relinquish information that could have been gained on how the cognitive aid may have actually been used. It highlighted the need to introduce cognitive aids before their utilization in an acute clinical setting. The most common reasons why teams that were randomized to have the cognitive aid available but did not actually use it determined from the debriefs included the following: unfamiliar with using checklists/cognitive aids in routine or emergency practice, unfamiliar with the specific cognitive aid, and forgetting that a cognitive aid was readily accessible to any member of the team during the drill. For the last decade, anesthesiologists in particular have been exposed to cognitive aids for routine as well as emergency situations to help improve patient care and safety. Other disciplines such as obstetrics and labor and delivery nursing have had less exposure, if any, to cognitive aids. Because there was only 1 anesthesiologist in each of the multidisciplinary teams that participated in our drills, they may have found it difficult to implement without becoming task saturated. Goldhaber-Fiebert and Howard6 emphasized “create, familiarize, use, and integrate” to establish successful implementation of cognitive aids. We created the cognitive aid in a flow sheet box style (Figs. 1A, B) with bright colors to aid visual analysis and help clarify understanding. However, despite availability of a simple checklist that is easy to interpret and follow, our study findings suggest that previous familiarization is critical for implementation. We did not familiarize the participants beforehand to the cognitive aid because our aim was to simulate a real-life emergency situation. Participants sometimes get “stage fright” during simulation drills, and no matter what amount or type of information was conveyed to them before the drill started, recall of this information can be negligible during the event.
The relative risk of eclampsia in pre-eclamptic women has risen2; therefore, it is important for specialist management knowledge to be appreciated and disseminated. Labor and delivery units are not always staffed by obstetric anesthesia specialists despite multidisciplinary specialist care being a recommendation in the report from the Centre of Maternal and Child Enquiries.1 Updated knowledge and education are important to try and reduce maternal and neonatal morbidity and mortality.
In conclusion, our results suggest that knowledge of healthcare providers in a tertiary referral center with specialist obstetric care is excellent with regard to magnesium sulfate utilization; however, the use of antihypertensive medication is not universally compliant with current guidelines. The importance of blood pressure management to reduce maternal morbidity and mortality in the setting of pre-eclampsia and eclampsia needs to be emphasized to all healthcare providers of obstetric patients. This information also needs to be highlighted to anesthesiologists with particular emphasis on the physiological changes that can occur with intubation and extubation in this specific patient population. Interestingly, availability of a cognitive aid does not ensure its utilization in an emergency. This study suggests that for cognitive aids to be utilized and effective in clinical care, it is essential that staff is familiar with them before an event. Future studies in this field are required to evaluate whether cognitive aids improve treatment interventions and patient outcomes. Studies are also needed to investigate the most effective way to educate staff to prepare for emergencies and to ensure integration of cognitive aids into education and clinical practice.
The authors would like to acknowledge that before publication of this manuscript, revised ACOG guidelines were published by the Committee on Obstetric Practice (Obstet Gynecol 2015;125:521–525).
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Contents of Labor and Delivery Severe Pre-eclampsia and Eclampsia