When every minute counts

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Medical negligence

May 2011, Volume 47, No. 5

When every minute counts 

Dov Apfel

Planning for obstetrical emergencies is a critical function of every hospital. Clinicians know that ‘emergent’ or ‘stat’ surgical intervention may be required when maternal, placental, or fetal conditions suddenly compromise the delivery of oxygen or blood flow to the fetus. The response must be immediate and include a ‘bundle’ of simultaneous steps.

 

SIDEBAR

Deposition questions for clinicians
by Dov Apfel

Hypothermia therapy and the standard of care
by Allyson Kayton

About 85 percent of the more than 4 million live births in the United States annually (about 3.4 million babies) are assessed during labor with electronic fetal monitoring.1 Prudent, well-educated clinicians know that obstetrical emergencies may develop while they monitor their patients—even patients considered low-risk. Emergency cesarean deliveries are performed in some hospitals at the rate of one per 159 deliveries, or one per 40 cesarean sections.2

The most obvious circumstance that may require emergent or “stat” surgical intervention is when the fetal heart rate (FHR) drops down to 60 beats per minute. Among the complications that can lead to bradycardia, prolonged decelerations, or recurrent late or variable decelerations with minimal or absent FHR variability are placental abruption, excessive vaginal bleeding, uterine rupture, cord prolapse, amniotic fluid embolism, trauma, excessive uterine activity, infection, and severe preeclampsia. A fetus can develop global or regional asphyxial brain damage or die when it is deprived of adequate oxygen (hypoxia) or blood flow (ischemia).3

The 2007 Guidelines for Perinatal Care, published jointly by the American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics (AAP), provide that “all hospitals offering labor and delivery services should be equipped to perform an emergency cesarean delivery.”4 According to these guidelines, the duty to perform an emergency delivery requires that hospitals be able to begin a cesarean delivery within 30 minutes of the decision to operate.5 Questions have been raised in the worldwide medical literature about whether the 30-minute decision-to-incision interval is a standard of care requirement or merely a capability, whether 30 minutes is a reasonable rule or guideline, and whether a shorter time frame is achievable—and perhaps even required—for certain obstetrical emergencies.6

ACOG revisited the decision-to-incision interval in its 2010 clinical management guidelines for interpreting intrapartum FHR tracings.7 The organization recognized that there are abnormal FHR tracings (known as Category III)—which include bradycardia and recurrent late or variable decelerations with absent FHR variability—that convey an increased risk for fetal acidemia at the time of observation.8 According to ACOG, Category III tracings, if unresolved, most often require prompt delivery.

Unfortunately, ACOG missed an ideal opportunity to endorse hospital programs and protocols calling for specialized education and training and appropriate response times for clinicians to begin and complete an emergency or stat delivery for Category III FHR patterns. Instead, ACOG simply recommended that, when a decision for operative delivery in the setting of a Category III FHR tracing is made, it should be accomplished as expeditiously as feasible.9

ACOG prefers a loose, undefined ¬decision-to-incision interval, which will be determined case by case, subject to each hospital’s unique circumstances, logistical issues (such as obtaining informed consent, assembling the surgical team, transporting the patient to the operating room, and assessing the patient’s need for a catheter), and other potential problems that may arise when mothers have or develop high-risk conditions (such as morbid obesity, eclampsia, cardiopulmonary compromise, and hemorrhage).

ACOG also cited a study of 2,808 emergency cesarean deliveries due to umbilical cord prolapse, placental abruption, placenta previa with hemorrhage, nonreassuring FHR patterns, or uterine rupture, for the erroneous proposition that expedited delivery within 30 minutes will not improve neonatal outcomes.10 The authors reported that 65 percent of the deliveries were commenced within 30 minutes of the decision to operate, 27 percent within 20 minutes, and 17 percent within 10 minutes. While the authors observed that 95 percent of the 538 infants delivered more than 30 minutes after the decision to operate did not experience an adverse outcome, ACOG overlooked the following facts: 5 percent of the 538 infants did suffer injuries; 98 percent of the deliveries for cord prolapse, abruption, and uterine rupture met the 30-minute-or-less guideline; and the authors did not discuss the specific nonreassuring FHR patterns that triggered the expedited delivery in the 538 cases that were completed after 30 minutes.11

To rationally determine whether expedited delivery affects neonatal outcomes, one must not look solely at the decision-to-incision interval. The interval from the onset of the bradycardia, fetal distress, or Category III tracings to delivery is far more critical when analyzing the timing and benefit of surgical intervention. When the underlying indication for an obstetrical emergency is acute and there is a risk of severe hypoxia and/or ischemia caused by excessive uterine activity, abruption, cord prolapse, or uterine rupture, decision-to-delivery intervals of less than 30 minutes are necessary to prevent or minimize fetal asphyxial brain injury.12

Response times based on data

Much of our knowledge about the adverse effects of hypoxia, ischemia, and asphyxia is based on animal experiments in which oxygen and/or blood flow to the fetus was disrupted, and the fetal response was studied. Researcher William Windle performed the earliest experiments on rhesus monkeys in 1968.13 He demonstrated that an acute asphyxial episode of less than 8 minutes may not cause brain damage, an episode of more than 8 but less than 10 minutes produced transient neurological signs, and asphyxia lasting more than 12 minutes caused irreversible brain damage and functional deficits.

Ronald Myers showed that 12 to 13 minutes of total asphyxia caused brain damage in primates, and total asphyxia lasting more than 20 minutes often led to the death of the fetus.14 Alan Hill more recently confirmed that major irreversible injury located predominantly in the deep gray matter can occur in primates after 10 to 11 minutes of an acute, total deprivation of oxygen or blood flow.15 Thus, experimental animal data confirms that, in cases involving anoxia or total asphyxia, the interval between the decision to perform an emergency cesarean section and the delivery can have a significant effect on neonatal outcome in humans.16

Many studies of neonatal outcomes in human infants have confirmed that clinicians must select those babies who are at the highest risk of hypoxic or ischemic injury and promptly prepare for delivery, especially in the presence of prolonged decelerations and sustained bradycardia. Clinicians should not delay their preparations for cesarean delivery based on a hope that the prolonged deceleration or bradycardia will eventually recover.

In a study of the maternal and fetal consequences associated with uterine rupture, researchers found that significant neonatal morbidity was encountered when 18 minutes or more elapsed between the onset of a prolonged deceleration and delivery.17 They also observed that fetuses tolerated less than 18 minutes of prolonged decelerations and bradycardia when they were preceded by severe late decelerations.

Another study recommended that, when a pregnant woman experiences cardiac arrest for any reason, obstetricians should attempt to begin an expedited cesarean section within four minutes and deliver the infant within five minutes after the maternal cardiac arrest.18 According to the authors, this time interval will provide the optimal opportunity for saving the lives of both the mother and the child. The authors reviewed the literature concerning fetal outcome in cases of maternal cardiac arrest, as well as Windle’s animal experiments, and concluded that “the evidence is overwhelming that the sooner the infant is delivered after the arrest (preferably within five minutes), the better his or her prognosis.”19

Other investigators concur that the suggested guideline of a 30-minute decision-to-incision interval must be shortened.20 They observed that, in some circumstances (such as complete cord occlusion, complete abruption, massive blood loss, and fixed fetal brady¬cardia), delivery should occur in less than 5 minutes—and no longer than 15 minutes—after the need for immediate intervention is recognized.

The significance of a timely response and delivery in the presence of prolonged decelerations and bradycardia was the focus of a study of 235 cases of singleton neonates delivered by urgent cesarean section.21 The median ¬bradycardia-to-delivery interval was 16 minutes, and the decision-to-delivery interval was 11 minutes. Explaining that all of the neonates were delivered within 19 minutes, the authors stated that “our result demonstrated clearly that a short ¬decision-to-delivery interval is possible in a well-organized unit with experienced staff. We were able to achieve 100 percent delivery within 20 minutes of the decision-to-delivery interval, with a median value of 10 minutes.”22

The authors emphasized that, when the underlying cause is irreversible (such as with abruption, cord prolapse, severe eclampsia, and failed instrumental delivery), the cord pH deteriorates rapidly starting from the onset of the fetal bradycardia, and immediate delivery is essential to minimize the risk of irreversible fetal brain damage due to hypoxia.

Finally, a recent study of 19 cases was performed to evaluate the effect of the interval between the onset of sustained fetal bradycardia below 100 beats per minute and cesarean delivery on long-term neonatal neurological outcome.23 Before the onset of the bradycardia, the FHR was reassuring in all the cases. Emphasizing that a 30-minute ¬decision-to-delivery interval is too long to prevent unfavorable neurological outcomes, the authors recommended that the “decision-to-delivery interval should be less than 20 minutes in order to keep the interval between onset of the bradycardia and cesarean delivery at less than 25 minutes. . . .”24

There is no better place to watch for the recovery of recurrent late or variable decelerations with minimal variability or a bradycardia in the 60s than in the OR, with a rapid response team ready to deliver should the FHR fail to respond to intrauterine resuscitative measures. A “wait and see” or “hope for the best” approach is below the standard of care, as any apparent recovery may be brief and followed by a sustained bradycardia or loss of variability, indicating the baby is probably developing asphyxial brain damage.

Improving response times

There are many reasons why stat cesarean deliveries are not performed as rapidly as possible. The delay may be due to the time it takes a bedside nurse to recognize the emergency and perform interventions, the nurse to contact the attending physician, the attending to review the FHR and decide to order an emergent delivery, the team to assemble, and/or the anesthesiologist to arrive and prepare the patient for surgery.

Yet many hospitals have the capability of starting and completing stat cesarean sections in less than 30 minutes when indicated. One hospital reported a vastly improved decision-to-incision time of 11 minutes, with the implementation of new procedures and the creation of rapid response teams for handling obstetrical emergencies.25 Another hospital reported that close collaboration among the staff consistently achieved a decision-to-delivery interval of less than 20 minutes.26

In view of such evidence, the key to improving response times and delivery intervals for obstetrical emergencies is to adopt an emergent delivery rapid response protocol calling for simultaneous steps performed by a properly trained perinatal team. Hospital protocols should permit nurses to activate the team for any condition that poses a potential or immediate threat to maternal or fetal well-being, such as when Category III tracings or other signs of fetal distress develop. Once a nurse activates a rapid response, all team members (including the attending, the surgical team, the anesthesiologist, and the neonatologist) should be prepared to act simultaneously.

For the rapid response team approach to succeed, hospitals must devote adequate efforts to training. Emergency drills should be conducted to ensure that all team members are prepared to meet any recommended delivery goal—whether 5 minutes, 10 minutes, or 20 minutes.

Training should become a critical component of the standard of care, and hospitals should not be permitted to avoid liability if they fail to properly train, educate, and prepare their staff to recognize when a rapid response and emergency delivery is necessary and how quickly the delivery must be performed to minimize or prevent brain damage or fetal death.

In this regard, hospital risk managers, as well as ACOG and the Association of Women’s Health, Obstetric, and Neonatal Nurses, should heed the warning of a 2009 analysis of the latest National Institute of Child Health and Human Development guidelines for categorizing FHR patterns.27 The authors said the new EFM guidelines will fail to improve outcomes unless they are integrated into a “bundle” of activities or steps that must include four components: credentialed staff, an escalation policy, a known responsible physician, and the capability for an institutional rapid response. The same approach can be adopted to construct an emergency delivery rapid response bundle.

The first criterion of the rapid re¬¬sponse bundle is that all clinicians must be qualified to read, appropriately interpret, and respond to FHR tracings.28 To accomplish this goal, training should be the same for physicians, midwives, and nurses, and documentation of every clinician’s competence should be required. Standards must be developed for recognizing a fetus’s intolerance of labor and for beginning preparations for delivery. The decision to intervene will rarely lead to an improved outcome if it is made too late in a chain of events beginning with hypoxia and/or ischemia and progressing to acidosis and asphyxia.

The bundle’s second requirement is an escalation policy or an algorithm for nurses and residents to use when they conclude that assistance is required or that steps leading to an expedited delivery should be initiated. This criterion requires hospitals to do more than pay lip service to educating nurses about the chain of command; it requires that nurses be taught and encouraged to act as patient advocates, without fear of repercussion, and to communicate effectively with physicians and other nurses.29

Nurses must be trained not only to recognize when expedited delivery is indicated but also how to begin preparations and notify critical personnel, even when the attending physician is not present or before the decision to expedite delivery is made. Too often, critical minutes will be lost while nurses wait for an attending physician to arrive at the bedside to order a cesarean section before they mobilize the team or move the patient to the OR.

The third component of the bundle requires hospitals to insist that attending physicians be immediately available in the hospital to resolve a potential obstetrical emergency.30 This is of critical importance when oxytocin is being used to induce or augment labor.31 Each attending also must have a backup, known to the nursing staff, who is available to respond if the attending physician is not immediately available. The backup physician must be prepared to become available immediately whenever the attending has two or more patients in labor.

The fourth component of the bundle is making sure that the institution can respond rapidly, with all the necessary personnel and resources ready to assist the attending physician with an emergent delivery. Once again, this requires vigilance and the simultaneous notification of critical team members when expedited delivery is anticipated or indicated. Obviously, a surgeon and anesthesiologist must be immediately available, an OR must be available, and the surgical team must be ready to prepare the patient and assist in the OR.

Studies have shown that crash cesarean section drills and standardized procedures can improve fetal outcomes. According to one study, after the introduction of educational training courses in 2000, the number of infants born with 5-minute¬ Apgar scores of 6 or less decreased from 86.6 to 44.6 per 10,000 births, and the number of infants with hypoxic-ischemic encephalopathy decreased from 27.3 to 13.6 per 10,000 births.32 The course included emergency drill training, group case discussions of FHR patterns, lectures, and workbook assignments. Annual attendance was mandatory for all midwifery and medical staff.

The authors emphasized that, during labor, one of the most important skills for clinicians to develop is the ability to recognize fetal compromise in time to deliver before asphyxia and brain damage develop. They stressed that the proper interpretation of FHR tracings and timely intervention will make a difference in fetal outcomes.

Similarly, other researchers have concluded that implementing educational programs and establishing a scripted response—for example, a “code green” protocol—to improve communication and establish clear-cut roles for each team member when emergency cesarean deliveries are needed will improve neonatal outcomes.33

Litigation issues

Attorneys who have experience deposing obstetricians, residents, and nurses know that, unfortunately, clinicians often have no clue as to how quickly a normal, reassuring FHR tracing can turn into an abnormal, pathological, nonreassuring, or ominous Category III tracing. In fact, it is often impossible to get a coherent answer when asking a clinician how many minutes a fetus can tolerate sustained bradycardia, or repetitive late or severe variable decelerations with minimal or absent variability, before damaging asphyxia will begin or cause brain damage. Many deponents respond with a blank stare when asked these questions.

A major change in hospital culture is needed to improve response times and neonatal outcomes. When every minute counts and unnecessary delay may lead to brain damage or death, it is hardly a waste of time for nurses to activate a rapid response team and prepare a patient for emergent delivery. The decision to perform an expedited cesarean delivery and the time within which that delivery should be completed should be based on the indication for the emergency intervention and not on an arbitrary rule, a theoretical capability, or a vague guideline.

By identifying the circumstances for which nurses should activate the emergency delivery rapid response team, further education and training will reduce the number of unnecessary surgical interventions and improve response times, all to the benefit of the babies whose asphyxial brain damage and cerebral palsy can be prevented or minimized with emergent or stat delivery.

Dov Apfel is a partner with Janet, Jenner & Suggs in Baltimore. He may be reached at dapfel@medlawlegal team.com. © 2011, Dov Apfel.

Notes

  1. See Sally C. Curtin & Melissa M. Park, Trends in the Attendant, Place, and Timing of Births, and in the Use of Obstetric Interventions: United States, 1989–97, 47 Natl. Vital Statistics Rpts. 4 fig. 5 (Natl. Ctr. Health Statistics Dec. 2, 1999), www.cdc.gov/nchs/data/nvsr/nvsr47/nvs47_27.pdf.
  2. See David C. Lagrew, Emergent (Crash) Cesarean Delivery: Indications and Outcomes, 194 Am. J. Obstetrics & Gynecology 1638 (2006).
  3. For a scholarly analysis of the adverse effects of hypoxia, asphyxia, and hypoxic-ischemic encephalopathy and their role in causing cerebral palsy and other brain damage, see generally Joseph J. Volpe, Hypoxic-Ischemic Encephalopathy, in Neurology of the Newborn 247 (5th ed., Saunders 2008).
  4. See Am. Acad. Pediatrics (AAP) & Am. College Obstetricians & Gynecologists, Guidelines for Perinatal Care 159 (6th ed., AAP 2008).
  5. Some states, such as Illinois and Louisiana, have created statutory regulations requiring hospitals to have adequate staff to ensure that a cesarean section can be performed within 30 minutes of the decision to operate. See e.g. Ill. Adm. Code tit. 77, pt. 640.41(b)(4) (2011); La. Admin. Code tit. 48, §9509a.2.c. (2010).
  6. For a general overview of the controversy, see Roberta Haynes de Regt et al., Time from Decision to Incision for Cesarean Deliveries at a Community Hospital, 113 Obstetrics & Gynecology 625 (2009); Isabelle Sayegh et al., Evaluating the Decision-to-Delivery Interval in Emergency Caesarean Sections, 116 European J. Obstetrics & Gynecology & Reprod. Biology 28 (2004).
  7. Am. College Obstetricians & Gynecologists, Management of Intrapartum Fetal Heart Rate Tracings, Prac. Bull. No. 116, 116 Obstetrics & Gynecology 1232 (2010).
  8. ACOG endorsed the three-tier classification system for categorizing FHR patterns recommended by the National Institute of Child Health and Human Development. See Dov Apfel, The Case for National Fetal Monitoring Standards, Trial 26 (May 2009), www.justice.org/cps/rde/xchg/justice/hs.xsl/8789.htm.
  9. Am. College Obstetricians & Gynecologists, supra n. 7, at 1237–38.
  10. See e.g. Steven L. Bloom et al., Decision-to-Incision Times and Maternal and Infant Outcomes, 108 Obstetrics & Gynecology 6 (2006).
  11. Id. at 8–10.
  12. See Dov Apfel, Birth Asphyxia and Cerebral Palsy, Trial 52 (Jan. 2007).
  13. William F. Windle, Brain Damage at Birth: Functional and Structural Modifications with Time, 206 JAMA 1967 (1968).
  14. Ronald E. Myers, Four Patterns of Perinatal Brain Damage and Their Conditions of Occurrence in Primates, 10 Advs. Neurology 223, 224–25 (1975).
  15. Alan Hill, Hypoxic-Ischemic Cerebral Injury in the Newborn, in Pediatric Neurology Principles & Practice ch. 14, at 279 (Kenneth F. Swaiman et al. eds., 4th ed., Elsevier 2006).
  16. See Prakesh Shah & Max Perlman, Time


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