Marilyn C. Morris

2005 American Heart Association (AHA) guidelines for cardiopulmonary resuscitation (CPR) and emergency cardiovascular care (ECC) of pediatric and neonatal patients: Pediatric advanced life support

This publication presents the 2005 American Heart Association (AHA) guidelines for cardiopulmonary resuscitation (CPR) and emergency cardiovascular care (ECC) of the pediatric patient and the 2005 American Academy of Pediatrics/AHA guidelines for CPR and ECC of the neonate. The guidelines are based on the evidence evaluation from the 2005 International Consensus Conference on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations, hosted by the American Heart Association in Dallas, Texas, January 23–30, 2005. The “2005 AHA Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care” contain recommendations designed to improve survival from sudden cardiac arrest and acute life-threatening cardiopulmonary problems. The evidence evaluation process that was the basis for these guidelines was accomplished in collaboration with the International Liaison Committee on Resuscitation (ILCOR). The ILCOR process is described in more detail in the “International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations.” The recommendations in the “2005 AHA Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care” confirm the safety and effectiveness of many approaches, acknowledge that other approaches may not be optimal, and recommend new treatments that have undergone evidence evaluation. These new recommendations do not imply that care involving the use of earlier guidelines is unsafe. In addition, it is important to note that these guidelines will not apply to all rescuers and all victims in all situations. The leader of a resuscitation attempt may need to adapt application of the guidelines to unique circumstances. The following are the major pediatric advanced life support changes in the 2005 guidelines: There is further caution about the use of endotracheal tubes. Laryngeal mask airways are acceptable when used by experienced providers. Cuffed endotracheal tubes may be used in infants (except newborns) and children in in-hospital settings provided that cuff inflation pressure is kept <20 cm H2O. Confirmation of tube placement requires clinical assessment and assessment of exhaled carbon dioxide (CO2); esophageal detector devices may be considered for use in children weighing >20 kg who have a perfusing rhythm. Correct placement must be verified when the tube is inserted, during transport, and whenever the patient is moved. During CPR with an advanced airway in place, rescuers will no longer perform “cycles” of CPR. Instead, the rescuer performing chest compressions will perform them continuously at a rate of 100/minute without pauses for ventilation. The rescuer providing ventilation will deliver 8 to 10 breaths per minute (1 breath approximately every 6–8 seconds). Timing of 1 shock, CPR, and drug administration during pulseless arrest has changed and now is identical to that for advanced cardiac life support. Routine use of high-dose epinephrine is not recommended. Lidocaine is de-emphasized, but it can be used for treatment of ventricular fibrillation/pulseless ventricular tachycardia if amiodarone is not available. Induced hypothermia (32–34°C for 12–24 hours) may be considered if the child remains comatose after resuscitation. Indications for the use of inodilators are mentioned in the postresuscitation section. Termination of resuscitative efforts is discussed. It is noted that intact survival has been reported following prolonged resuscitation and absence of spontaneous circulation despite 2 doses of epinephrine. The following are the major neonatal resuscitation changes in the 2005 guidelines: Supplementary oxygen is recommended whenever positive-pressure ventilation is indicated for resuscitation; free-flow oxygen should be administered to infants who are breathing but have central cyanosis. Although the standard approach to resuscitation is to use 100% oxygen, it is reasonable to begin resuscitation with an oxygen concentration of less than 100% or to start with no supplementary oxygen (ie, start with room air). If the clinician begins resuscitation with room air, it is recommended that supplementary oxygen be available to use if there is no appreciable improvement within 90 seconds after birth. In situations where supplementary oxygen is not readily available, positive-pressure ventilation should be administered with room air. Current recommendations no longer advise routine intrapartum oropharyngeal and nasopharyngeal suctioning for infants born to mothers with meconium staining of amniotic fluid. Endotracheal suctioning for infants who are not vigorous should be performed immediately after birth. A self-inflating bag, a flow-inflating bag, or a T-piece (a valved mechanical device designed to regulate pressure and limit flow) can be used to ventilate a newborn. An increase in heart rate is the primary sign of improved ventilation during resuscitation. Exhaled CO2 detection is the recommended primary technique to confirm correct endotracheal tube placement when a prompt increase in heart rate does not occur after intubation. The recommended intravenous (IV) epinephrine dose is 0.01 to 0.03 mg/kg per dose. Higher IV doses are not recommended, and IV administration is the preferred route. Although access is being obtained, administration of a higher dose (up to 0.1 mg/kg) through the endotracheal tube may be considered. It is possible to identify conditions associated with high mortality and poor outcome in which withholding resuscitative efforts may be considered reasonable, particularly when there has been the opportunity for parental agreement. The following guidelines must be interpreted according to current regional outcomes: When gestation, birth weight, or congenital anomalies are associated with almost certain early death and when unacceptably high morbidity is likely among the rare survivors, resuscitation is not indicated. Examples are provided in the guidelines. In conditions associated with a high rate of survival and acceptable morbidity, resuscitation is nearly always indicated. In conditions associated with uncertain prognosis in which survival is borderline, the morbidity rate is relatively high, and the anticipated burden to the child is high, parental desires concerning initiation of resuscitation should be supported. Infants without signs of life (no heartbeat and no respiratory effort) after 10 minutes of resuscitation show either a high mortality rate or severe neurodevelopmental disability. After 10 minutes of continuous and adequate resuscitative efforts, discontinuation of resuscitation may be justified if there are no signs of life.

Survival outcomes after extracorporeal cardiopulmonary resuscitation instituted during active chest compressions following refractory in-hospital pediatric cardiac arrest.

Objective: To report survival outcomes and to identify factors associated with survival following extracorporeal cardiopulmonary resuscitation for in-hospital pediatric cardiac arrest. Design: Retrospective chart review, consecutive case series. Main Outcome Measure: Survival to hospital discharge. Results: During a 7-yr study period, there were 66 cardiac arrest events in 64 patients in which a child was cannulated for extracorporeal membrane oxygenation during active cardiopulmonary resuscitation with chest compressions. A total of 33 of 66 events (50%) resulted in the child being decannulated and surviving at least 24 hrs; 21 of 64 (33%) children undergoing extracorporeal cardiopulmonary resuscitation survived to hospital discharge. A total of 19 of 43 children with isolated heart disease compared with two of 21 children with other medical conditions survived to hospital discharge (p < .01). Pediatric Cerebral Performance Category and Pediatric Overall Performance Category were determined for survivors >2 months old. Five of ten extracorporeal cardiopulmonary resuscitation survivors >2 months old had no change in Pediatric Cerebral Performance Category or Pediatric Overall Performance Category compared with admission. Three of six extracorporeal cardiopulmonary resuscitation patients who survived after receiving >60 mins of chest compressions before extracorporeal cardiopulmonary resuscitation had grossly intact neurologic function. During a 2-yr period in the same hospital, no patient who received >30 mins of cardiopulmonary resuscitation without extracorporeal cardiopulmonary resuscitation survived. In this case series, age, weight, or duration of chest compressions before extracorporeal cardiopulmonary resuscitation did not correlate with survival. Conclusions: Extracorporeal cardiopulmonary resuscitation can be used to successfully resuscitate selected children following refractory in-hospital cardiac arrest, and can be implemented during active cardiopulmonary resuscitation. Intact neurologic survival can sometimes be achieved, even when the duration of in-hospital cardiopulmonary resuscitation is prolonged. In this series, children with isolated heart disease were more likely to survive following extracorporeal cardiopulmonary resuscitation than were children with other medical conditions.

Outcomes After In-Hospital Cardiac Arrest in Children With Cardiac Disease A Report From Get With the Guidelines–Resuscitation

Background— Small studies suggest that children experiencing a cardiac arrest after undergoing cardiac surgery have better outcomes than other groups of patients, but the survival outcomes and periarrest variables of cardiac and noncardiac pediatric patients have not been compared. Methods and Results— All cardiac arrests in patients <18 years of age were identified from Get With the Guidelines–Resuscitation from 2000 to 2008. Cardiac arrests occurring in the neonatal intensive care unit were excluded. Of 3323 index cardiac arrests, 19% occurred in surgical-cardiac, 17% in medical-cardiac, and 64% in noncardiac (trauma, surgical-noncardiac, and medical-noncardiac) patients. Survival to hospital discharge was significantly higher in the surgical-cardiac group (37%) compared with the medical-cardiac group (28%; adjusted odds ratio, 1.8; 95% confidence interval, 1.3–2.5) and the noncardiac group (23%; adjusted odds ratio, 1.8; 95% confidence interval, 1.4–2.4). Those in the cardiac groups were younger and less likely to have preexisting noncardiac organ dysfunction, but were more likely to have ventricular arrhythmias as their first pulseless rhythm, to be monitored and hospitalized in the intensive care unit at the time of cardiac arrest, and to have extracorporeal cardiopulmonary resuscitation compared with those in the noncardiac group. There was no survival advantage for patients in the medical-cardiac group compared with those in the noncardiac group when adjusted for periarrest variables. Conclusion— Children with surgical-cardiac disease have significantly better survival to hospital discharge after an in-hospital cardiac arrest compared with children with medical-cardiac disease and noncardiac disease. # Clinical Perspective {#article-title-25}Background— Small studies suggest that children experiencing a cardiac arrest after undergoing cardiac surgery have better outcomes than other groups of patients, but the survival outcomes and periarrest variables of cardiac and noncardiac pediatric patients have not been compared. Methods and Results— All cardiac arrests in patients <18 years of age were identified from Get With the Guidelines–Resuscitation from 2000 to 2008. Cardiac arrests occurring in the neonatal intensive care unit were excluded. Of 3323 index cardiac arrests, 19% occurred in surgical-cardiac, 17% in medical-cardiac, and 64% in noncardiac (trauma, surgical-noncardiac, and medical-noncardiac) patients. Survival to hospital discharge was significantly higher in the surgical-cardiac group (37%) compared with the medical-cardiac group (28%; adjusted odds ratio, 1.8; 95% confidence interval, 1.3–2.5) and the noncardiac group (23%; adjusted odds ratio, 1.8; 95% confidence interval, 1.4–2.4). Those in the cardiac groups were younger and less likely to have preexisting noncardiac organ dysfunction, but were more likely to have ventricular arrhythmias as their first pulseless rhythm, to be monitored and hospitalized in the intensive care unit at the time of cardiac arrest, and to have extracorporeal cardiopulmonary resuscitation compared with those in the noncardiac group. There was no survival advantage for patients in the medical-cardiac group compared with those in the noncardiac group when adjusted for periarrest variables. Conclusion— Children with surgical-cardiac disease have significantly better survival to hospital discharge after an in-hospital cardiac arrest compared with children with medical-cardiac disease and noncardiac disease.

Exception From Informed Consent for Pediatric Resuscitation Research: Community Consultation for a Trial of Brain Cooling After In-Hospital Cardiac Arrest

Objectives. When prospective informed consent is not feasible, clinical research that presents more than minimal risk can proceed only after a community consultation and public disclosure process and the granting of exception from informed consent from the federal government. The applicability of exception from informed consent to pediatric resuscitation research has not been described. The objectives of this study were 1) to perform a community consultation and public disclosure process specific to a trial of induced hypothermia immediately after pediatric cardiac arrest and 2) to determine the applicability of exception from informed consent to randomized, controlled trials of emergency interventions after resuscitation from inpatient pediatric cardiac arrest. Methods. Focus groups, information sheets with options for written responses, posted notices, e-mails, and telephone conversations with parents of critically ill children and hospital staff were conducted at a tertiary care childrens hospital. Data were stored, organized, and retrieved using NVivo qualitative analysis software (QSR International). Results. In focus groups (n = 8), parents (n = 23) and hospital staff (n = 33) concluded that prospective informed consent is not feasible for a trial of induced hypothermia after inpatient pediatric cardiac arrest. Focus group participants endorsed exception from informed consent for a trial of induced hypothermia but only if study information is easily available prospectively and if all parents have an explicit opportunity to decline participation in a verbal conversation before study enrollment. Separate from and without knowledge of the focus group results, 7 (100%) of 7 parents of past or current patients and 21 (50%) of 42 hospital staff who provided written opinions endorsed exception from informed consent for this study. Five (12%) of 42 hospital staff opposed, and 16 (38%) of 42 were neutral. In telephone conversations, 14 (70%) of 20 parents of children who were previously resuscitated from cardiac arrest endorsed exception from informed consent for this study, 3 (15%) of 20 opposed, and 3 (15%) of 20 were unsure. Conclusions. Community consultation for inpatient resuscitation research can be conducted in a childrens hospital, with hospital staff and parents of patients as the relevant community. Exception from informed consent is necessary and appropriate for a randomized trial of induced hypothermia begun within 30 minutes after pediatric cardiac arrest. A process in which families are informed prospectively and have a pre-enrollment option to decline participation will likely be acceptable to families, health care providers, and the institution.

Calcium Use During In-hospital Pediatric Cardiopulmonary Resuscitation: A Report From the National Registry of Cardiopulmonary Resuscitation

OBJECTIVES. Specific patterns of calcium use during in-hospital pediatric cardiopulmonary resuscitation have not been reported since publication of pediatric advanced life support guidelines by the American Heart Association in 2000 recommended that calcium use during cardiopulmonary resuscitation be limited to select circumstances. We hypothesized that calcium is used frequently during in-hospital pediatric cardiopulmonary resuscitation and that its use is associated with worse survival to hospital discharge. METHODS. We reviewed 1477 consecutive pediatric cardiopulmonary resuscitation index events (for patients younger than 18 years) submitted to the National Registry of Cardiopulmonary Resuscitation from January 2000 through July 2004. The primary outcome was survival to hospital discharge. Secondary outcomes included survival of event and neurologic outcome. Multivariable logistic regression was performed to analyze the association between calcium use and outcomes. RESULTS. Calcium was used in 659 (45%) of 1477 events. Calcium was more likely to be used during cardiopulmonary resuscitation in the settings of pediatric facilities, ICUs, cardiac surgery, cardiopulmonary resuscitation duration of ≥15 minutes, asystole, and concurrently with other advanced life support medications: epinephrine, vasopressin, sodium bicarbonate, and magnesium sulfate. The use of calcium during cardiopulmonary resuscitation adjusted for confounding factors was associated with decreased survival to discharge and was not associated with favorable neurologic outcome. CONCLUSIONS. Calcium is used frequently during in-hospital pediatric cardiopulmonary resuscitation. Although epidemiologic associations do not necessarily indicate causality, calcium use during cardiopulmonary resuscitation is associated with decreased survival to hospital discharge and unfavorable neurologic outcome.

Neuron-specific enolase and S-100B are associated with neurologic outcome after pediatric cardiac arrest.

Objective: To characterize the pattern of serum biochemical markers of central nervous system injury (neuron-specific enolase [NSE], S-100B, plasminogen activator inhibitor-1 [PAI-1]) after pediatric cardiac arrest and determine whether there is an association between biomarker concentrations and neurologic outcome. Design: Prospective, observational study. Setting: Urban, tertiary care childrens hospital. Patients: Cardiac arrest survivors, n = 35. Interventions: Serial blood sampling, pediatric cerebral performance category, and standardized neurologic examination. Measurements and Main Results: Serial serum NSE and S-100B concentrations over 96 hrs and PAI-1 at 24 hrs were measured in children (age <18 yrs) who had return of spontaneous circulation following cardiac arrest. Neurologic outcome was prospectively categorized as poor if the change in pre- to postarrest pediatric cerebral performance category was ≥2. Biomarker concentrations were compared between outcome groups and between survival groups using longitudinal analysis correcting for multiple comparisons. Median levels (25th, 75th percentiles) are reported. Receiver operating characteristic analyses were performed at all time points. Biomarker concentrations showed statistically significant differences. Of the 35 patients, neurologic outcomes were poor in 19, with 15 deaths. Median NSE concentrations differed by outcome when measured at ≥48 hrs, and by survival at ≥24 hrs. S-100B concentrations were not significantly associated with neurologic outcome. S-100B levels were associated with survival outcome at ≥48 hrs. PAI-1 levels were not significantly associated with either neurologic or survival outcomes. Conclusions: The timing, intensity, and duration of serum NSE and S-100B biomarker concentration patterns are associated with neurologic and survival outcomes following pediatric cardiac arrest. Serum NSE concentrations at ≥48 hrs are associated with neurologic outcome, whereas serum S-100B levels at ≥48 hrs are associated with survival. Prospective analysis of these markers may help to predict outcomes and guide postresuscitative therapies.

A Randomized Clinical Trial Evaluating Nasal Continuous Positive Airway Pressure for Acute Respiratory Distress in a Developing Country

OBJECTIVE Invasive mechanical ventilation is often not an option for children with acute respiratory infections in developing countries. An alternative is continuous positive airway pressure (CPAP). The authors evaluated the effectiveness of CPAP in children presenting with acute respiratory distress in a developing country. STUDY DESIGN A randomized, controlled trial was conducted in 4 rural hospitals in Ghana. Children, 3 months to 5 years of age, presenting with tachypnea and intercostal or subcostal retractions or nasal flaring were randomly assigned to receive CPAP immediately or 1 hour after presentation. CPAP was applied by locally trained nurses. The primary outcome measure was change in respiratory rate at 1 hour. RESULTS The study was stopped after the enrollment of 70 subjects because of a predetermined stop value of P < .001. Mean respiratory rate of children who received immediate CPAP fell by 16 breaths/min (95% CI 10-21) in the first hour compared with no change in children who had CPAP delayed by 1 hour (95% CI -2 to +5). Thirty-five of the patients had a positive malaria blood smear. There were 3 deaths as a result of severe malaria. No major complications of CPAP use were noted. CONCLUSIONS CPAP decreases respiratory rate in children with respiratory distress compared with children not receiving CPAP. The technology was successfully used by local nurses. No complications were associated with its use. CPAP is a relatively low-cost, low-technology that is a safe method to decrease respiratory rate in children with nonspecific respiratory distress.

Randomized, controlled trials as minimal risk: an ethical analysis.

Objective:We aim to clarify the circumstances in which randomized, controlled trials should be designated as minimal risk, allowing institutional review boards to approve their conduct with a waiver of informed consent if obtaining informed consent is not feasible. Methods:An ethical analysis of the minimal risk standard as applied to randomized, controlled trials was conducted. Conclusions:In determining whether an randomized, controlled trial should be designated as minimal risk, the potential sources of risk that must be considered are as follows: physical risk from study treatments, the loss of individualized care, risk from nontherapeutic components of the research protocol, and the psychological impact of participation, particularly if the research takes place without informed consent in an emergency setting. The risks of research participation should be considered in comparison with the risk of nonparticipation; e.g., the risks specific to research participation should be considered separately from the risks inherent in treatment of the potential research participant’s underling condition. Participation in an randomized, controlled trial may pose no more than minimal risk when: 1) genuine clinical equipoise exists; 2) all of the treatment options included in the research study fall within the current standard of care; 3) there is no currently available treatment with a more favorable risk-benefit profile than the treatments included in the study; 4) the nontherapeutic components of the research are safely under the minimal risk threshold; and 5) the research protocol provides sufficient latitude for treating physicians to individualize care when appropriate. The potential for research participation to have a negative psychological impact on participants or their families should be considered in risk assessment. The requirement for informed consent should only be waived to the extent necessary, and opportunities for the research participant or surrogate to decide whether to participate in the research should be maximized.

A paradigm for inpatient resuscitation research with an exception from informed consent

Objective:Resuscitation research with an exception from informed consent (EFIC) has not been reported in the inpatient or pediatric setting, and little practical information exists to guide application of EFIC regulations to inpatient or pediatric research. The objective of this study was to assess the feasibility of conducting inpatient pediatric resuscitation research with EFIC using handouts to communicate with parents of potential participants and to determine how many parents would likely allow their child to participate in such research. Design:Verbal questionnaire. Setting:Pediatric intensive care units. Participants:Parents of pediatric intensive care unit patients. Interventions:Three one-page handouts described proposed studies; version 1 described a trial of a new medication given during cardiac arrest, and versions 2a and 2b described of a trial of induced hypothermia, with version 2a in paragraph format and version 2b in bullet format. We asked parents of pediatric intensive care unit patients to review the handouts, and then we administered a verbal questionnaire to assess parental reactions to the handouts and to determine how many parents would allow their child to participate. Measurements and Main Results:One or both parents of 91 patients were asked to participate; 100% agreed. Sixty-three percent said they would likely allow their child to participate in resuscitation research with EFIC if they were given a prospective opportunity to opt out. Parents who reviewed version 2b (bullet format) were more likely than parents who reviewed version 2a (paragraph format) to say that they would let their child participate. Parents were more supportive of a trial of induced hypothermia than of a trial of a new medication given during cardiopulmonary resuscitation. Parents endorsed conducting the community consultation process for inpatient resuscitation research with families and healthcare providers of critically ill patients. Conclusions:Inpatient pediatric resuscitation research is feasible using handouts to inform parents of a study and provide a prospective opportunity to opt out. Succinct, bullet-format handouts will yield higher participation rates than paragraph-format handouts.

Effectiveness of the Informed Consent Process for a Pediatric Resuscitation Trial

OBJECTIVE: When prospective informed consent is not feasible, clinical research that presents more than minimal risk can proceed only with an exception from informed consent. Our objectives were (1) to describe the in-hospital community consultation and public disclosure process for a clinical trial and (2) to evaluate our in-hospital public disclosure process. METHODS: Community consultation included parents, providers, and administrators in a PICU via focus groups, conferences, and other methods. Public disclosure consisted of a brochure and a poster in all PICU waiting rooms. These materials described risks and benefits of the trial, that no consent would be sought, how to “opt out,” and how to provide feedback. A verbal questionnaire was administered to parents of potential patients during the trial to evaluate the public disclosure process. RESULTS: Eighty-one percent of 93 parents were aware of the ongoing trial. Seventy-six of 93 remembered seeing the brochure; of these, 26% did not read, 39% read quickly, and 35% read carefully. Thirty-seven of 93 parents remembered seeing the poster; of these, 51% did not read, 32% read quickly, and 17% read carefully. Sixty-seven percent reported that they would want to participate in the study, 9% would not, and 24% were undecided. Of the 7 parents who did not want to participate, 3 had opted out and 4 were unaware that they could opt out. CONCLUSIONS: Parents endorsed resuscitation research with an exception from informed consent. Public disclosure yielded >80% parental awareness. Efforts should be made to ensure awareness of the ability to opt out.