Dallas 2015 TFQO: Enrique Udaeta COI# 239 EVREV 1: Enrique Udaeta COI# 239 EVREV 1: Edgardo Ezslyd COI# 277 Taskforce: NRP Laryngeal Mask Airway (NRP 618)

Dallas 2015 COI Disclosure (NRP 618: LMA) EVREV 1 COI # 239 Commercial/industry No Potential intellectual conflicts No EVREV 2 COI # 277 Commercial/industry No Potential intellectual conflicts No

Dallas Consensus on Science In 1 randomized controlled trial (LOE 1 46 ) providers had similar success providing effective ventilation with either the laryngeal mask airway or face mask among newborns in the delivery room. In 1 retrospective cohort study (LOE 2 47 ) and 3 large case series (LOE 4 48 ) effective ventilation was achieved quickly using a laryngeal mask airway in newborns weighing >2000 g or delivered at ≥34 weeks' gestation. In 1 randomized controlled trial (LOE 1 49 ) and 1 retrospective cohort study (LOE 2 50 ) providers had similar success providing effective ventilation using either the laryngeal mask airway or endotracheal tube among newborns in the delivery room. Although a single cohort study (LOE 2 50 ) suggests that newborns resuscitated with a laryngeal mask may require less respiratory support after initial resuscitation, this conclusion is subject to significant selection bias. In multiple small case reports effective ventilation was achieved with a laryngeal mask airway when both face mask ventilation and endotracheal intubation were unsuccessful. There is limited evidence to evaluate the effectiveness of the laryngeal mask airway for newborns weighing <2000 g, delivered at <34 weeks' gestation, in the setting of meconium-stained amniotic fluid, during chest compressions, or for administration of emergency intratracheal medications

Dallas CoSTR The laryngeal mask airway should be considered during resuscitation of the newborn if face mask ventilation is unsuccessful and tracheal intubation is unsuccessful or not feasible. The laryngeal mask airway may be considered as an alternative to a face mask for positive-pressure ventilation among newborns weighing >2000 g or delivered at ≥34 weeks' gestation. There is limited evidence, however, to evaluate its use for newborns weighing 2000 g or delivered at ≥34 weeks' gestation. The laryngeal mask airway has not been evaluated in the setting of meconium-stained amniotic fluid, during chest compressions, or for administration of emergency intratracheal medications

Dallas 2015 C2015 PICO Population: In newborn infants at term that have indications for intermittent positive pressure for resuscitation Intervention: use of a laryngeal mask as a primary or secondary device Comparison: endotracheal intubation or mask ventilation improve response to resuscitation Outcomes: Achieving stable vital signs (HR>100, respiratory effort) 8-Critical Reducing the need for subsequent endotracheal intubation 8-Critical Increasing Apgar score 8-Critical Indicators of neonatal brain injury (HIE, IVH) 9-Critical neonatal morbidity (vomiting, gastric distension, reflux, injury) 5-Important and mortality9-Critical long term outcomes (neurologic) 8-Critical

Dallas 2015 Inclusion/Exclusion/Articles Found Inclusion Studies in newborns at term requiring PPV at birth using FM or ETT vs. LMA during neonatal resuscitation Exclusion Studies performed outside DR, Case series, Animal and mannequins studies, Review articles, Studies that did not specifically answer the question, Unpublished studies or only published in abstract form Revised 721 Embase 191, PubMed 378, Cochrane 52 Duplicated and removed 101 Total 620 Excluded: 617 non RCT: Included: 4 RCTs

Dallas 2015 We suggest that the use of Laryngeal Mask Airway as a primary or secondary device for respiratory support in delivery room for newborns at term requiring positive pressure ventilation during neonatal resuscitation is feasible and safe, but there is not enough evidence to recommend it instead of Face Mask for the use as primary device (weak recommendation from low quality of evidence), or instead endotracheal tube as a secondary device (weak recommendation from very low quality evidence) Proposed Treatment Recommendations

Dallas Proposed Treatment Recommendations The laryngeal mask airway should be considered during resuscitation of the newborn if face mask and/or endotracheal intubation is unsuccessful or not feasible. There is limited evidence, however, to evaluate its use for premature infants. The laryngeal mask airway has not been evaluated in the setting of meconium-stained amniotic fluid, during chest compressions, or for administration of emergency intratracheal medications

Dallas 2015 Risk of Bias in studies StudyYearDesign Total Patients Population Industry Funding Allocation: Generation Allocation: Concealment Blinding: Participants Blinding: Assessors Outcome: Complete Outcome: Selective Other Bias Esmail 2002RCT40Apnea at birthUnclear No Low Unclear Singh 2005RCT50Apnea at birthUnclear No Low Unclear Feroze 2008RCT75Apnea at birthUnclear No Low Unclear Zhu 2011 Quasi RCT309Apnea at birthNo Low Unclear

Dallas 2015 ArticleWeigth (g) Age (weeks) Born LMA n FM n ETT n Apgar 1-5 Apgar 10 Succ. Resc* Esmail 2002 Egypt* >2500 (3,369) >35 (38.8) C-section 20- XXX Singh 2005 India* >1500 (?) >35 (?) C-section 25 -XX Feroze 2008 Pakistan* >1500 (?) >35 (?) C-section 25 XXX Zhu 2011 China** >2500 (3,100) >34 (39.1) C-section 76% XX *Success resuscitation: not need for subsequent ET intubation

Dallas 2015 Evidence profile table

Dallas Achieving vital signs (Success resuscitation) 1.2 Reducing need of subsequent endotracheal intubation

Dallas 2015 Evidence profile table

Dallas 2015 LMA compared to FM as a primary device for infants at term requiring positive pressure ventilation for resuscitation (3 RCT with 469 patients) For the critical outcome of “achieving vital signs” we have identified low quality evidence (downgraded for Risk of bias) from 2 small RCTs and 1 large Quasi RCT {Singh 2005, 303; Feroze 2008, 148; Zhu 2011, 1405},) showing that LMA was more effective than the FM (OR % CI ). For the critical outcome of “need for subsequent endotracheal intubation after failed LMA or FM”, we have identified low quality evidence from the same RCTs (downgraded for Risk of bias), showing that LMA was more effective than the FM (OR % CI ) For the critical outcome of ”Apgar score increasing” we have identified low quality evidence from the same RCTs (downgraded for Risk of bias), not being possible to analyze these outcome for the way of report in each study. Proposed Consensus on Science statements

Dallas 2015 LMA compared to FM as a primary device for infants at term requiring positive pressure ventilation for resuscitation (3 RCT with 469 patients) For the critical outcome of “dead” we have identified low quality evidence from the same RCTs (downgraded for Risk of bias), showing no difference between LMA or FM. For the important outcome of “morbidity” we have identified low quality evidence from the same RCTs (downgraded for Risk of bias), showing no difference for any variable between LMA or FM (OR % IC 0.7 – 47.32). We did not identify any evidence to address the critical outcomes of “indicators of brain injury” or “long term outcomes” Proposed Consensus on Science statements

Dallas 2015 LMA compared to ETT as a secondary device for infants at term requiring positive pressure ventilation for resuscitation (1 RCT with 40 patients) For the critical outcome of “achieving vital signs or successful resuscitation”, we have identified very low quality evidence (downgraded for Risk of bias and Inconsistency) from one RCT {Esmail 2002, 115} showing that LMA was as effective as the ETT tube. For the critical outcome of “need for subsequent endotracheal intubation after failed LMA”, we have identified very low quality evidence from the same RCT (downgraded for Risk of bias and Inconsistency) showing that LMA was as effective as ETT. For the critical outcome of “Apgar score increasing” we have identified very low quality evidence from the same RCT (downgraded for Risk of bias and Inconsistency), not being possible to analyze these outcome for the presentation of the results in the study. Proposed Consensus on Science statements

Dallas 2015 LMA compared to ETT as a secondary device for infants at term requiring positive pressure ventilation for resuscitation (1 RCT with 40 patients) For the critical outcome of “dead” we have identified very low quality evidence from the same RCT (downgraded for Risk of bias and Inconsistency), showing no difference between LMA or FM or ETT. For the important outcome of “morbidity” we have identified very low quality evidence from the same RCT (downgraded for Risk of bias and Inconsistency), showing more trauma tissue comparing with LMA vs ETT (OR 2.43 (0.51 – 11.51). We did not identify any evidence to address the critical outcome of indicators of brain injury or long term outcomes comparing LMA, FM or ETT as a secondary device. Proposed Consensus on Science statements

Dallas 2015 We suggest that the use of Laryngeal Mask Airway as a primary or secondary device for respiratory support in delivery room for newborns at term requiring positive pressure ventilation during neonatal resuscitation is feasible and safe, but there is not enough evidence to recommend it instead of Face Mask as a primary device (weak recommendation from low quality of evidence), or instead endotracheal tube as a secondary device (weak recommendation from very low quality evidence) Proposed Treatment Recommendations

Dallas Proposed Treatment Recommendations The laryngeal mask airway should be considered during resuscitation of the newborn if face mask and/or endotracheal intubation is unsuccessful or not feasible. There is limited evidence, however, to evaluate its use for premature infants. The laryngeal mask airway has not been evaluated in the setting of meconium-stained amniotic fluid, during chest compressions, or for administration of emergency intratracheal medications

Dallas 2015 Values and Preferences Statements In making these recommendations we place a moderate value in continuing using these device, but there is a necessity for more clinical trials, especially for its use instead of endotracheal intubation, because the LMA is now being used as a primary device, and this “invasive technique” could produce more morbidity Proposed Treatment Recommendations

Dallas 2015 Knowledge Gaps in LMA vs. FM vs ETT The effectiveness of LMA compared to endotracheal intubation as a secondary device in term and preterm infants. The effectiveness and safety of LMA compared to mask ventilation as the primary interphase in term and preterm infants. LMA insertion technique, which model, and how to teach its use.