Neonatal resuscitation using a laryngeal mask airway: a randomised trial in Uganda

Objective Mortality rates from birth asphyxia in low-income countries remain high. Face mask ventilation (FMV) performed by midwives is the usual method of resuscitating neonates in such settings but may not always be effective. The i-gel is a cuffless laryngeal mask airway (LMA) that could enhance neonatal resuscitation performance. We aimed to compare LMA and face mask (FM) during neonatal resuscitation in a low-resource setting. Setting Mulago National Referral Hospital, Kampala, Uganda. Design This prospective randomised clinical trial was conducted at the labour ward operating theatre. After a brief training on LMA and FM use, infants with a birth weight >2000 g and requiring positive pressure ventilation at birth were randomised to resuscitation by LMA or FM. Resuscitations were video recorded. Main outcome measures Time to spontaneous breathing. Results Forty-nine (24 in the LMA and 25 in the FM arm) out of 50 enrolled patients were analysed. Baseline characteristics were comparable between the two arms. Time to spontaneous breathing was shorter in LMA arm than in FM arm (mean 153 s (SD±59) vs 216 s (SD±92)). All resuscitations were effective in LMA arm, whereas 11 patients receiving FM were converted to LMA because response to FMV was unsatisfactory. There were no adverse effects. Conclusion A cuffless LMA was more effective than FM in reducing time to spontaneous breathing. LMA seems to be safe and effective in clinical practice after a short training programme. Its potential benefits on long-term outcomes need to be assessed in a larger trial. Clinical trial registry This trial was registered in https://clinicaltrials.gov, with registration number NCT02042118.

[1]  M. Kumar,et al.  Laryngeal mask airway versus bag-mask ventilation or endotracheal intubation for neonatal resuscitation. , 2018, The Cochrane database of systematic reviews.

[2]  D. Trevisanuto,et al.  Pilot manikin study showed that a supraglottic airway device improved simulated neonatal ventilation in a low‐resource setting , 2016, Acta paediatrica.

[3]  B. Nelson,et al.  Newborn Resuscitation Training in Resource-Limited Settings: A Systematic Literature Review , 2016, Pediatrics.

[4]  J. Perlman,et al.  Part 7: Neonatal Resuscitation , 2015, Pediatrics.

[5]  J. Perlman,et al.  Part 7: Neonatal resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. , 2015, Resuscitation.

[6]  E. Svensen,et al.  Frequent brief on-site simulation training and reduction in 24-h neonatal mortality--an educational intervention study. , 2015, Resuscitation.

[7]  D. Trevisanuto,et al.  Supreme Laryngeal Mask Airway versus Face Mask during Neonatal Resuscitation: A Randomized Controlled Trial. , 2015, The Journal of pediatrics.

[8]  N. V. Tien,et al.  Neonatal resuscitation in Vietnam: a national survey of a middle‐income country , 2015, Acta paediatrica.

[9]  B. Cundill,et al.  Sample size calculations for skewed distributions , 2015, BMC Medical Research Methodology.

[10]  P. Deindl,et al.  An instructional video enhanced bag‐mask ventilation quality during simulated newborn resuscitation , 2015, Acta paediatrica.

[11]  A. T. te Pas,et al.  Two-Minute Training for Improving Neonatal Bag and Mask Ventilation , 2014, PloS one.

[12]  Colin Mathers,et al.  Every Newborn: progress, priorities, and potential beyond survival , 2014, The Lancet.

[13]  R. Black,et al.  Global maternal, newborn, and child health--so near and yet so far. , 2013, The New England journal of medicine.

[14]  T. Vos,et al.  Intrapartum-related neonatal encephalopathy incidence and impairment at regional and global levels for 2010 with trends from 1990 , 2013, Pediatric Research.

[15]  Lei Liu,et al.  A Comparison of the Performance of the I-gel™ vs. the LMA-S™during Anesthesia: A Meta-Analysis of Randomized Controlled Trials , 2013, PloS one.

[16]  Jamie Perin,et al.  Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000 , 2012, The Lancet.

[17]  B. lin,et al.  A prospective evaluation of the efficacy of the laryngeal mask airway during neonatal resuscitation. , 2011, Resuscitation.

[18]  Mohsen Naghavi,et al.  Progress towards Millennium Development Goals 4 and 5 on maternal and child mortality: an updated systematic analysis , 2011, The Lancet.

[19]  Gary L Darmstadt,et al.  Neonatal resuscitation and immediate newborn assessment and stimulation for the prevention of neonatal deaths: a systematic review, meta-analysis and Delphi estimation of mortality effect , 2011, BMC public health.

[20]  Roger D. White,et al.  Part 8: adult advanced cardiovascular life support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. , 2010, Circulation.

[21]  M. Hazinski,et al.  Neonatal Resuscitation: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care , 2010, Pediatrics.

[22]  R. Levitan,et al.  Initial anatomic investigations of the I‐gel airway: a novel supraglottic airway without inflatable cuff * , 2005, Anaesthesia.

[23]  V. Zanardo,et al.  Laryngeal mask airway: is the management of neonates requiring positive pressure ventilation at birth changing? , 2004, Resuscitation.

[24]  N. Finer,et al.  Duration of intubation attempts during neonatal resuscitation. , 2004, The Journal of pediatrics.

[25]  Anirban Basu,et al.  Generalized Modeling Approaches to Risk Adjustment of Skewed Outcomes Data , 2003, Journal of health economics.

[26]  N. Finer,et al.  Video Recording as a Means of Evaluating Neonatal Resuscitation Performance , 2000, Pediatrics.

[27]  J. Brimacombe,et al.  Neonatal resuscitation with the laryngeal mask airway in normal and low birth weight infants. , 1999, Anesthesia and analgesia.

[28]  B. Finucane,et al.  Neonatal Resuscitation Using the Laryngeal Mask Airway , 1994, Anesthesiology.

[29]  Robert A. Berg,et al.  International Consensus on Cardiopulmonary Resuscitation and mergency Cardiovascular Care Science with Treatment ecommendations , 2015 .

[30]  R Core Team,et al.  R: A language and environment for statistical computing. , 2014 .