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

Nicolas J Pejovic, Daniele Trevisanuto, Clare Lubulwa, Susanna Myrnerts Höök, Francesco Cavallin, Josaphat Byamugisha, Jolly Nankunda, Thorkild Tylleskär, Nicolas J Pejovic, Daniele Trevisanuto, Clare Lubulwa, Susanna Myrnerts Höök, Francesco Cavallin, Josaphat Byamugisha, Jolly Nankunda, Thorkild Tylleskär

Abstract

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://ichgcp.net/clinical-trials-registry/NCT02042118" title="See in ClinicalTrials.gov">NCT02042118.

Keywords: Asphyxia Neonatorum; Global Health; Laryngeal Masks; Newborn Infant; Resuscitation.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
CONSORT flow diagram.
Figure 2
Figure 2
The i-gel and face mask.
Figure 3
Figure 3
Mean heart rate (bpm).

References

    1. Lee AC, Kozuki N, Blencowe H, et al. . Intrapartum-related neonatal encephalopathy incidence and impairment at regional and global levels for 2010 with trends from 1990. Pediatr Res 2013;74(suppl 1):50–72. 10.1038/pr.2013.206
    1. Lawn JE, Blencowe H, Oza S, et al. . Every Newborn: progress, priorities, and potential beyond survival. Lancet 2014;384:189–205. 10.1016/S0140-6736(14)60496-7
    1. Bhutta ZA, Black RE, maternal G. Newborn, and child health-so near and yet so far. N Engl J Med 2013;369:2226–35.
    1. Lozano R, Wang H, Foreman KJ, et al. . Progress towards Millennium Development Goals 4 and 5 on maternal and child mortality: an updated systematic analysis. Lancet 2011;378:1139–65. 10.1016/S0140-6736(11)61337-8
    1. Liu L, Johnson HL, Cousens S, et al. . Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet 2012;379:2151–61. 10.1016/S0140-6736(12)60560-1
    1. Reisman J, Arlington L, Jensen L, et al. . Newborn resuscitation training in Resource-Limited Settings: a Systematic Literature Review. Pediatrics 2016;138:e20154490 10.1542/peds.2015-4490
    1. Kattwinkel J, Perlman JM, Aziz K, et al. . Neonatal resuscitation: 2010 American heart association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Pediatrics 2010;126:e1400–e1413. 10.1542/peds.2010-2972E
    1. Lane B, Finer N, Rich W. Duration of intubation attempts during neonatal resuscitation. J Pediatr 2004;145:67–70. 10.1016/j.jpeds.2004.03.003
    1. Carbine DN, Finer NN, Knodel E, et al. . Video recording as a means of evaluating neonatal resuscitation performance. Pediatrics 2000;106:654–8. 10.1542/peds.106.4.654
    1. Perlman JM, Wyllie J, Kattwinkel J, et al. . Part 7: Neonatal Resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations (Reprint). Pediatrics 2015;136(suppl 2):S120–S166. 10.1542/peds.2015-3373D
    1. Gandini D, Brimacombe JR. Neonatal resuscitation with the laryngeal mask airway in normal and low birth weight infants. Anesth Analg 1999;89:642–3. 10.1213/00000539-199909000-00018
    1. Grein AJ, Weiner GM. Laryngeal mask airway versus bag-mask ventilation or endotracheal intubation for neonatal resuscitation. Cochrane Database Syst Rev 2005:CD003314 10.1002/14651858.CD003314.pub2
    1. Paterson SJ, Byrne PJ, Molesky MG, et al. . Neonatal resuscitation using the laryngeal mask airway. Anesthesiology 1994;80:1248–53. discussion 1227A 10.1097/00000542-199406000-00012
    1. Trevisanuto D, Micaglio M, Pitton M, et al. . Laryngeal mask airway: is the management of neonates requiring positive pressure ventilation at birth changing? Resuscitation 2004;62:151–7. 10.1016/j.resuscitation.2004.03.006
    1. Zhu XY, Lin BC, Zhang QS, et al. . A prospective evaluation of the efficacy of the laryngeal mask airway during neonatal resuscitation. Resuscitation 2011;82:1405–9. 10.1016/j.resuscitation.2011.06.010
    1. Trevisanuto D, Marchetto L, Arnolda G, et al. . Neonatal resuscitation in Vietnam: a national survey of a middle-income country. Acta Paediatr 2015;104:e255–e262. 10.1111/apa.12925
    1. Levitan RM, Kinkle WC. Initial anatomic investigations of the I-gel airway: a novel supraglottic airway without inflatable cuff. Anaesthesia 2005;60:1022–6. 10.1111/j.1365-2044.2005.04258.x
    1. Pejovic NJ, Trevisanuto D, Nankunda J, et al. . Pilot manikin study showed that a supraglottic airway device improved simulated neonatal ventilation in a low-resource setting. Acta Paediatr 2016;105:1440–3. 10.1111/apa.13565
    1. Manning WG, Basu A, Mullahy J. Generalized modeling approaches to risk adjustment of skewed outcomes data. J Health Econ 2005;24:465–88. 10.1016/j.jhealeco.2004.09.011
    1. Cundill B, Alexander ND. Sample size calculations for skewed distributions. BMC Med Res Methodol 2015;15:28 10.1186/s12874-015-0023-0
    1. Core Team R. R: a language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria 2015.
    1. Trevisanuto D, Cavallin F, Nguyen LN, et al. . Supreme Laryngeal Mask Airway versus Face Mask during Neonatal Resuscitation: A Randomized Controlled Trial. J Pediatr 2015;167:286–91. 10.1016/j.jpeds.2015.04.051
    1. Chen X, Jiao J, Cong X, et al. . A comparison of the performance of the I-gel vs. the LMA-S during anesthesia: a meta-analysis of randomized controlled trials. PLoS One 2013;8:e71910 10.1371/journal.pone.0071910
    1. Lee AC, Cousens S, Wall SN, 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. BMC Public Health 2011;11(Suppl 3):S12 10.1186/1471-2458-11-S3-S12
    1. van Vonderen JJ, Witlox RS, Kraaij S, et al. . Two-minute training for improving neonatal bag and mask ventilation. PLoS One 2014;9:e109049 10.1371/journal.pone.0109049
    1. Mduma E, Ersdal H, Svensen E, et al. . Frequent brief on-site simulation training and reduction in 24-h neonatal mortality--an educational intervention study. Resuscitation 2015;93:1–7. 10.1016/j.resuscitation.2015.04.019
    1. Deindl P, Schwindt J, Berger A, et al. . An instructional video enhanced bag-mask ventilation quality during simulated newborn resuscitation. Acta Paediatr 2015;104:e20–e26. 10.1111/apa.12826

Source: PubMed

3
Abonneren