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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://clinicaltrials.gov, with registration number NCT02042118.
- Global Health
- Resuscitation
- Newborn Infant
- Asphyxia Neonatorum
- Laryngeal Masks
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Footnotes
Contributors NJP had the idea and was responsible for conception and design, outcome assessment, acquisition of data, data analysis and interpretation, and drafted the manuscript. DT was responsible for trial design, outcome assessment, data analysis and manuscript writing. CL was responsible for on-site trial planning, data gathering, data analysis and critically revising the manuscript for important intellectual content. JN was responsible for on-site trial planning, data analysis, and critically revising the manuscript for important intellectual content. SMH was responsible for outcome assessment, acquisition of data, data analysis and interpretation, and critically revising the manuscript for important intellectual content. JB was responsible for on-site trial planning, data analysis and interpretation, and critically revising the manuscript for important intellectual content. FC was responsible for statistical analysis and interpretation, and critically revising the manuscript for important intellectual content. TT was responsible for conception and design, outcome assessment, data analysis and interpretation, and critically revising the manuscript for important intellectual content.
Funding This study was funded by Laerdal Foundation for Acute Medicine.
Competing interests None declared.
Patient consent Obtained.
Ethics approval Institutional Review Board (IRB) of Mulago National Referral Hospital, the Uganda National Council of Science and Technology, the National Drug Authority and by the Regional Committee for Medical and Health Research Ethics (REK VEST) in Norway.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All authors of this article accept to share the complete dataset of this article. The data will be made available for all reasonable requests by online access with a password.
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