Newborn self-inflating manual resuscitators: precision robotic testing of safety and reliability.
Arch Dis Child Fetal Neonatal Ed
; 104(4): F403-F408, 2019 Jul.
Article
en En
| MEDLINE
| ID: mdl-30337333
AIM: A controlled bench test was undertaken to determine the performance variability among a range of neonatal self-inflating bags (SIB) compliant with current International Standards Organisation (ISO). INTRODUCTION: Use of SIB to provide positive pressure ventilation during newborn resuscitation is a common emergency procedure. The United Nations programmes advocate increasing availability of SIB in low-income and middle-income nations and recommend devices compliant with ISO. No systematic study has evaluated variance in different models of neonatal SIB. METHODS: 20 models of SIB were incrementally compressed by an automated robotic device simulating the geometry and force of a human hand across a range of precise distances in a newborn lung model. Significance was calculated using analysis of variance repeated measures to determine the relationship between distance of SIB compression and delivered ventilation. A pass/fail was derived from a composite score comprising: minimum tidal volume; coefficient of variation (across all compression distances); peak pressures generated and functional compression distance. RESULTS: Ten out of the 20 models of SIB failed our testing methodology. Two models could not provide safe minimum tidal volumes (2.5-5 mL); six models exceeded safety inflation pressure limit >45 cm H2O, representing 6% of their inflations; five models had excessive coefficient of variation (>30% averaged across compression distances) and three models did not deliver inflation volumes >2.5 mL until approximately 50% of maximum bag compression distance was reached. The study also found significant intrabatch variability and forward leakage. CONCLUSION: Compliance of SIBs with ISO standards may not guarantee acceptable or safe performance to resuscitate newborn infants.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Respiración Artificial
/
Robótica
/
Insuflación
/
Respiración con Presión Positiva
/
Cuidado del Lactante
Tipo de estudio:
Evaluation_studies
/
Prognostic_studies
Límite:
Humans
/
Newborn
Idioma:
En
Revista:
Arch Dis Child Fetal Neonatal Ed
Asunto de la revista:
PEDIATRIA
/
PERINATOLOGIA
Año:
2019
Tipo del documento:
Article
País de afiliación:
Australia
Pais de publicación:
Reino Unido