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LMA Supreme for neonatal resuscitation: study protocol for a randomized controlled trial
BACKGROUND: The most important action in the resuscitation of a newborn in the delivery room is to establish effective assisted ventilation. The face mask and endotracheal tube are the devices used to achieve this goal. Laryngeal mask airways that fit over the laryngeal inlet have been shown to be e...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4223364/ https://www.ncbi.nlm.nih.gov/pubmed/25027230 http://dx.doi.org/10.1186/1745-6215-15-285 |
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author | Trevisanuto, Daniele Cavallin, Francesco Mardegan, Veronica Loi, Nguyen Ngoc Tien, Nguyen Viet Linh, Tran Dieu Chien, Tran Dinh Doglioni, Nicoletta Chiandetti, Lino Moccia, Luciano |
author_facet | Trevisanuto, Daniele Cavallin, Francesco Mardegan, Veronica Loi, Nguyen Ngoc Tien, Nguyen Viet Linh, Tran Dieu Chien, Tran Dinh Doglioni, Nicoletta Chiandetti, Lino Moccia, Luciano |
author_sort | Trevisanuto, Daniele |
collection | PubMed |
description | BACKGROUND: The most important action in the resuscitation of a newborn in the delivery room is to establish effective assisted ventilation. The face mask and endotracheal tube are the devices used to achieve this goal. Laryngeal mask airways that fit over the laryngeal inlet have been shown to be effective for ventilating newborns at birth and should be considered as an alternative to facemask ventilation or endotracheal intubation among newborns weighing >2,000 g or delivered ≥34 weeks’ gestation. A recent systematic review and meta-analysis of supraglottic airways in neonatal resuscitation reported the results of four randomized controlled trials (RCTs) stating that fewer infants in the group using laryngeal mask airways required endotracheal intubation (1.5%) compared to the group using face masks (12.0%). However, there were methodological concerns over all the RCTs including the fact that the majority of the operators in the trials were anesthesiologists. Our hypothesis is based on the assumption that ventilating newborns needing positive pressure ventilation with a laryngeal mask airway will be more effective than ventilating with a face mask in a setting where neonatal resuscitation is performed by midwives, nurses, and pediatricians. The primary aim of this study will be to assess the effectiveness of the laryngeal mask airway over the face mask in preventing the need for endotracheal intubation. METHODS/DESIGN: This will be an open, prospective, randomized, single center, clinical trial. In this study, 142 newborns weighing >1,500 g or delivered ≥34 weeks gestation needing positive pressure ventilation at birth will be randomized to be ventilated with a laryngeal mask airway (LMA Supreme(TM), LMA Company, UK - intervention group) or with a face mask (control group). Primary outcome: Proportion of newborns needing endotracheal intubation. Secondary outcomes: Apgar score at 5 minutes, time to first breath, onset of the first cry, duration of resuscitation, death or moderate to severe hypoxic-ischemic encephalopathy within 7 days of life. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01963936 (October 11, 2013). |
format | Online Article Text |
id | pubmed-4223364 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-42233642014-11-08 LMA Supreme for neonatal resuscitation: study protocol for a randomized controlled trial Trevisanuto, Daniele Cavallin, Francesco Mardegan, Veronica Loi, Nguyen Ngoc Tien, Nguyen Viet Linh, Tran Dieu Chien, Tran Dinh Doglioni, Nicoletta Chiandetti, Lino Moccia, Luciano Trials Study Protocol BACKGROUND: The most important action in the resuscitation of a newborn in the delivery room is to establish effective assisted ventilation. The face mask and endotracheal tube are the devices used to achieve this goal. Laryngeal mask airways that fit over the laryngeal inlet have been shown to be effective for ventilating newborns at birth and should be considered as an alternative to facemask ventilation or endotracheal intubation among newborns weighing >2,000 g or delivered ≥34 weeks’ gestation. A recent systematic review and meta-analysis of supraglottic airways in neonatal resuscitation reported the results of four randomized controlled trials (RCTs) stating that fewer infants in the group using laryngeal mask airways required endotracheal intubation (1.5%) compared to the group using face masks (12.0%). However, there were methodological concerns over all the RCTs including the fact that the majority of the operators in the trials were anesthesiologists. Our hypothesis is based on the assumption that ventilating newborns needing positive pressure ventilation with a laryngeal mask airway will be more effective than ventilating with a face mask in a setting where neonatal resuscitation is performed by midwives, nurses, and pediatricians. The primary aim of this study will be to assess the effectiveness of the laryngeal mask airway over the face mask in preventing the need for endotracheal intubation. METHODS/DESIGN: This will be an open, prospective, randomized, single center, clinical trial. In this study, 142 newborns weighing >1,500 g or delivered ≥34 weeks gestation needing positive pressure ventilation at birth will be randomized to be ventilated with a laryngeal mask airway (LMA Supreme(TM), LMA Company, UK - intervention group) or with a face mask (control group). Primary outcome: Proportion of newborns needing endotracheal intubation. Secondary outcomes: Apgar score at 5 minutes, time to first breath, onset of the first cry, duration of resuscitation, death or moderate to severe hypoxic-ischemic encephalopathy within 7 days of life. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01963936 (October 11, 2013). BioMed Central 2014-07-15 /pmc/articles/PMC4223364/ /pubmed/25027230 http://dx.doi.org/10.1186/1745-6215-15-285 Text en Copyright © 2014 Trevisanuto et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Trevisanuto, Daniele Cavallin, Francesco Mardegan, Veronica Loi, Nguyen Ngoc Tien, Nguyen Viet Linh, Tran Dieu Chien, Tran Dinh Doglioni, Nicoletta Chiandetti, Lino Moccia, Luciano LMA Supreme for neonatal resuscitation: study protocol for a randomized controlled trial |
title | LMA Supreme for neonatal resuscitation: study protocol for a randomized controlled trial |
title_full | LMA Supreme for neonatal resuscitation: study protocol for a randomized controlled trial |
title_fullStr | LMA Supreme for neonatal resuscitation: study protocol for a randomized controlled trial |
title_full_unstemmed | LMA Supreme for neonatal resuscitation: study protocol for a randomized controlled trial |
title_short | LMA Supreme for neonatal resuscitation: study protocol for a randomized controlled trial |
title_sort | lma supreme for neonatal resuscitation: study protocol for a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4223364/ https://www.ncbi.nlm.nih.gov/pubmed/25027230 http://dx.doi.org/10.1186/1745-6215-15-285 |
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