Applied Forces During Neonatal Face Mask Ventilation With Different Face-mask Air Cushion Volumes
NCT ID: NCT06161389
Last Updated: 2024-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2023-12-11
2023-12-14
Brief Summary
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In neonatal manikins, ventilation with a partially or fully inflated face mask does not seem to result in differences in mask leak. The force exerted by providers to improve mask seal might result in pressure lesions and in the elicitation of the trigeminal-cardiac reflex. However, information about the applied forces is unknown.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Partially inflated mask
Participants will be invited to administer positive pressure ventilation by using a partially inflated mask in a neonatal manikin
Partially inflated mask
Manikin ventilation with a partially inflated mask
Fully inflated mask
Participants will be invited to administer positive pressure ventilation by using a fully inflated mask in a neonatal manikin
Fully inflated mask
Manikin ventilation with a fully inflated mask
Interventions
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Partially inflated mask
Manikin ventilation with a partially inflated mask
Fully inflated mask
Manikin ventilation with a fully inflated mask
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
25 Years
65 Years
ALL
Yes
Sponsors
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University Hospital Padova
OTHER
Responsible Party
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Daniele Trevisanuto
Associate Professor
Locations
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Azienda Ospedaliera di Padova, University of Padova
Padua, , Italy
Countries
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References
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Madar J, Roehr CC, Ainsworth S, Ersdal H, Morley C, Rudiger M, Skare C, Szczapa T, Te Pas A, Trevisanuto D, Urlesberger B, Wilkinson D, Wyllie JP. European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants at birth. Resuscitation. 2021 Apr;161:291-326. doi: 10.1016/j.resuscitation.2021.02.014. Epub 2021 Mar 24.
Schilleman K, Witlox RS, Lopriore E, Morley CJ, Walther FJ, te Pas AB. Leak and obstruction with mask ventilation during simulated neonatal resuscitation. Arch Dis Child Fetal Neonatal Ed. 2010 Nov;95(6):F398-402. doi: 10.1136/adc.2009.182162. Epub 2010 Jun 30.
van Vonderen JJ, Kleijn TA, Schilleman K, Walther FJ, Hooper SB, te Pas AB. Compressive force applied to a manikin's head during mask ventilation. Arch Dis Child Fetal Neonatal Ed. 2012 Jul;97(4):F254-8. doi: 10.1136/archdischild-2011-300336. Epub 2011 Dec 5.
Cavallin F, Sala C, Maglio S, Bua B, Villani PE, Menciassi A, Tognarelli S, Trevisanuto D. Applied forces with direct versus indirect laryngoscopy in neonatal intubation: a randomized crossover mannequin study. Can J Anaesth. 2023 May;70(5):861-868. doi: 10.1007/s12630-023-02402-9. Epub 2023 Feb 14.
Other Identifiers
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NEOUNIPD3(2023)
Identifier Type: -
Identifier Source: org_study_id
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