Applied Forces During Neonatal Face Mask Ventilation With Different Face-mask Air Cushion Volumes

Apnea Clinical Trial

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Official title:

Applied Forces During Neonatal Face Mask Ventilation With Different Face-mask Air Cushion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06161389
• Other study ID #: NEOUNIPD3(2023)
• Status: Completed
• Phase: N/A
• Start date: December 11, 2023
• Est. completion date: December 14, 2023

Study information

• Verified date: April 2024
• Source: University Hospital Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Positive pressure ventilation (PPV) is the most important intervention in neonatal resuscitation. During PPV, it is important to hold the face-mask with care, as applying excessive pressure could cause injury to the infant, while insufficient pressure could be a contributor of mask leak and reduced effective ventilation. Application of positive pressure to face structures may trigger a vagally mediated reflex via the trigeminal nerve that innervates the skin of the face leading to apnoea and a decrease in heart rate (TCR, trigeminal-cardiac reflex). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 14, 2023
• Est. primary completion date: December 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• Level III NICU consultants and pediatric residents

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Apnea
• Preterm Infants

Intervention

Device:
• Partially inflated mask
Manikin ventilation with a partially inflated mask
• Fully inflated mask
Manikin ventilation with a fully inflated mask

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera di Padova, University of Padova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Padova

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participants' opinion on the procedures	Participants will be asked to rate both procedures by using a Likert scale (Likert scale from 1 lowest grade to 5 highest grade)	5 minutes
Primary	Applied forces on the manikin face	The forces applied by the participants to the manikin face will be measured by sensors positioned on the manikin face	1 minute
Secondary	Cuff pressure	The pressure inside the mask will be measured during the procedure	1 minute
Secondary	Percentage of ventilation time with leak less than 25% around the mask	The mask leak willbe measured by using a respiratory function monitoring during theprocedure	1 minute