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

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

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.

Study Overview

• Status: Completed
• Conditions: Apnea; Preterm Infants; Positive Pressure Ventilation
• Intervention / Treatment: Device: Partially inflated mask; Device: Fully inflated mask

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Padova, Italy, 35128
    • Azienda Ospedaliera di Padova, University of Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Level III NICU consultants and pediatric residents

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Partially inflated mask; Participants will be invited to administer positive pressure ventilation by using a partially inflated mask in a neonatal manikin	Device: Partially inflated mask; Manikin ventilation with a partially inflated mask
Active Comparator: Fully inflated mask; Participants will be invited to administer positive pressure ventilation by using a fully inflated mask in a neonatal manikin	Device: Fully inflated mask; Manikin ventilation with a fully inflated mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cuff pressure	The pressure inside the mask will be measured during the procedure	1 minute
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital Padova

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2023
• Primary Completion (Actual): December 14, 2023
• Study Completion (Actual): December 14, 2023

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NEOUNIPD3(2023)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No