NCT06161389

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

December 11, 2023

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2023

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

3 days

First QC Date

November 29, 2023

Last Update Submit

April 4, 2024

Conditions

Positive Pressure VentilationPreterm InfantsApnea

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Cuff pressure

    1 minute

  • Percentage of ventilation time with leak less than 25% around the mask

    1 minute

Other Outcomes (1)

  • Participants' opinion on the procedures

    5 minutes

Study Arms (2)

Partially inflated mask

EXPERIMENTAL

Participants will be invited to administer positive pressure ventilation by using a partially inflated mask in a neonatal manikin

Device: Partially inflated mask

Fully inflated mask

ACTIVE COMPARATOR

Participants will be invited to administer positive pressure ventilation by using a fully inflated mask in a neonatal manikin

Device: Fully inflated mask

Interventions

Partially inflated maskDEVICE

Manikin ventilation with a partially inflated mask

Partially inflated mask
Fully inflated maskDEVICE

Manikin ventilation with a fully inflated mask

Fully inflated mask

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Level III NICU consultants and pediatric residents

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera di Padova, University of Padova

Padua, 35128, Italy

Location

Related Publications (4)

  • 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.

    PMID: 33773829BACKGROUND

  • 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.

    PMID: 20591880BACKGROUND

  • 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.

    PMID: 22147285BACKGROUND

  • 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.

    PMID: 36788198BACKGROUND

MeSH Terms

Conditions

Apnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 29, 2023

First Posted

December 7, 2023

Study Start

December 11, 2023

Primary Completion

December 14, 2023

Study Completion

December 14, 2023

Last Updated

April 8, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)