NCT06254651

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). The force exerted by providers during neonatal ventilation to improve mask seal might result in pressure lesions and the elicitation of the trigeminal-cardiac reflex. The height of the resuscitation could influence the forces applied to the face and the quality of the procedure. Information about the applied forces in relation to the height of the resuscitation table 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 Feb 2024

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

December 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

February 12, 2024

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

3 days

First QC Date

December 1, 2023

Last Update Submit

April 4, 2024

Conditions

AsphyxiaResuscitationNewborn Morbidity

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 after initiation of ventilation

Secondary Outcomes (2)

  • Cuff pressure

    1 minute after initiation of ventilation

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

    1 minute after initiation of ventilation

Other Outcomes (1)

  • Participants' opinion on the procedures

    5 minutes after the end of the procedure

Study Arms (2)

High resuscitation table

EXPERIMENTAL

Participants will be invited to administer face-mask ventilation setting the table height to the operator's xiphoid process in a neonatal manikin.

Other: High resuscitation table

Low resuscitation table

ACTIVE COMPARATOR

Participants will be invited to administer face-mask ventilation setting the table height to the operator's superior anterior iliac spines in a neonatal manikin.

Other: Low resuscitation table

Interventions

High resuscitation tableOTHER

Participants will be invited to administer face-mask ventilation setting the table height to the operator's xiphoid process in a neonatal manikin.

High resuscitation table
Low resuscitation tableOTHER

Participants will be invited to administer face-mask ventilation setting the table height to the operator's superior anterior iliac spines in a neonatal manikin.

Low resuscitation table

Eligibility Criteria

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

You may qualify if:

  • Level III neonatal intensive neonatal care unit 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 (7)

  • 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

  • Wyckoff MH, Wyllie J, Aziz K, de Almeida MF, Fabres JW, Fawke J, Guinsburg R, Hosono S, Isayama T, Kapadia VS, Kim HS, Liley HG, McKinlay CJD, Mildenhall L, Perlman JM, Rabi Y, Roehr CC, Schmolzer GM, Szyld E, Trevisanuto D, Velaphi S, Weiner GM; Neonatal Life Support Collaborators. Neonatal Life Support 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Resuscitation. 2020 Nov;156:A156-A187. doi: 10.1016/j.resuscitation.2020.09.015. Epub 2020 Oct 21.

    PMID: 33098917BACKGROUND

  • 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

  • Lee HC, Yun MJ, Hwang JW, Na HS, Kim DH, Park JY. Higher operating tables provide better laryngeal views for tracheal intubation. Br J Anaesth. 2014 Apr;112(4):749-55. doi: 10.1093/bja/aet428. Epub 2013 Dec 18.

    PMID: 24355831BACKGROUND

  • Zamunaro A, Cavallin F, Maglio S, Villani PE, Bua B, Gallo D, Menciassi A, Tognarelli S, Trevisanuto D. Applied forces with high vs. low resuscitation table during neonatal ventilation: a randomized crossover manikin study. Eur J Pediatr. 2024 Nov 27;184(1):45. doi: 10.1007/s00431-024-05844-5.

    PMID: 39592514DERIVED

MeSH Terms

Conditions

Asphyxia

Condition Hierarchy (Ancestors)

DeathPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

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

December 1, 2023

First Posted

February 12, 2024

Study Start

February 12, 2024

Primary Completion

February 15, 2024

Study Completion

February 15, 2024

Last Updated

April 8, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)