Applied Forces During Neonatal Ventilation With Different Face Masks

NCT ID: NCT07161752

Last Updated: 2025-11-20

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2025-09-30

Brief Summary

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This trial compares the applied forces exerted on the face of a modified preterm neonatal manikin with three different face masks. Additionally, percentages of ventilation time with mask leak \<25%, and participants' opinion about perceived applied forces, difficulty in achieving an effective ventilation, and difficulty in obtaining a good mask seal are investigated.

Detailed Description

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Conditions

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Face Mask Ventilation in Neonatal Resuscitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Manikin study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anatomical face mask 1

Group Type EXPERIMENTAL

Anatomical face mask 1

Intervention Type DEVICE

Providing face mask ventilation in a neonatal manikin using a model of anatomical face mask

Anatomical face mask 2

Group Type ACTIVE_COMPARATOR

Anatomical face mask 2

Intervention Type DEVICE

Providing face mask ventilation in a neonatal manikin using another model of anatomical face mask

Round face mask

Group Type ACTIVE_COMPARATOR

Round face mask

Intervention Type DEVICE

Providing face mask ventilation in a neonatal manikin using a model of round face mask

Interventions

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Anatomical face mask 1

Providing face mask ventilation in a neonatal manikin using a model of anatomical face mask

Intervention Type DEVICE

Anatomical face mask 2

Providing face mask ventilation in a neonatal manikin using another model of anatomical face mask

Intervention Type DEVICE

Round face mask

Providing face mask ventilation in a neonatal manikin using a model of round face mask

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Level III neonatal intensive care unit (NICU) consultants, pediatric residents and anesthesiology residents

Exclusion Criteria

* Refusal to participate
Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Padova

OTHER

Sponsor Role lead

Responsible Party

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Daniele Trevisanuto

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliera Università di Padova

Padua, , Italy

Site Status

Countries

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Italy

References

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Cavallin F, Zamunaro A, Maglio S, Villani PE, Bua B, Gallo D, Menciassi A, Tognarelli S, Trevisanuto D. Applied forces with partially vs. fully inflated face masks during neonatal ventilation: a randomized crossover manikin trial. Pediatr Res. 2025 Aug 27. doi: 10.1038/s41390-025-04308-2. Online ahead of print.

Reference Type BACKGROUND
PMID: 40866603 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36788198 (View on PubMed)

Gordon JK, Bertram VE, Cavallin F, Parotto M, Cooper RM. Direct versus indirect laryngoscopy using a Macintosh video laryngoscope: a mannequin study comparing applied forces. Can J Anaesth. 2020 May;67(5):515-520. doi: 10.1007/s12630-020-01583-x. Epub 2020 Mar 9.

Reference Type BACKGROUND
PMID: 32152886 (View on PubMed)

Other Identifiers

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UNIPDNewborn25

Identifier Type: -

Identifier Source: org_study_id

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