Applied Forces During Neonatal Ventilation With Different Face Masks
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2025
CompletedFirst Posted
Study publicly available on registry
September 9, 2025
CompletedStudy Start
First participant enrolled
September 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedNovember 20, 2025
November 1, 2025
15 days
September 2, 2025
November 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Applied forces
The force applied on the manikin head by the operator during the procedure
1 minute
Secondary Outcomes (2)
Mask leak
1 minute
Participant opinion
2 minutes
Study Arms (3)
Anatomical face mask 1
EXPERIMENTALAnatomical face mask 2
ACTIVE COMPARATORRound face mask
ACTIVE COMPARATORInterventions
Providing face mask ventilation in a neonatal manikin using a model of anatomical face mask
Providing face mask ventilation in a neonatal manikin using another model of anatomical face mask
Providing face mask ventilation in a neonatal manikin using a model of round face mask
Eligibility Criteria
You may qualify if:
- Level III neonatal intensive care unit (NICU) consultants, pediatric residents and anesthesiology residents
You may not qualify if:
- Refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Azienda Ospedaliera Università di Padova
Padua, 35128, Italy
Related Publications (3)
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.
PMID: 40866603BACKGROUNDCavallin 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: 36788198BACKGROUNDGordon 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.
PMID: 32152886BACKGROUND
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
- Professor
Study Record Dates
First Submitted
September 2, 2025
First Posted
September 9, 2025
Study Start
September 15, 2025
Primary Completion
September 30, 2025
Study Completion
September 30, 2025
Last Updated
November 20, 2025
Record last verified: 2025-11