Evidence map›Paper›PMID 40866603›Full record

Trial reportPediatric research2026

Applied forces with partially vs. fully inflated face masks during neonatal ventilation: a randomized crossover manikin trial.

Francesco Cavallin, Andrea Zamunaro, Sabina Maglio, Paolo Ernesto Villani, Benedetta Bua, Damiano Gallo, Arianna Menciassi, Selene Tognarelli, Daniele Trevisanuto

Registry-linked trialAbstract readRandomized Controlled TrialComparative Study
PubMed Publisher
In one paragraph

Trial report in Pediatric research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07161752 (Applied Forces During Neonatal Ventilation With Different Face Masks), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07161752 nacompletednot on this map

Applied Forces During Neonatal Ventilation With Different Face Masks: a Randomized Crossover Manikin Study.

TypeinterventionalSponsorUniversity Hospital PadovaRan2025 to 2025Enrolled30ConditionsFace Mask Ventilation in Neonatal ResuscitationArmsAnatomical face mask 1, Anatomical face mask 2, Round face mask
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Francesco Cavallin *Independent statistician, Solagna, Italy.
Andrea Zamunaro *Department of Woman's and Child's Health, University of Padua, Padua, Italy.
Sabina MaglioThe BioRobotics Institute, Scuola Superiore Sant'Anna, Pisa, Italy.
Paolo Ernesto VillaniDepartment of Woman's and Child's Health, Fondazione Poliambulanza Hospital, Brescia, Italy.
Benedetta BuaDepartment of Woman's and Child's Health, University of Padua, Padua, Italy.
Damiano GalloDepartment of Woman's and Child's Health, University of Padua, Padua, Italy.
Arianna MenciassiThe BioRobotics Institute, Scuola Superiore Sant'Anna, Pisa, Italy.
Selene TognarelliThe BioRobotics Institute, Scuola Superiore Sant'Anna, Pisa, Italy.
Daniele TrevisanutoDepartment of Woman's and Child's Health, University of Padua, Padua, Italy. daniele.trevisanuto@unipd.it.ORCID http://orcid.org/0000-0002-6462-0079

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPositive pressure ventilation with partially (25 ml) vs. fully (35 ml) inflated face mask was compared in terms of applied forces on a newborn manikin face, cuff pressure and air leak.

methodsA crossover randomized controlled trial of face mask ventilation with partially (25 ml) vs. fully (35 ml) inflated face mask in a term neonatal manikin. The trial involved 28 neonatologists and pediatric residents. The primary outcome was the force applied to the manikin face, while the secondary outcomes were cuff pressure, ventilation time with leak <25% around the mask, and participants' view on struggle in delivering effective ventilation, fatigue in achieving good mask seal, and satisfaction about the mask.

resultsChin and cheekbone sensors measured higher top 10th percentile of applied forces with partially vs. fully inflated face mask. Median and top 10th percentile of cuff pressures were higher with the partially inflated mask. Ventilation time with mask leak <25% was not statistically different using partially vs. fully inflated face masks, and participants reported similar opinions about the two procedures.

conclusionsThe lower force applied during positive pressure ventilation with a fully inflated face mask in a neonatal manikin model may be an appealing target, nonetheless the real-life benefits should be addressed in future investigations. REGISTRATION: clinicaltrial.gov NCT0616138. IMPACT: Health care providers may apply different forces to improve mask seal during neonatal resuscitation. Still, data regarding applied forces with various face-mask air cushion volumes is unknown. In a neonatal manikin model, using a partially inflated (25 ml) face mask during PPV was associated to higher applied forces and cuff pressures compared to a fully inflated (35 ml) face mask. The participants reported comparable opinions about the two air cushion volumes. Applying less force on neonatal face might be a desirable objective, nonetheless future investigations should assess its real-life impact.

Indexed as

MasksPositive-Pressure RespirationCross-Over StudiesFemaleHumansInfant, NewbornMaleManikinsNeonatologyPressure

Identifiers

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.