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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anatomical face mask 1 | Experimental |
| |
| Anatomical face mask 2 | Active Comparator |
| |
| Round face mask | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anatomical face mask 1 | Device | Providing face mask ventilation in a neonatal manikin using a model of anatomical face mask |
|
| Measure | Description | Time Frame |
|---|---|---|
| Applied forces | The force applied on the manikin head by the operator during the procedure | 1 minute |
| Measure | Description | Time Frame |
|---|---|---|
| Mask leak | Mask leak (measured as percentage of ventilation time with leak less than 25% around the mask) | 1 minute |
| Participant opinion | Participants' opinions on the face masks (assessed using a Likert scale, from 1 lowest grade to 5 highest grade) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Università di Padova | Padova | 35128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40866603 | Background | 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. 2026 Feb;99(3):1122-1127. doi: 10.1038/s41390-025-04308-2. Epub 2025 Aug 27. | |
| 36788198 |
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Manikin study
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| Anatomical face mask 2 | Device | Providing face mask ventilation in a neonatal manikin using another model of anatomical face mask |
|
| Round face mask | Device | Providing face mask ventilation in a neonatal manikin using a model of round face mask |
|
| 2 minutes |
| 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. |
| 32152886 | Background | 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. |