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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).
In neonatal manikins, ventilation with a partially or fully inflated face mask does not seem to result in differences in mask leak. The force exerted by providers to improve mask seal might result in pressure lesions and in the elicitation of the trigeminal-cardiac reflex. However, information about the applied forces is unknown.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partially inflated mask | Experimental | Participants will be invited to administer positive pressure ventilation by using a partially inflated mask in a neonatal manikin |
|
| Fully inflated mask | Active Comparator | Participants will be invited to administer positive pressure ventilation by using a fully inflated mask in a neonatal manikin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partially inflated mask | Device | Manikin ventilation with a partially inflated mask |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cuff pressure | The pressure inside the mask will be measured during the procedure | 1 minute |
| Percentage of ventilation time with leak less than 25% around the mask | The mask leak willbe measured by using a respiratory function monitoring during theprocedure |
| Measure | Description | Time Frame |
|---|---|---|
| Participants' opinion on the procedures | Participants will be asked to rate both procedures by using a Likert scale (Likert scale from 1 lowest grade to 5 highest grade) | 5 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera di Padova, University of Padova | Padova | 35128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33773829 | Background | 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. | |
| 20591880 |
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| ID | Term |
|---|---|
| D001049 | Apnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| Fully inflated mask | Device | Manikin ventilation with a fully inflated mask |
|
| 1 minute |
| 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. |
| 22147285 | Background | 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. |
| 36788198 | Background | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |