An interventional study of High resuscitation table and Low resuscitation table in Asphyxia, Resuscitation and Newborn Morbidity, sponsored by University Hospital Padova. Completed at 1 site in Italy. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-08.
Sponsored by University Hospital Padova · Not applicable, Interventional, and Treatment
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).
The force exerted by providers during neonatal ventilation to improve mask seal might result in pressure lesions and the elicitation of the trigeminal-cardiac reflex. The height of the resuscitation could influence the forces applied to the face and the quality of the procedure. Information about the applied forces in relation to the height of the resuscitation table is unknown.
39 studies on the registry are indexed under Asphyxia; 7 are open to participants now.
This study's enrollment of 28 is below the median of 111 across 24 interventional studies indexed under Asphyxia.
Browse Asphyxia studies →University Hospital Padova is the lead sponsor of 41 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Participants will be invited to administer face-mask ventilation setting the table height to the operator's xiphoid process in a neonatal manikin.
Other: High resuscitation table
Participants will be invited to administer face-mask ventilation setting the table height to the operator's superior anterior iliac spines in a neonatal manikin.
Other: Low resuscitation table
Participants will be invited to administer face-mask ventilation setting the table height to the operator's xiphoid process in a neonatal manikin.
Participants will be invited to administer face-mask ventilation setting the table height to the operator's superior anterior iliac spines in a neonatal manikin.
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
Time frame: 1 minute after initiation of ventilation
Cuff pressure
The pressure inside the mask will be measured during the procedure
Time frame: 1 minute after initiation of ventilation
Percentage of ventilation time with leak less than 25% around the mask
The mask leak will be measured by using a respiratory function monitoring during the procedure
Time frame: 1 minute after initiation of ventilation
Participants' opinion on the procedures
Participants will be asked to rate both procedures by using a Likert scale
Time frame: 5 minutes after the end of the procedure
Plan to share: No
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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University Hospital Padova