Resuscitation Table Height for Face-mask Ventilation in Infants

Not Applicable

Completed

• Conditions: Asphyxia; Newborn Morbidity; Resuscitation
• Interventions: Other: High resuscitation table; Other: Low resuscitation table

• Registration Number: NCT06254651
• Lead Sponsor: University Hospital Padova

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-01
• Study First Submitted QC: 2024-02-08
• Study Start: 2024-02-12
• Study First Posted: 2024-02-12
• Primary Completion: 2024-02-15
• Study Completion: 2024-02-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Level III neonatal intensive neonatal care unit consultants and pediatric residents

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High resuscitation table	High 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.
Low resuscitation table	Low 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.

Primary Outcome Measures

Name	Time	Method
Applied forces on the manikin face	1 minute after initiation of ventilation	The forces applied by the participants to the manikin face will be measured by sensors positioned on the manikin face

Secondary Outcome Measures

Name	Time	Method
Percentage of ventilation time with leak less than 25% around the mask	1 minute after initiation of ventilation	The mask leak will be measured by using a respiratory function monitoring during the procedure
Cuff pressure	1 minute after initiation of ventilation	The pressure inside the mask will be measured during the procedure

Trial Locations

Locations (1)

Azienda Ospedaliera di Padova, University of Padova; 🇮🇹 Padova, Italy