Resuscitation Table Height for Face-mask Ventilation in Infants

Resuscitation Clinical Trial

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Official title:

Resuscitation Table Height for Face-mask Ventilation in Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06254651
• Other study ID #: NEOUNIPD4(2023)
• Status: Completed
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: February 15, 2024

Study information

• Verified date: April 2024
• Source: University Hospital Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Asphyxia
• Newborn Morbidity
• Resuscitation

Intervention

Other:
• 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
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.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera di Padova, University of Padova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Padova

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View Citation

Lee HC, Yun MJ, Hwang JW, Na HS, Kim DH, Park JY. Higher operating tables provide better laryngeal views for tracheal intubation. Br J Anaesth. 2014 Apr;112(4):749-55. doi: 10.1093/bja/aet428. Epub 2013 Dec 18. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Wyckoff MH, Wyllie J, Aziz K, de Almeida MF, Fabres JW, Fawke J, Guinsburg R, Hosono S, Isayama T, Kapadia VS, Kim HS, Liley HG, McKinlay CJD, Mildenhall L, Perlman JM, Rabi Y, Roehr CC, Schmolzer GM, Szyld E, Trevisanuto D, Velaphi S, Weiner GM; Neonatal Life Support Collaborators. Neonatal Life Support 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Resuscitation. 2020 Nov;156:A156-A187. doi: 10.1016/j.resuscitation.2020.09.015. Epub 2020 Oct 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participants' opinion on the procedures	Participants will be asked to rate both procedures by using a Likert scale	5 minutes after the end of the procedure
Primary	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 after initiation of ventilation
Secondary	Cuff pressure	The pressure inside the mask will be measured during the procedure	1 minute after initiation of ventilation
Secondary	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	1 minute after initiation of ventilation