Resuscitation Table Height for Face-mask Ventilation in Infants

NCT ID: NCT06254651

Last Updated: 2024-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-12

Study Completion Date

2024-02-15

Brief Summary

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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).

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

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Conditions

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Asphyxia Resuscitation Newborn Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

High resuscitation table

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Low resuscitation table

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Padova

OTHER

Sponsor Role lead

Responsible Party

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Daniele Trevisanuto

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliera di Padova, University of Padova

Padua, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 33773829 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33098917 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20591880 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22147285 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36788198 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24355831 (View on PubMed)

Zamunaro A, Cavallin F, Maglio S, Villani PE, Bua B, Gallo D, Menciassi A, Tognarelli S, Trevisanuto D. Applied forces with high vs. low resuscitation table during neonatal ventilation: a randomized crossover manikin study. Eur J Pediatr. 2024 Nov 27;184(1):45. doi: 10.1007/s00431-024-05844-5.

Reference Type DERIVED
PMID: 39592514 (View on PubMed)

Other Identifiers

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NEOUNIPD4(2023)

Identifier Type: -

Identifier Source: org_study_id

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