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Resuscitation Table Height for Face-mask Ventilation in Infants (ForTab)

U

University Hospital Padova

Status

Completed

Conditions

Asphyxia
Newborn Morbidity
Resuscitation

Treatments

Other: High resuscitation table
Other: Low resuscitation table

Study type

Interventional

Funder types

Other

Identifiers

NCT06254651
NEOUNIPD4(2023)

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • None

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

28 participants in 2 patient groups

High resuscitation table
Experimental group
Description:
Participants will be invited to administer face-mask ventilation setting the table height to the operator's xiphoid process in a neonatal manikin.
Treatment:
Other: High resuscitation table
Low resuscitation table
Active Comparator group
Description:
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.
Treatment:
Other: Low resuscitation table

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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