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Resuscitation Table Height for Face-mask Ventilation in Infants

Resuscitation Table Height for Face-mask Ventilation in Infants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06254651
Acronym
ForTab
Enrollment
28
Registered
2024-02-12
Start date
2024-02-12
Completion date
2024-02-15
Last updated
2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asphyxia, Newborn Morbidity, Resuscitation

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.

Interventions

OTHERHigh 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.

OTHERLow 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.

Sponsors

University Hospital Padova
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Applied forces on the manikin face1 minute after initiation of ventilationThe forces applied by the participants to the manikin face will be measured by sensors positioned on the manikin face

Secondary

MeasureTime frameDescription
Cuff pressure1 minute after initiation of ventilationThe pressure inside the mask will be measured during the procedure
Percentage of ventilation time with leak less than 25% around the mask1 minute after initiation of ventilationThe mask leak will be measured by using a respiratory function monitoring during the procedure

Other

MeasureTime frameDescription
Participants' opinion on the procedures5 minutes after the end of the procedureParticipants will be asked to rate both procedures by using a Likert scale

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026