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Applied Forces During Neonatal Face Mask Ventilation With Different Face-mask Air Cushion Volumes

Applied Forces During Neonatal Face Mask Ventilation With Different Face-mask Air Cushion

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06161389
Acronym
ForVol
Enrollment
28
Registered
2023-12-07
Start date
2023-12-11
Completion date
2023-12-14
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

Apnea, Positive Pressure Ventilation, Preterm Infants

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). In neonatal manikins, ventilation with a partially or fully inflated face mask does not seem to result in differences in mask leak. The force exerted by providers to improve mask seal might result in pressure lesions and in the elicitation of the trigeminal-cardiac reflex. However, information about the applied forces is unknown.

Interventions

DEVICEPartially inflated mask

Manikin ventilation with a partially inflated mask

DEVICEFully inflated mask

Manikin ventilation with a fully inflated mask

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 NICU consultants and pediatric residents

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Applied forces on the manikin face1 minuteThe forces applied by the participants to the manikin face will be measured by sensors positioned on the manikin face

Secondary

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

Other

MeasureTime frameDescription
Participants' opinion on the procedures5 minutesParticipants will be asked to rate both procedures by using a Likert scale (Likert scale from 1 lowest grade to 5 highest grade)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026