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OpenTrials
Completed

NCT Number: NCT06161389

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

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.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliera di Padova, University of Padova

Padova, 35128, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Level III NICU consultants and pediatric residents

Exclusion criteria

  • None

Treatment and study plan

Partially inflated mask

Device

Manikin ventilation with a partially inflated mask

Fully inflated mask

Device

Manikin ventilation with a fully inflated mask

Primary outcomes

  1. Applied forces on the manikin face

    Time frame: 1 minute

    The forces applied by the participants to the manikin face will be measured by sensors positioned on the manikin face

Secondary outcomes

  1. Cuff pressure

    Time frame: 1 minute

    The pressure inside the mask will be measured during the procedure

  2. Percentage of ventilation time with leak less than 25% around the mask

    Time frame: 1 minute

    The mask leak willbe measured by using a respiratory function monitoring during theprocedure

Other outcomes

  1. Participants' opinion on the procedures

    Time frame: 5 minutes

    Participants will be asked to rate both procedures by using a Likert scale (Likert scale from 1 lowest grade to 5 highest grade)

Sponsors and collaborators

Lead sponsor

University Hospital Padova

Other

Registry information

Official study title

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

Acronym: ForVol

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2023
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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