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OpenTrials
Completed

NCT Number: NCT06254651

Resuscitation Table Height for Face-mask Ventilation in Infants

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.

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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 neonatal intensive neonatal care unit consultants and pediatric residents

Exclusion criteria

  • None

Treatment and study plan

High resuscitation table

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

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.

Primary outcomes

  1. Applied forces on the manikin face

    Time frame: 1 minute after initiation of ventilation

    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 after initiation of ventilation

    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 after initiation of ventilation

    The mask leak will be measured by using a respiratory function monitoring during the procedure

Other outcomes

  1. Participants' opinion on the procedures

    Time frame: 5 minutes after the end of the procedure

    Participants will be asked to rate both procedures by using a Likert scale

Sponsors and collaborators

Lead sponsor

University Hospital Padova

Other

Registry information

Acronym: ForTab

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 12, 2024
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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