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

Study Overview
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Brief Summary
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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.

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

Conditions
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Apnea, Positive Pressure Ventilation, Preterm Infants

Intervention / Treatment
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* Device: Partially inflated mask
* Device: Fully inflated mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Level III NICU consultants and pediatric residents Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Partially inflated mask<br>Participants will be invited to administer positive pressure ventilation by using a partially inflated mask in a neonatal manikin | Device: Partially inflated mask<br>* Manikin ventilation with a partially inflated mask<br>|
| Active Comparator: Fully inflated mask<br>Participants will be invited to administer positive pressure ventilation by using a fully inflated mask in a neonatal manikin | Device: Fully inflated mask<br>* Manikin ventilation with a fully inflated mask<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Applied forces on the manikin face | The forces applied by the participants to the manikin face will be measured by sensors positioned on the manikin face | 1 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cuff pressure | The pressure inside the mask will be measured during the procedure | 1 minute | 
| Percentage of ventilation time with leak less than 25% around the mask | The mask leak willbe measured by using a respiratory function monitoring during theprocedure | 1 minute |