Applied Forces During Neonatal Ventilation With Different Face Masks

November 17, 2025 updated by: Daniele Trevisanuto, University Hospital Padova

Applied Forces During Neonatal Ventilation With Different Face Masks: a Randomized Crossover Manikin Study.

This trial compares the applied forces exerted on the face of a modified preterm neonatal manikin with three different face masks. Additionally, percentages of ventilation time with mask leak <25%, and participants' opinion about perceived applied forces, difficulty in achieving an effective ventilation, and difficulty in obtaining a good mask seal are investigated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Padua, Italy, 35128
        • Azienda Ospedaliera Universita di Padova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Level III neonatal intensive care unit (NICU) consultants, pediatric residents and anesthesiology residents

Exclusion Criteria:

  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anatomical face mask 1
Device: Anatomical face mask 1
Providing face mask ventilation in a neonatal manikin using a model of anatomical face mask
Active Comparator: Anatomical face mask 2
Device: Anatomical face mask 2
Providing face mask ventilation in a neonatal manikin using another model of anatomical face mask
Active Comparator: Round face mask
Device: Round face mask
Providing face mask ventilation in a neonatal manikin using a model of round face mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Applied forces
Time Frame: 1 minute
The force applied on the manikin head by the operator during the procedure
1 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mask leak
Time Frame: 1 minute
Mask leak (measured as percentage of ventilation time with leak less than 25% around the mask)
1 minute
Participant opinion
Time Frame: 2 minutes
Participants' opinions on the face masks (assessed using a Likert scale, from 1 lowest grade to 5 highest grade)
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Padova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Actual)

September 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

September 2, 2025

First Submitted That Met QC Criteria

September 2, 2025

First Posted (Estimated)

September 9, 2025

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • UNIPDNewborn25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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