Resuscitation Table Height for Face-mask Ventilation in Infants (ForTab)

April 4, 2024 updated by: Daniele Trevisanuto, University Hospital Padova

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

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
      • Padova, Italy, 35128
        • Azienda Ospedaliera di Padova, University of 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Level III neonatal intensive neonatal care unit consultants and pediatric residents

Exclusion Criteria:

  • None

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: High resuscitation table
Participants will be invited to administer face-mask ventilation setting the table height to the operator's xiphoid process in a neonatal manikin.
Other: High resuscitation table
Participants will be invited to administer face-mask ventilation setting the table height to the operator's xiphoid process in a neonatal manikin.
Active Comparator: Low resuscitation table
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.
Other: Low resuscitation table
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 minute after initiation of ventilation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cuff pressure
Time Frame: 1 minute after initiation of ventilation
The pressure inside the mask will be measured during the procedure
1 minute after initiation of ventilation
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
1 minute after initiation of ventilation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 minutes after the end of the procedure

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)

February 12, 2024

Primary Completion (Actual)

February 15, 2024

Study Completion (Actual)

February 15, 2024

Study Registration Dates

First Submitted

December 1, 2023

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEOUNIPD4(2023)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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