Use of 3D Printing High-fidelity Craniofacial Manikin to Teach Noninvasive Positive Pressure Ventilation

January 19, 2024 updated by: Ke-Yun, Chao, Fu Jen Catholic University

Use of 3D Printing High-fidelity Airway and Craniofacial Manikin as an Education Tool to Improve Learning Efficiency of Teaching Noninvasive Positive Pressure Ventilation

The aim of this study is to enhance the learning efficiency and ability of problem-solving for student of Department of Respiratory Therapy with the innovative 3D printing high-fidelity manikin.

Study Overview

Detailed Description

Background :

Noninvasive positive pressure ventilation plays an important role in treatment of respiratory failure. Respiratory Therapists should be familiar with operating ventilator, choosing the adequate interface, and putting the interface on patients' face correctly. Simulation-based clinical training was limited because of lack of the high-fidelity manikins or simulators. To enhance the simulation-based clinical training, the investigators develop 3D printing models and applied into the medical school and hospital training.

Study Design :

The first part is a laboratory in-vitro experiment; the second part is a randomized controlled trial of medical education study.

Methods :

The 3D scanning and 3D printing technology will be using to create the high-fidelity manikin with an upper and lower airway tract. The 3D printing material will be choosing to be able to close real human organ especially considering the soft biological tissue. The present study will be divided into two parts. The first part is a laboratory in-vitro experiment, which aims to verified the function of the high-fidelity manikin; the second part is a medical education study.

Effect :

The investigators expect the use of 3D high-fidelity model in training students of Department of Respiratory Therapy will enhance the learning efficiency and ability of problem-solving.

The experience and outcome of the study will further extent to medical school and hospital training.

Key words:

3D printing; medical education model; high-fidelity simulation; respiratory care.

Study Type

Interventional

Enrollment (Estimated)

50

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 Contact

Study Locations

      • New Taipei City, Taiwan, 24352
        • Fu Jen Catholic University Hospital, Fu Jen Catholic University

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Student of Fu Jen Catholic University

Exclusion Criteria:

  • Refused to participate in the study

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional model group
Received a regular learning
Slide-based presention plus traditional model
Experimental: 3D-printed high-fidelity craniofacial manikin model presention group
Received a regular learning plus 3D printing model
Slide-based presention plus 3D printed model

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examination score of pre-intervention
Time Frame: pre-intervention
score of pre-intervention (maximun 100 and minimum 0), higher means a better outcome.
pre-intervention
Examination score of post-intervention
Time Frame: immediately after the intervention
score of post-intervention (maximun 100 and minimum 0), higher means a better outcome.
immediately after the intervention

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Ke-Yun Chao, PhD, Fu Jen Catholic University Hospital

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 (Estimated)

June 10, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

December 6, 2023

First Submitted That Met QC Criteria

December 6, 2023

First Posted (Actual)

December 14, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

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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