- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06171035
Use of 3D Printing High-fidelity Craniofacial Manikin to Teach Noninvasive Positive Pressure Ventilation
Use of 3D Printing High-fidelity Airway and Craniofacial Manikin as an Education Tool to Improve Learning Efficiency of Teaching Noninvasive Positive Pressure Ventilation
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ke-Yun Chao, PhD
- Phone Number: +886905301879
- Email: C00152@mail.fjuh.fju.edu.tw
Study Locations
-
-
-
New Taipei City, Taiwan, 24352
- Fu Jen Catholic University Hospital, Fu Jen Catholic University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Student of Fu Jen Catholic University
Exclusion Criteria:
- Refused to participate in the study
Study Plan
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
Sponsor
Investigators
- Principal Investigator: Ke-Yun Chao, PhD, Fu Jen Catholic University Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FJUH111188
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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