Satisfaction, PersonalNCT05597514
Three-dimensional Airway Suction Model
A study testing 3D printed educational model and Tranditional model education in people with Satisfaction, Personal, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
The main purpose of this study is to use 3D printing technology to high-fidelity simulation respiratory models Furthermore, the results of this study will extent to medical school and hospital. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Satisfaction, Personal
- What is being tested?
- 3D printed educational model and Tranditional model education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Feb 2023to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Student of Fu Jen Catholic University.
Who cannot join
- Refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352
About this study
Official title: The Application of Three-dimensional Printing High-fidelity Simulation Respiratory Models in Airway Suction and Advanced Mechanical Ventilation
The main purpose of this study is to use 3D printing technology to high-fidelity simulation respiratory models Furthermore, the results of this study will extent to medical school and hospital.
Read the detailed description
Background:
Most clinical teaching materials are expensive and inaccessible. To promote the accessibility of anatomy models and student learning effects in our medical school and hospital, we use 3D printing technology to print high-fidelity simulation respiratory models and apply them in medical education.
Study Design:
This is a single-site prospective study of medical education. Participants who are students of the School of respiratory therapy will be randomly divided into to control group and experimental group. Both groups will receive the same teaching program. The traditional education model will be used in the control group, and the 3D printed model will be used in the experimental group.
Methods:
The 3D scanning technology will be applied to create drawing files of high-fidelity simulation respiratory models, which are drawn by professional 3D drawing staff. Then, we print out the models with 3D printing technology. The output material will be close to the softness of the human models. The medical education of this study will be divided into two parts. The first part is the teaching of realistic airway suction; the second part is the simulation of advanced mechanical ventilation.
Effect:
We expect benefits that the use of 3D printing high-fidelity simulation respiratory models in medical education. For example, it can reduce the cost of education models and enhance efficacy in medical education. The experience and outcome will be shared with the medical school and hospital.
Keywords:
3D printing; medical education model; high-fidelity simulation; respiratory care.
- Conditions
- Satisfaction, Personal
- Being tested
- 3D printed educational model, Tranditional model education
- Keywords
- 3D printed, airway suction, respiratory therapy, medical education
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed educational modelOther
Slide-based presention plus 3D printed airway suction model
Tranditional model educationOther
Slide-based presention plus tranditional model
| Study group | Role | What they receive |
|---|---|---|
| Tranditional model group | Active comparator | Received a regular learning Receives: Other: Tranditional model education |
| 3D-printed presention group | Experimental | Received a regular learning plus 3D printing model Receives: Other: 3D printed educational model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examination score of pre-intervention
score of pre-intervention (maximun 100 and minimum 0), higher means a better outcome.
Measured: pre-intervention
Examination score of post-intervention
score of post-intervention (maximun 100 and minimum 0), higher means a better outcome.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start22 Feb 2023
- Primary completion8 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satisfaction, PersonalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke-Yun, Chao, Fu Jen Catholic University
- Investigators
- Ke-Yun Chao, PhD, Principal investigator, Fu Jen Catholic University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597514
- Sponsor's protocol ID
- FJUH110116
- Status last verified
- Feb 2023
- First submitted
- 25 Oct 2022
- Last updated
- 10 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Three-dimensional Printing High-fidelity Simulation Respiratory Models in Airway Suction and Advanced Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05597514
- Acronym / sponsor ID
- FJUH110116
- Conditions
- Satisfaction, Personal
- Keywords
- 3D printed, airway suction, respiratory therapy, medical education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to use 3D printing technology to high-fidelity simulation respiratory models Furthermore, the results of this study will extent to medical school and hospital.
Detailed description
Background:
Most clinical teaching materials are expensive and inaccessible. To promote the accessibility of anatomy models and student learning effects in our medical school and hospital, we use 3D printing technology to print high-fidelity simulation respiratory models and apply them in medical education.
Study Design:
This is a single-site prospective study of medical education. Participants who are students of the School of respiratory therapy will be randomly divided into to control group and experimental group. Both groups will receive the same teaching program. The traditional education model will be used in the control group, and the 3D printed model will be used in the experimental group.
Methods:
The 3D scanning technology will be applied to create drawing files of high-fidelity simulation respiratory models, which are drawn by professional 3D drawing staff. Then, we print out the models with 3D printing technology. The output material will be close to the softness of the human models. The medical education of this study will be divided into two parts. The first part is the teaching of realistic airway suction; the second part is the simulation of advanced mechanical ventilation.
Effect:
We expect benefits that the use of 3D printing high-fidelity simulation respiratory models in medical education. For example, it can reduce the cost of education models and enhance efficacy in medical education. The experience and outcome will be shared with the medical school and hospital.
Keywords:
3D printing; medical education model; high-fidelity simulation; respiratory care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranditional model group | Active comparator | Other: Tranditional model educationReceived a regular learning |
| 3D-printed presention group | Experimental | Other: 3D printed educational modelReceived a regular learning plus 3D printing model |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Student of Fu Jen Catholic University.
Key exclusion criteria (1 listed)
- Refused to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D printed educational modelSlide-based presention plus 3D printed airway suction model | Other | 3D-printed presention group |
| Tranditional model educationSlide-based presention plus tranditional model | Other | Tranditional model group |
Primary outcome
Examination score of pre-intervention
Time frame: pre-intervention
score of pre-intervention (maximun 100 and minimum 0), higher means a better outcome.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ke-Yun Chao, PhD principal investigator
Fu Jen Catholic University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed educational model and Tranditional model education in people with Satisfaction, Personal, run by Fu Jen Catholic University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examination score of pre-intervention (time frame: pre-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.