Three-dimensional Upper Gastrointestinal Tract Model

Development of 3D Printing High-Fidelity Upper Gastrointestinal Tract Model for Nursing Students in the Nasogastric Tube Training

This study aims to develop an upper body manikin with a high-fidelity upper gastrointestinal tract and apply into the nasogastric tube training program for nursing students.

Study Overview

• Status: Recruiting
• Conditions: Medical Education
• Intervention / Treatment: Other: 3D printed educational model; Other: Traditional model education

Detailed Description

Background：

Nursing trainees often fail to correctly prepare medical supplies and use stethoscopes for position assessment incorrectly when physicians perform nasogastric tube placement techniques. The traditional training model are expensive and difficult to access or maintain. It is easy to cause irreparable damage when repeated tearing and sticking of the elastic adhesive tape on the traditional model. Because of the high-priced the traditional model, it is impossible to use real milk, to simulate the nasogastric tube feeding. Inadequate clinical skills often raises patient safety concerns when assisting in changing nose pads and feeding. To enhance the nasogastric tube training for nursing students, the investigators used 3D-printed education model combined with clinical simulation-based training program.

Study Design：

This is a randomized controlled trial of medical education study.

Methods：

The investigators first designed our 3D upper body model using the 3D processing and analysis software. To create the basic outline of the 3D model, the investigators used a white-light handheld 3D scanner to scan a real human. To closely resemble the soft biological tissues of real human organs, an adequate material will be chosen in the study. The pre/post examination, student satisfaction, and direct observation of procedural skills will be used to evaluation the outcome of the study.

Effect：

The investigators expect the 3D-printed upper body manikin with a high-fidelity upper gastrointestinal tract model has potential in nasogastric tube training, particularly in helping trainees become familiar with the nasogastric tube care.

Keywords：

3D printing, upper body manikin, upper gastrointestinal tract, nasogastric tube care, simulation-based training

• Study Type: Interventional
• Enrollment (Estimated): 60
• 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

• Taiwan
  • New Taipei City, Taiwan, 24352
    • Recruiting
    • Fu Jen Catholic University Hospital, Fu Jen Catholic University
    • Contact: Ke-Yun Chao, PhD; Phone Number: +886-905-301-879; Email: ck_qq@hotmail.com
    • Principal Investigator: Ke-Yun Chao, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Training at Fu Jen Catholic University Hospital.
• Signed the consent form.

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)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D-printed presention group; Received a regular learning plus 3D printing model	Other: 3D printed educational model; Slide-based presention plus 3D printed educational model
Active Comparator: Traditional model group; Received a regular learning	Other: Traditional model education; Slide-based presention plus traditional model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examination score of direct observation of procedural skills	maximun 100 and minimum 0, higher means a better outcome.	immediately after the intervention

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: October 28, 2023
• First Submitted That Met QC Criteria: October 28, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: 3D printing; upper gastrointestinal tract; simulation-based training; upper body manikin; nasogastric tube care
• Other Study ID Numbers: FJUH111192

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