3D Printed Model Simulator or Virtual Reality Software for Training Fiberoptic Intubation Skill

May 12, 2022 updated by: Panop Limratana, Mahidol University

Fiberoptic Intubation Skill Performance After Self-directed Training Among Anesthesiology Residents: A Randomized Comparison of a 3D-printed Model Simulator and a Virtual Reality Software

Fiberoptic-assisted intubation is an advanced skill that requires learners' practice as well as clinical experience during the anesthesiology residency training period. Current training methods including airway simulators and virtual reality software are used by medical schools worldwide.

The objective of this study is to compare the learner's fiberoptic intubation performance between training with a 3D-printed simulator and a virtual reality software.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fiberoptic-assisted intubation (FOI) is an essential skill of an anesthesiologist. It requires comprehensive knowledge of the airway anatomy and the proper and skillful use of a fiberoptic bronchoscope.

Fiberoptic-assisted intubations are usually performed in emergency situations and during difficult airway patient encounters. These situations are not ideal for learners to properly practice the skill.

The process of acquiring FOI skills includes teaching by experienced instructors, self-practice using commercially-available airway simulators, and practicing on virtual reality software.

The airway simulators and virtual reality software have their advantages and disadvantages.

In this randomized study, the investigators will compare the fiberoptic intubation skill among anesthesiology residents after self-training on a custom-made 3D simulator and self-training on a virtual reality software.

Study Type

Interventional

Enrollment (Actual)

27

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

  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Second-year anesthesiology resident

Exclusion Criteria:

  • Refuse to participate

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D printed simulator

The participants in this arm will undergo two self-directed training sessions on a custom-made 3D-printed airway simulator. The participants will use a standard intubating fiberoptic bronchoscope to practice fiberoptic-assisted nasal intubation.

The sessions will be one week apart. Each session is 30 minutes per participant.
Other: 3D-printed airway simulator
Two self-directed training on a standard fiberoptic bronchoscope and a custom-made 3D airway simulator.
Experimental: Virtual reality software

The participants in this arm will practice fiberoptic-assisted nasal intubation using the free virtual reality software (AirwayEX) on their mobile phones or computer tablets. Two practice sessions are required by the investigators. The sessions will be one week apart. Each session is 30 minutes per participant.

The participants in this arm will have the opportunity to practice on the software as often as they feel necessary. All the additional practice data will be recorded.
Other: virtual reality software, AirwayEx
Two self-directed training on AirwayEx. With additional training as necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global rating scale score for fiberoptic intubation performance (GRS scale)
Time Frame: 1 week after self-directed practice session

The 5-point rating scale assessing multiple aspects of fiberoptic intubation performance.

The assessment includes, on the scale of 1 (minimum score) to 5 (maximum score), the following;

  1. Control
  2. Progression
  3. Orientation
  4. Views and collision
  5. Accuracy
1 week after self-directed practice session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to successful intubation
Time Frame: 1 week after self-directed practice session

The duration measured from the passing of the fiberoptic bronchoscope through the nasal opening and the time of successful intubation (defined as the passing of the endotracheal tube into the trachea above the carina).

The measured duration is reported as seconds.
1 week after self-directed practice session

Collaborators and Investigators

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

Sponsor

Mahidol University

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)

January 15, 2022

Primary Completion (Actual)

April 18, 2022

Study Completion (Actual)

April 18, 2022

Study Registration Dates

First Submitted

November 18, 2021

First Submitted That Met QC Criteria

December 2, 2021

First Posted (Actual)

December 3, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2022

Last Update Submitted That Met QC Criteria

May 12, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 877/2021

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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