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Intubation, EndotrachealNCT05143606

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

A study testing 3D-printed airway simulator and virtual reality software, AirwayEx in people with Intubation, Endotracheal, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Intubation, Endotracheal
What is being tested?
3D-printed airway simulator and virtual reality software, AirwayEx
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteThailand
Study dates
15 Jan 2022to 18 Apr 2022
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Second-year anesthesiology resident

Who cannot join

  • Refuse to participate

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Siriraj Hospital

    Bangkok, 10700

Other trials in Thailand

About this study

Official title: 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.

Read the 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.

Being tested
3D-printed airway simulator, virtual reality software, AirwayEx
Keywords
Fiberoptic bronchoscopy, intubation skill, deliberate practice

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D-printed airway simulatorOther

    Two self-directed training on a standard fiberoptic bronchoscope and a custom-made 3D airway simulator.

  • virtual reality software, AirwayExOther

    Two self-directed training on AirwayEx. With additional training as necessary.

Study groups in NCT05143606
Study groupRoleWhat they receive
3D printed simulatorExperimentalThe 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.
Receives: Other: 3D-printed airway simulator
Virtual reality softwareExperimentalThe 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.
Receives: Other: virtual reality software, AirwayEx

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global rating scale score for fiberoptic intubation performance (GRS scale)

    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

    Measured: 1 week after self-directed practice session

Secondary outcomes (1)

  1. Time to successful intubation

    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.

    Measured: 1 week after self-directed practice session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2021
  2. Study start15 Jan 2022
  3. Primary completion18 Apr 2022
  4. Study completion18 Apr 2022

Resources

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
Outcomes assessor
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05143606
Sponsor's protocol ID
877/2021
Status last verified
May 2022
First submitted
18 Nov 2021
Last updated
13 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.

    PubMed 23364566

  • Wiles MD, McCahon RA, Armstrong JAM. An Audit of Fibreoptic Intubation Training Opportunities in a UK Teaching Hospital. Journal of Anesthesiology. 2014;703820.

  • Clarke RC, Gardner AI. Anaesthesia trainees' exposure to airway management in an Australian tertiary adult teaching hospital. Anaesth Intensive Care. 2008 Jul;36(4):513-5.

    PubMed 18714618

  • Naik VN, Matsumoto ED, Houston PL, Hamstra SJ, Yeung RY, Mallon JS, Martire TM. Fiberoptic orotracheal intubation on anesthetized patients: do manipulation skills learned on a simple model transfer into the operating room? Anesthesiology. 2001 Aug;95(2):343-8. doi: 10.1097/00000542-200108000-00014.

    PubMed 11506104

  • Chao I, Young J, Coles-Black J, Chuen J, Weinberg L, Rachbuch C. The application of three-dimensional printing technology in anaesthesia: a systematic review. Anaesthesia. 2017 May;72(5):641-650. doi: 10.1111/anae.13812. Epub 2017 Jan 27.

    PubMed 28127746

  • Carter JC, Broadbent J, Murphy EC, Guy B, Baguley KE, Young J. A three-dimensional (3D) printed paediatric trachea for airway management training. Anaesth Intensive Care. 2020 May;48(3):243-245. doi: 10.1177/0310057X20925827. Epub 2020 Jun 14.

    PubMed 32536185

  • Jiang B, Ju H, Zhao Y, Yao L, Feng Y. Comparison of the Efficacy and Efficiency of the Use of Virtual Reality Simulation With High-Fidelity Mannequins for Simulation-Based Training of Fiberoptic Bronchoscope Manipulation. Simul Healthc. 2018 Apr;13(2):83-87. doi: 10.1097/SIH.0000000000000299.

    PubMed 29621098

  • Giglioli S, Boet S, De Gaudio AR, Linden M, Schaeffer R, Bould MD, Diemunsch P. Self-directed deliberate practice with virtual fiberoptic intubation improves initial skills for anesthesia residents. Minerva Anestesiol. 2012 Apr;78(4):456-61. Epub 2012 Feb 6.

    PubMed 22310190

  • Kadys A, Rancevienė D, Macas A. Using Smartphone Application iLarynx to Teach Novices to Perform Fiber Optic Intubation. Nursing education, research, & practice: NERP. Kaunas: Lietuvos sveikatos mokslų universitetas, 2016, vol. 6, no. 1. 2016.

  • Ho BHK, Chen CJ, Tan GJS, Yeong WY, Tan HKJ, Lim AYH, Ferenczi MA, Mogali SR. Multi-material three dimensional printed models for simulation of bronchoscopy. BMC Med Educ. 2019 Jun 27;19(1):236. doi: 10.1186/s12909-019-1677-9.

    PubMed 31248397

  • Chan JK, Ng I, Ang JP, Koh SM, Lee K, Mezzavia P, Morris J, Loh F, Segal R. Randomised controlled trial comparing the Ambu(R) aScope2 with a conventional fibreoptic bronchoscope in orotracheal intubation of anaesthetised adult patients. Anaesth Intensive Care. 2015 Jul;43(4):479-84. doi: 10.1177/0310057X1504300410.

    PubMed 26099760

  • K Latif R, Bautista A, Duan X, Neamtu A, Wu D, Wadhwa A, Akca O. Teaching basic fiberoptic intubation skills in a simulator: initial learning and skills decay. J Anesth. 2016 Feb;30(1):12-9. doi: 10.1007/s00540-015-2091-z. Epub 2015 Oct 22.

    PubMed 26493397

Questions about this trial

What is this clinical trial studying?

A study testing 3D-printed airway simulator and virtual reality software, AirwayEx in people with Intubation, Endotracheal, run by Mahidol University at 1 site in Thailand.

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 13 May 2022. 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 Thailand. 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?

Global rating scale score for fiberoptic intubation performance (GRS scale) (time frame: 1 week after self-directed practice session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05143606, which also lists 12 linked publications.

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 13 May 2022.

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