NCT05143606

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2022

Completed
Last Updated

May 13, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

November 18, 2021

Last Update Submit

May 12, 2022

Conditions

Keywords

Fiberoptic bronchoscopyintubation skilldeliberate practice

Outcome Measures

Primary Outcomes (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

    1 week after self-directed practice session

Secondary Outcomes (1)

  • Time to successful intubation

    1 week after self-directed practice session

Study Arms (2)

3D printed simulator

EXPERIMENTAL

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

Virtual reality software

EXPERIMENTAL

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

Interventions

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

3D printed simulator

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

Virtual reality software

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Second-year anesthesiology resident

You may not qualify if:

  • Refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Related Publications (12)

  • 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.

    PMID: 23364566BACKGROUND
  • Wiles MD, McCahon RA, Armstrong JAM. An Audit of Fibreoptic Intubation Training Opportunities in a UK Teaching Hospital. Journal of Anesthesiology. 2014;703820.

    BACKGROUND
  • 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.

    PMID: 18714618BACKGROUND
  • 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.

    PMID: 11506104BACKGROUND
  • 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.

    PMID: 28127746BACKGROUND
  • 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.

    PMID: 32536185BACKGROUND
  • 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.

    PMID: 29621098BACKGROUND
  • 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.

    PMID: 22310190BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 31248397BACKGROUND
  • 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.

    PMID: 26099760BACKGROUND
  • 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.

    PMID: 26493397BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessors are blinded to each participant's group allocation. The assessors will be provided with video clips of the participants performing FOI. The identity and group allocation of each participant will not be revealed during the assessment.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 18, 2021

First Posted

December 3, 2021

Study Start

January 15, 2022

Primary Completion

April 18, 2022

Study Completion

April 18, 2022

Last Updated

May 13, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations