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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05143606
Other study ID # 877/2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2022
Est. completion date April 18, 2022

Study information

Verified date May 2022
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date April 18, 2022
Est. primary completion date April 18, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Second-year anesthesiology resident Exclusion Criteria: - Refuse to participate

Study Design


Related Conditions & MeSH terms


Intervention

Other:
3D-printed airway simulator
Two self-directed training on a standard fiberoptic bronchoscope and a custom-made 3D airway simulator.
virtual reality software, AirwayEx
Two self-directed training on AirwayEx. With additional training as necessary.

Locations

Country Name City State
Thailand Siriraj Hospital Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & 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. — View Citation

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. — View Citation

Chan JK, Ng I, Ang JP, Koh SM, Lee K, Mezzavia P, Morris J, Loh F, Segal R. Randomised controlled trial comparing the Ambu® aScopeā„¢2 with a conventional fibreoptic bronchoscope in orotracheal intubation of anaesthetised adult patients. Anaesth Intensive Care. 2015 Jul;43(4):479-84. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

K Latif R, Bautista A, Duan X, Neamtu A, Wu D, Wadhwa A, Akça 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. — View Citation

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

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. — View Citation

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

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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;
Control
Progression
Orientation
Views and collision
Accuracy
1 week after self-directed practice session
Secondary 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.
1 week after self-directed practice session
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