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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04482166
Other study ID # 2006-160-1135
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 17, 2020
Est. completion date August 31, 2021

Study information

Verified date September 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to obtain learning curve data of residents for fiberoptic-guided tracheal intubation through supraglottic airway device for pediatric difficult airway manikin.


Description:

Residents under anesthesiology training will undergo a simulation practice to a pediatric airway manikin, after a single demonstration by an expert for fiberoptic-guided tracheal intubation through supraglottic airway device. The participants will do the same practice 20 times to the same manikin.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 31, 2021
Est. primary completion date July 22, 2021
Accepts healthy volunteers No
Gender All
Age group 25 Years to 40 Years
Eligibility Inclusion Criteria: - Residents under anesthesiology training with experience of more than 30 times of supraglottic airway device insertion and manipulation of fiberoptic bronchoscope Exclusion Criteria: - Prior experience of fiberoptic-guided tracheal intubation through supraglottic airway device - Prior experience of training for fiberoptic-guided tracheal intubation through supraglottic airway device

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Training
20-times training of fiberoptic-guided tracheal intubation through supraglottic airway device to pediatric airway manikin
Device:
supraglottic airway device
supraglottic airway device

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul Other

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (10)

Altun D, Ozkan-Seyhan T, Camci E, Sivrikoz N, Orhan-Sungur M. Learning Curves for Two Fiberscopes in Simulated Difficult Airway Scenario With Cumulative Sum Method. Simul Healthc. 2019 Jun;14(3):163-168. doi: 10.1097/SIH.0000000000000368. — View Citation

Black AE, Flynn PE, Smith HL, Thomas ML, Wilkinson KA; Association of Pediatric Anaesthetists of Great Britain and Ireland. Development of a guideline for the management of the unanticipated difficult airway in pediatric practice. Paediatr Anaesth. 2015 Apr;25(4):346-62. doi: 10.1111/pan.12615. Epub 2015 Feb 16. — View Citation

Dalal PG, Dalal GB, Pott L, Bezinover D, Prozesky J, Bosseau Murray W. Learning curves of novice anesthesiology residents performing simulated fibreoptic upper airway endoscopy. Can J Anaesth. 2011 Sep;58(9):802-9. doi: 10.1007/s12630-011-9542-2. Epub 2011 Jun 28. — View Citation

Hunyady A, Polaner D. Pediatric airway management education and training. Paediatr Anaesth. 2020 Mar;30(3):362-370. doi: 10.1111/pan.13808. Epub 2020 Jan 16. Review. — View Citation

Kim HJ, Park HS, Kim SY, Ro YJ, Yang HS, Koh WU. A Randomized Controlled Trial Comparing Ambu AuraGain and i-gel in Young Pediatric Patients. J Clin Med. 2019 Aug 16;8(8). pii: E1235. doi: 10.3390/jcm8081235. — View Citation

Kovatsis PG. Continuous ventilation during flexible fiberscopic-assisted intubation via supraglottic airways. Paediatr Anaesth. 2016 Apr;26(4):457-8. doi: 10.1111/pan.12863. — View Citation

Lee JH, Nam S, Jang YE, Kim EH, Kim HS, Kim JT. Clinical performance of Ambu AuraGain(TM) versus i-gel(TM) in anesthetized children: a prospective, randomized controlled trial. Anesth Pain Med (Seoul). 2020 Apr 30;15(2):173-180. doi: 10.17085/apm.2020.15.2.173. Epub 2020 Apr 29. — View Citation

Oliveira KF, Arzola C, Ye XY, Clivatti J, Siddiqui N, You-Ten KE. Determining the amount of training needed for competency of anesthesia trainees in ultrasonographic identification of the cricothyroid membrane. BMC Anesthesiol. 2017 Jun 2;17(1):74. doi: 10.1186/s12871-017-0366-7. — View Citation

Orhan-Sungur M, Altun D, Özkan-Seyhan T, Aygün E, Koltka K, Çamci E. Learning curve of ultrasound measurement of subglottic diameter for endotracheal tube selection in pediatric patients. Paediatr Anaesth. 2019 Dec;29(12):1194-1200. doi: 10.1111/pan.13751. Epub 2019 Oct 20. — View Citation

Stein ML, Park RS, Kovatsis PG. Emerging trends, techniques, and equipment for airway management in pediatric patients. Paediatr Anaesth. 2020 Mar;30(3):269-279. doi: 10.1111/pan.13814. Epub 2020 Feb 5. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Elapsed time to succeed endotracheal intubation for each training period From start of each training period to success of endotracheal intubation, not to exceed 10 minutes
Secondary Elapsed time to successful insertion of supraglottic airway device and ventilation of the manikin for each training period From start of each training period to success of ventilation, not to exceed 10 minutes
Secondary Elapsed time to identification of vocal cords via fiberoptic bronchoscope for each training period From start of each training period to identification of vocal cords, not to exceed 10 minutes
Secondary Elapsed time to introduction of fiberoptic bronchoscope into the trachea for each training period From start of each training period to introduction of fiberoptic bronchoscope into the trachea, not to exceed 10 minutes
Secondary Success rate of endotracheal intubation for each training period From start of each training period to success of endotracheal intubation, not to exceed 10 minutes
Secondary Number of trials Number of trials to succeed ventilation, vocal cord identification, fiberoptic bronchoscope introduction, endotracheal intubation for each training period From start of each training period to success of endotracheal intubation, not to exceed 10 minutes
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