Learning Curve of Fiberoptic Intubation Through Supraglottic Airway Device

Intubation;Difficult Clinical Trial

Official title:

Learning Curve of Fiberoptic-guided Tracheal Intubation Through Supraglottic Airway Device for Pediatric Difficult Airway Manikin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04482166
• Other study ID #: 2006-160-1135
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Intubation;Difficult

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