Learning Curve of Fiberoptic Intubation Through Supraglottic Airway Device

NCT04482166 | Completed FDA Device

• 1 other identifier: 2006-160-1135
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intubation;Difficult

Keywords

Fiberoptic bronchoscope; Supraglottic airway

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

• 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

• 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

• Number of trials

  From start of each training period to success of endotracheal intubation, not to exceed 10 minutes

Study Arms (1)

Candidates

EXPERIMENTAL

Training of fiberoptic-guided tracheal intubation through supraglottic airway device to pediatric airway manikin

Other: Training; Device: supraglottic airway device

Interventions

Training OTHER

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

Candidates

supraglottic airway device DEVICE

supraglottic airway device

Candidates

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Residents under anesthesiology training with experience of more than 30 times of supraglottic airway device insertion and manipulation of fiberoptic bronchoscope

You may not qualify if:

• Prior experience of fiberoptic-guided tracheal intubation through supraglottic airway device
• Prior experience of training for fiberoptic-guided tracheal intubation through supraglottic airway device

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Other, 03080, South Korea

Location

Related Publications (10)

• 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.

  PMID: 32022437 BACKGROUND

• 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.

  PMID: 31887239 BACKGROUND

• 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.

  PMID: 25684039 BACKGROUND

• 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. No abstract available.

  PMID: 26956516 BACKGROUND

• 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.

  PMID: 21710368 BACKGROUND

• 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.

  PMID: 30908421 BACKGROUND

• 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.

  PMID: 28577552 BACKGROUND

• Orhan-Sungur M, Altun D, Ozkan-Seyhan T, Aygun E, Koltka K, Camci 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.

  PMID: 31583796 BACKGROUND

• 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):1235. doi: 10.3390/jcm8081235.

  PMID: 31426378 BACKGROUND

• Lee JH, Nam S, Jang YE, Kim EH, Kim HS, Kim JT. Clinical performance of Ambu AuraGainTM versus i-gelTM 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.

  PMID: 33329810 BACKGROUND

Study Officials

• Ji-Hyun Lee, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: July 22, 2020
• Study Start: August 17, 2020
• Primary Completion: July 22, 2021
• Study Completion: August 31, 2021
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)