Learning Curve of Endobronchial Intubation Using Video Laryngoscopes

NCT04689269 | Unknown DMC FDA Device

• 1 other identifier: IRB-PGS-2020-01-390
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The use of video laryngoscopes for endobronchial intubation has its own potential benefits particularly in case of airway difficulty. It is not clear how many cases are required to show competency in successful endobronchial intubation using McGrath and King Vision video laryngoscopes in simulated "easy" and "difficult" airways by novices. The here proposed randomized crossover clinical trial will test the learning curve of using each of McGrath and King Vision video laryngoscopes in simulated "easy" and "difficult" airways with respect to the number of intubation trials for successful endobronchial intubation

Conditions

Endobronchial Intubation

Outcome Measures

Primary Outcomes (1)

• The learning curve of using the device tested

  The learning curve will be measured with the successful endobronchial intubation within 180 seconds on simulated "easy" and "difficult" airways using McGrath and King Vision video laryngoscopes by cumulative sum (CUSUM) analysis using an EXCEL Spreadsheet. Performance of the participants will be assessed for the duration of the study until completing 25 intubation attempts on each of the simulated "easy" and "difficult" airway models with a minimum of one day apart from each model. 25 intubation attempts

  through study completion, an average of 1 month

Secondary Outcomes (9)

• Time to endobronchial intubation

  for 180 seconds from the passage of the video laryngoscope through the central incisors

• Time to placement of the endobronchial tube

  for 360 seconds from the passage of the video laryngoscope through the central incisors

• Percentage of glottic opening (POGO) score

  for 180 seconds from the passage of the video laryngoscope through the central incisors

• The difficulty of intubation

  for 180 seconds from the passage of the video laryngoscope through the central incisors

• The first-pass success

  for 360 seconds from the passage of the video laryngoscope through the central incisors

Study Arms (2)

McGrath-King Vision

ACTIVE COMPARATOR

The participants will attempt double-lumen tube intubation using the McGrath (X-blade) laryngoscope then they will use the King Vision (channelled blade size 3) in the same order.

Other: The simulated "easy" airway; Other: The simulated "difficult" airway; Device: King Vision Laryngoscope; Device: MacGrath Laryngoscope

King Vision-McGrath

ACTIVE COMPARATOR

The participants will attempt double-lumen tube intubation using the King Vision (channelled blade size 3) then they will use the McGrath (X-blade) laryngoscope in the same order.

Other: The simulated "easy" airway; Other: The simulated "difficult" airway; Device: King Vision Laryngoscope; Device: MacGrath Laryngoscope

Interventions

The simulated "easy" airway OTHER

A high-fidelity simulator (Airway Management Trainer, model AA-3100, Laerdal Medical Ltd., Orpington, England, UK) will be equipped to create an easy airway situation by adjusting the manikin until it becomes in a neutral position

King Vision-McGrath; McGrath-King Vision

The simulated "difficult" airway OTHER

A high-fidelity simulator (Airway Management Trainer, model AA-3100, Laerdal Medical Ltd., Orpington, England, UK) will be equipped to create a "difficult" airway scenario will be established by placing the occiput on an Oasis Elite™ Prone Head Rest, Adult (140 mm in height) (Covidien, Mansfield, MA, USA), and inhibiting head and neck movement by securing the head with an adhesive tape, simulating the effect produced by a cervical-collar.

King Vision-McGrath; McGrath-King Vision

King Vision Laryngoscope DEVICE

Using a King Vision Laryngoscope for placement of the DLT

King Vision-McGrath; McGrath-King Vision

MacGrath Laryngoscope DEVICE

Using a MacGrath Laryngoscope for placement of the DLT

King Vision-McGrath; McGrath-King Vision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Novice medical school students in using the devices tested.
• Are not familiar with double-lumen tube (DLT) insertion.
• Having no previous experience with the two tested video laryngoscopes for tracheal intubation.

You may not qualify if:

• Decline consent to participate.
• No written informed consent.

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

Imam Abdulrahman Bin Faisal University

Dammam, Eastern Province, 31592, Saudi Arabia

RECRUITING

Related Publications (10)

• Russell T, Slinger P, Roscoe A, McRae K, Van Rensburg A. A randomised controlled trial comparing the GlideScope((R)) and the Macintosh laryngoscope for double-lumen endobronchial intubation. Anaesthesia. 2013 Dec;68(12):1253-8. doi: 10.1111/anae.12322.

  PMID: 24219251 BACKGROUND

• Lewis SR, Butler AR, Parker J, Cook TM, Schofield-Robinson OJ, Smith AF. Videolaryngoscopy versus direct laryngoscopy for adult patients requiring tracheal intubation: a Cochrane Systematic Review. Br J Anaesth. 2017 Sep 1;119(3):369-383. doi: 10.1093/bja/aex228.

  PMID: 28969318 BACKGROUND

• Risse J, Schubert AK, Wiesmann T, Huelshoff A, Stay D, Zentgraf M, Kirschbaum A, Wulf H, Feldmann C, Meggiolaro KM. Videolaryngoscopy versus direct laryngoscopy for double-lumen endotracheal tube intubation in thoracic surgery - a randomised controlled clinical trial. BMC Anesthesiol. 2020 Jun 16;20(1):150. doi: 10.1186/s12871-020-01067-x.

  PMID: 32546128 BACKGROUND

• Yao WL, Wan L, Xu H, Qian W, Wang XR, Tian YK, Zhang CH. A comparison of the McGrath(R) Series 5 videolaryngoscope and Macintosh laryngoscope for double-lumen tracheal tube placement in patients with a good glottic view at direct laryngoscopy. Anaesthesia. 2015 Jul;70(7):810-7. doi: 10.1111/anae.13040. Epub 2015 Feb 27.

  PMID: 25721326 BACKGROUND

• Yoo JY, Park SY, Kim JY, Kim M, Haam SJ, Kim DH. Comparison of the McGrath videolaryngoscope and the Macintosh laryngoscope for double lumen endobronchial tube intubation in patients with manual in-line stabilization: A randomized controlled trial. Medicine (Baltimore). 2018 Mar;97(10):e0081. doi: 10.1097/MD.0000000000010081.

  PMID: 29517671 BACKGROUND

• Bakshi SG, Gawri A, Divatia JV. McGrath MAC video laryngoscope versus direct laryngoscopy for the placement of double-lumen tubes: A randomised control trial. Indian J Anaesth. 2019 Jun;63(6):456-461. doi: 10.4103/ija.IJA_48_19.

  PMID: 31263297 BACKGROUND

• El-Tahan MR, Khidr AM, Gaarour IS, Alshadwi SA, Alghamdi TM, Al'ghamdi A. A Comparison of 3 Videolaryngoscopes for Double-Lumen Tube Intubation in Humans by Users With Mixed Experience: A Randomized Controlled Study. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):277-286. doi: 10.1053/j.jvca.2017.08.009. Epub 2017 Aug 4.

  PMID: 29056498 BACKGROUND

• El-Tahan MR, Al'ghamdi AA, Khidr AM, Gaarour IS. Comparison of three videolaryngoscopes for double-lumen tubes intubation in simulated easy and difficult airways: a randomized trial. Minerva Anestesiol. 2016 Oct;82(10):1050-1058. Epub 2016 May 12.

  PMID: 27171733 BACKGROUND

• Failor E, Bowdle A, Jelacic S, Togashi K. High-fidelity simulation of lung isolation with double-lumen endotracheal tubes and bronchial blockers in anesthesiology resident training. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):865-9. doi: 10.1053/j.jvca.2013.07.015. Epub 2013 Nov 12.

  PMID: 24231196 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

Study Officials

• Alaa M Khidr, MD

  Assistant Professor & Consultant of Anesthesia and Surgical Intensive Care

  PRINCIPAL INVESTIGATOR

• Mohamed M El Tahan, MD

  Professor of Cardiothoracic Anaesthesia & Surgical Intensive Care

  STUDY CHAIR

Central Study Contacts

Alaa M Khidr, MD

CONTACT

+ 966 50 847 4241; akhedr@iau.edu.sa

Mohamed R El Tahan, MD

CONTACT

+966 56 937 1849; mohamedrefaateltahan@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blind to the data collected
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-center, interventional, crossover, single-blind (participant), prospective, trial in simulated "easy" and "difficult" airway. The study will be conducted according to Good Clinical Practice (GCP) Guidelines and abide by the principles of the Declaration of Helsinki.

Study Record Dates

• First Submitted: December 25, 2020
• First Posted: December 30, 2020
• Study Start: January 21, 2021
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: for 3 years after completing the study.
• Access Criteria: Upon an official request sent to the principal investigator.

Locations

SA (1)