Learning Curve of Endobronchial Intubation Using Video Laryngoscopes (eKingMath)

January 24, 2021 updated by: Imam Abdulrahman Bin Faisal University

Endobronchial Intubation With the King Vision and McGrath Laryngoscopes in Simulated Easy and Difficult Airways by Novices. (eKingMath)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Surgeries that require lung isolation have been using double-lumen tubes (DLT) for endobronchial intubation as the preferred method due to its numerous advantages.

However, the larger diameter of the DLT compared to the single-lumen tube can be more difficult to insert during intubation. [1] The use of video laryngoscopes (VL), which were found to have lower rates of intubation failure, reduced incidences of tracheal and laryngeal trauma, improved glottic view, and increased ease of use, are gaining interest for its use in endobronchial intubation. [2, 3]

The use of McGrath® VL systems for DLT endobronchial intubation has been studied and compared to that of conventional laryngoscopy, as well as that of other VL systems. When compared to the conventional Macintosh laryngoscope, McGrath® VL has been consistently associated with a better glottic visualization. [4 - 6] Other advantages include reduced need for external laryngeal manipulation and a lower rate of intubation-associated complications, such as bronchospasm and trauma to the oral mucosa. [7] However, results regarding time to intubation have been controversial.

The use of King Vision® VL for DLT endobronchial intubation has not been studied as much as the McGrath® video laryngoscope. Two studies compared the King Vision® VL system to the conventional Macintosh laryngoscope and to other VL systems. When comparing King Vision® to Macintosh laryngoscope, the time to intubation was comparable between the two devices. [8, 9] However, one study found that in a simulated easy airway, a significantly longer time to intubation was shown with King Vision® VL. [9] King Vision® VL and Macintosh laryngoscope were also comparable in terms of glottic visualization, intubation difficulty, first-pass success rates, need for optimizing maneuvers, and postoperative symptoms indicative of pharyngeal or laryngeal trauma. [8, 9]

Therefore, competency in endobronchial intubation using video aided laryngoscopes is built through continuous and regular hands-on training. [10] The learning curve of the novice is usually monitored aiming to detect when satisfactory performances are reached. This is widely done using the cumulative sum analysis (CUSUM) test, which provides an objective evaluating method of skill learning via ongoing monitoring. [11]

  • Educational Course.

    • All participants will attend a 30-minutes didactic virtual training course on the Zoom platform equipped with a slide presentation including a demonstrative video on the endobronchial intubation and the tips and tricks for using the two study devices.
    • Additionally, a 5-minute hands-on practice session would be provided on each simulated airway model under close supervision by the investigators (AK, MK, SS, and TAG).
  • Before each DLT intubation attempt, the manikin, laryngoscope blade, and DLT will be lubricated.
  • After completing the DLT intubation, participants should have a 15-minute break before performing intubation using another laryngoscope.
  • All intubations will be performed with a 35-Fr left-side DLT.
  • The participants will not be allowed to watch each other to avoid any learning effect through observation.

DATA ANALYSIS

Updated and finalized statistical analysis plan will be written, before closing the database.

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Saudi Arabia
    • Eastern
      • Dammam, Eastern, Saudi Arabia, 31592
        • Recruiting
        • Imam Abdulrahman Bin Faisal University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Aziza R Bokhari, Medical student
        • Sub-Investigator:
          • Jumana H Masoudi, Medical student
        • Sub-Investigator:
          • Mashael S Alshahrani, Medical student
        • Sub-Investigator:
          • Sarah W AlAboud, Medical student
        • Sub-Investigator:
          • Mohamed A Khalil, MD
        • Sub-Investigator:
          • Saeed Al Shadowy, MD
        • Sub-Investigator:
          • Talal Al Ghamdi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: McGrath-King Vision
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
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
Other: The simulated "difficult" airway
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.
Device: King Vision Laryngoscope
Using a King Vision Laryngoscope for placement of the DLT
Device: MacGrath Laryngoscope
Using a MacGrath Laryngoscope for placement of the DLT
Active Comparator: King Vision-McGrath
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
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
Other: The simulated "difficult" airway
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.
Device: King Vision Laryngoscope
Using a King Vision Laryngoscope for placement of the DLT
Device: MacGrath Laryngoscope
Using a MacGrath Laryngoscope for placement of the DLT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The learning curve of using the device tested
Time Frame: through study completion, an average of 1 month

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to endobronchial intubation
Time Frame: for 180 seconds from the passage of the video laryngoscope through the central incisors
The time needed to achieve endobronchial intubation, which starts from the passage of the video laryngoscope through the central incisors to when the tip of the bronchial lumen passes through the glottis, as confirmed by the investigator through the display screens.
for 180 seconds from the passage of the video laryngoscope through the central incisors
Time to placement of the endobronchial tube
Time Frame: for 360 seconds from the passage of the video laryngoscope through the central incisors
The time to placement of the endobronchial tube in the left main bronchus
for 360 seconds from the passage of the video laryngoscope through the central incisors
Percentage of glottic opening (POGO) score
Time Frame: for 180 seconds from the passage of the video laryngoscope through the central incisors
The best view during laryngoscopy using the classification described by percentage of glottic opening (POGO) score
for 180 seconds from the passage of the video laryngoscope through the central incisors
The difficulty of intubation
Time Frame: for 180 seconds from the passage of the video laryngoscope through the central incisors
The difficulty of intubation evaluated using a visual analog scale (VAS) (ranging from 0, meaning extremely easy, to 100, which is extremely difficult).
for 180 seconds from the passage of the video laryngoscope through the central incisors
The first-pass success
Time Frame: for 360 seconds from the passage of the video laryngoscope through the central incisors
The first-pass success ratio is calculated as the number of first-attempt successes over the number of intubation attempts.
for 360 seconds from the passage of the video laryngoscope through the central incisors
The number of times the video laryngoscope is withdrawn from mouth
Time Frame: for 180 seconds from the passage of the video laryngoscope through the central incisors
The number of times the video laryngoscope is withdrawn from mouth then inserted again.
for 180 seconds from the passage of the video laryngoscope through the central incisors
The number of times optimization maneuvers
Time Frame: for 180 seconds from the passage of the video laryngoscope through the central incisors
The number of times optimization maneuvers are used in each attempt
for 180 seconds from the passage of the video laryngoscope through the central incisors
The number of required external laryngeal manipulation
Time Frame: for 180 seconds from the passage of the video laryngoscope through the central incisors
The number of required external laryngeal manipulation to improve the glottic view
for 180 seconds from the passage of the video laryngoscope through the central incisors
The preferred device
Time Frame: For 4 weeks from the start of study
The preferred device as rated by the participant after completing all intubation attempts
For 4 weeks from the start of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imam Abdulrahman Bin Faisal University

Investigators

  • Principal Investigator: Alaa M Khidr, MD, Assistant Professor & Consultant of Anesthesia and Surgical Intensive Care
  • Study Chair: Mohamed M El Tahan, MD, Professor of Cardiothoracic Anaesthesia & Surgical Intensive Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2021

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

December 25, 2020

First Submitted That Met QC Criteria

December 29, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 24, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • IRB-PGS-2020-01-390

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The individual participant data (IPD) will be available to other researchers on request for 3 years after completing the study.

IPD Sharing Time Frame

for 3 years after completing the study.

IPD Sharing Access Criteria

Upon an official request sent to the principal investigator.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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