Clinical trial NCT04689269: Learning Curve of Endobronchial Intubation Using Video Laryngoscopes
Official title: Endobronchial Intubation With the King Vision and McGrath Laryngoscopes in Simulated Easy and Difficult Airways by Novices. (eKingMath)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endobronchial Intubation
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: OTHER

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The learning curve of using the device tested
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
measure: Time to endobronchial intubation
timeFrame: for 180 seconds from the passage of the video laryngoscope through the central incisors
measure: Time to placement of the endobronchial tube
timeFrame: for 360 seconds from the passage of the video laryngoscope through the central incisors
measure: Percentage of glottic opening (POGO) score
timeFrame: for 180 seconds from the passage of the video laryngoscope through the central incisors
measure: The difficulty of intubation
timeFrame: for 180 seconds from the passage of the video laryngoscope through the central incisors
measure: The first-pass success
timeFrame: for 360 seconds from the passage of the video laryngoscope through the central incisors
measure: The number of times the video laryngoscope is withdrawn from mouth
timeFrame: for 180 seconds from the passage of the video laryngoscope through the central incisors
measure: The number of times optimization maneuvers
timeFrame: for 180 seconds from the passage of the video laryngoscope through the central incisors
measure: The number of required external laryngeal manipulation
timeFrame: for 180 seconds from the passage of the video laryngoscope through the central incisors
measure: The preferred device
timeFrame: For 4 weeks from the start of study
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: Imam Abdulrahman Bin Faisal University
state: Eastern
Study officials:
affiliation: Assistant Professor & Consultant of Anesthesia and Surgical Intensive Care
name: Alaa M Khidr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Cardiothoracic Anaesthesia & Surgical Intensive Care
name: Mohamed M El Tahan, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.