Endobronchial IntubationeKingMathNCT04689269
Learning Curve of Endobronchial Intubation Using Video Laryngoscopes
A study testing The simulated "easy" airway, The simulated "difficult" airway and King Vision Laryngoscope in people with Endobronchial Intubation, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endobronchial Intubation
- What is being tested?
- The simulated "easy" airway, The simulated "difficult" airway and King Vision Laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 21 Jan 2021to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Decline consent to participate.
- No written informed consent.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Imam Abdulrahman Bin Faisal University
Dammam, Eastern Province, 31592
Alaa M Khidr, MD, + 966 50 847 4241, akhedr@iau.edu.sa
Mohamed M El Tahan, MD, +966 56 937 1849, mohamedrefaateltahan@yahoo.com
About this study
Official title: 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
Read the 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.
- Conditions
- Endobronchial Intubation
- Being tested
- The simulated "easy" airway, The simulated "difficult" airway, King Vision Laryngoscope, MacGrath Laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The simulated "easy" airwayOther
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
The simulated "difficult" airwayOther
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 LaryngoscopeDevice
Using a King Vision Laryngoscope for placement of the DLT
MacGrath LaryngoscopeDevice
Using a MacGrath Laryngoscope for placement of the DLT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: The simulated "easy" airway; Other: The simulated "difficult" airway; Device: King Vision Laryngoscope; Device: MacGrath Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 month
Secondary outcomes (9)
Time to endobronchial intubation
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.
Measured: for 180 seconds from the passage of the video laryngoscope through the central incisors
Time to placement of the endobronchial tube
The time to placement of the endobronchial tube in the left main bronchus
Measured: for 360 seconds from the passage of the video laryngoscope through the central incisors
Percentage of glottic opening (POGO) score
The best view during laryngoscopy using the classification described by percentage of glottic opening (POGO) score
Measured: for 180 seconds from the passage of the video laryngoscope through the central incisors
The difficulty of intubation
The difficulty of intubation evaluated using a visual analog scale (VAS) (ranging from 0, meaning extremely easy, to 100, which is extremely difficult).
Measured: for 180 seconds from the passage of the video laryngoscope through the central incisors
The first-pass success
The first-pass success ratio is calculated as the number of first-attempt successes over the number of intubation attempts.
Measured: 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
The number of times the video laryngoscope is withdrawn from mouth then inserted again.
Measured: for 180 seconds from the passage of the video laryngoscope through the central incisors
The number of times optimization maneuvers
The number of times optimization maneuvers are used in each attempt
Measured: for 180 seconds from the passage of the video laryngoscope through the central incisors
The number of required external laryngeal manipulation
The number of required external laryngeal manipulation to improve the glottic view
Measured: for 180 seconds from the passage of the video laryngoscope through the central incisors
The preferred device
The preferred device as rated by the participant after completing all intubation attempts
Measured: For 4 weeks from the start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start21 Jan 2021
- Primary completionMar 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Endobronchial IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alaa M Khidr, MD, Principal investigator, Assistant Professor & Consultant of Anesthesia and Surgical Intensive CareMohamed M El Tahan, MD, Study chair, Professor of Cardiothoracic Anaesthesia & Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689269
- Sponsor's protocol ID
- IRB-PGS-2020-01-390
- Acronym
- eKingMath
- Status last verified
- Jan 2021
- First submitted
- 25 Dec 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The individual participant data (IPD) will be available to other researchers on request for 3 years after completing the study.
Publications
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.
PubMed 24219251Lewis 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.
PubMed 28969318Risse 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.
PubMed 32546128Yao 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.
PubMed 25721326Yoo 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.
PubMed 29517671Bakshi 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.
PubMed 31263297El-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.
PubMed 29056498El-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.
PubMed 27171733Failor 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.
PubMed 24231196Altun 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.
PubMed 30908421
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endobronchial Intubation With the King Vision and McGrath Laryngoscopes in Simulated Easy and Difficult Airways by Novices. (eKingMath)
- ClinicalTrials.gov ID
- NCT04689269
- Acronym / sponsor ID
- eKingMath / IRB-PGS-2020-01-390
- Conditions
- Endobronchial Intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| McGrath-King Vision | Active comparator | Other: The simulated "easy" airway, Other: The simulated "difficult" airway, Device: King Vision Laryngoscope, Device: MacGrath LaryngoscopeThe 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. |
| King Vision-McGrath | Active comparator | Other: The simulated "easy" airway, Other: The simulated "difficult" airway, Device: King Vision Laryngoscope, Device: MacGrath LaryngoscopeThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Decline consent to participate.
- No written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The simulated "easy" airwayA 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 | King Vision-McGrath, McGrath-King Vision |
| The simulated "difficult" airwayA 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. | Other | King Vision-McGrath, McGrath-King Vision |
| King Vision LaryngoscopeUsing a King Vision Laryngoscope for placement of the DLT | Device | King Vision-McGrath, McGrath-King Vision |
| MacGrath LaryngoscopeUsing a MacGrath Laryngoscope for placement of the DLT | Device | King Vision-McGrath, McGrath-King Vision |
Primary outcome
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
9 secondary outcomes
Time to endobronchial intubation
Time frame: 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
Percentage of glottic opening (POGO) score
Time frame: 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 first-pass success
Time frame: 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 optimization maneuvers
Time frame: 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 preferred device
Time frame: For 4 weeks from the start of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Background: PubMed 24219251Russell 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.
- Background: PubMed 28969318Lewis 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.
- Background: PubMed 32546128Risse 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.
- Background: PubMed 25721326Yao 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.
- Background: PubMed 29517671Yoo 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.
- Background: PubMed 31263297Bakshi 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.
- Background: PubMed 29056498El-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.
- Background: PubMed 27171733El-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.
- Background: PubMed 24231196Failor 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.
- Background: PubMed 30908421Altun 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.
- Individual participant dataSharing planned: Yes. The individual participant data (IPD) will be available to other researchers on request for 3 years after completing the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaa M Khidr, MD principal investigator
Assistant Professor & Consultant of Anesthesia and Surgical Intensive Care
Mohamed M El Tahan, MD study chair
Professor of Cardiothoracic Anaesthesia & Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The simulated "easy" airway, The simulated "difficult" airway and King Vision Laryngoscope in people with Endobronchial Intubation, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa M Khidr, MD (+ 966 50 847 4241, akhedr@iau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The learning curve of using the device tested (time frame: through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04689269, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.