Self-Assembled Modified Macintosh Videolaryngoscope Versus McGrath Macintosh (MAC®) Videolaryngoscope: Which is Better?
NCT ID: NCT04850976
Last Updated: 2021-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2020-06-01
2020-08-31
Brief Summary
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The. investigators aim to study a more economical alternative by comparing the intubation time, first attempt success rate, laryngeal visualization, complications, and user satisfaction between our self-assembled modified macintosh videolaryngoscope (SAM-VL) and McGrath MAC® (McGrath).
The study shows that endotracheal intubation using self-assembled modified videolaryngoscope is faster, had more successful first attempts, and allowed better glottis visualization compared with McGrath MAC®. It is a suitable alternative for videolaryngoscope in low resource setting.
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Detailed Description
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Settings and Design: This was a single-blind randomized clinical trial with 62 adult subjects. The investigators exclude patients with difficult airway, cardiac disease, and neuromuscular disease. The results were calculated using the Statistical Package for Social Scientists (SPSS) 24 Results: Median total intubation time was 63 s (27 - 114 s) in SAM-VL group, compared with 74 s (40 - 133 s), (p = 0,032) in McGrath group. The rate of successful first attempt in SAM-VL group was slightly higher than McGrath group at 90,3% vs 87.1%. Glottic visualization was more satisfactory in SAM-VL group with 67.7% of subjects having score of 100 and 29% of subject having score of 75. Complications found in this study were tachycardia (12.9% SAM-VL group vs 29% in McGrath group) and minimal airway mucosal laceration (9.7% in SAM-VL vs 3.2% in McGrath group). SAM-VL users rate the device high in ease of blade insertion and manoeuvrability, providing good laryngeal visualisation, and overall satisfaction rating.
Conclusions: Endotracheal intubation using self-assembled modified videolaryngoscope is faster, had more successful first attempts, and allowed better glottis visualization compared with McGrath MAC®.
Key-words: endotracheal intubation, self-assembled videolaryngoscope, McGrath MAC®, intubation time, glottis visualization Key Messages: Endotracheal intubation using self-assembled modified videolaryngoscope is faster, had more successful first attempts, and allowed better glottis visualization compared with McGrath MAC®. It is a suitable alternative for videolaryngoscope in low resource setting.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Self-Assembled Modified Macintosh Videolaryngoscope (SAM-VL) group
The self-assembled modified Macintosh videolaryngoscope (SAM-VL) used in this study was constructed from a portable video camera with Wi-fi connection (Wi-fi Endoscope Video Camera model YPC99) attached to a no. 4 Macintosh Laryngoscope blade (Riester® no.7040). The video signal is transmitted to an Android-based mobile phone (Android version 7.0). The portable 2 megapixels video camera is 8 mm in diameter with 8 Light Emitting Diode (LED) lights for adjustable lighting level and 3 meters cable length. Video resolution output is 640x480 pixels (VGA) and 1280x720 pixels (HD). The camera has 70º visual angle with focus length of 4- 6cm and is water-resistant. The camera was taped to the Macintosh blade at a distance of 5 cm from the distal end of the blade, using transparent waterproof Leukofix® tape.
Endotracheal intubation
Every eligible patient was intubated using either SAM-VL or McGrath MAC® according to their randomization allocation
McGrath MAC® videolaryngoscope (McGrath) group
The McGrath MAC® videolaryngoscope used in this study was equipped with disposable blade no.4
Endotracheal intubation
Every eligible patient was intubated using either SAM-VL or McGrath MAC® according to their randomization allocation
Interventions
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Endotracheal intubation
Every eligible patient was intubated using either SAM-VL or McGrath MAC® according to their randomization allocation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
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Indonesia University
OTHER
Responsible Party
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Raden Besthadi Sukmono
Anesthesiologist, Regional Anesthesia Consultant, Assistant Professor
Principal Investigators
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Besthadi Sukmono, MD
Role: PRINCIPAL_INVESTIGATOR
Indonesia University
Locations
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University of Indonesia and Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Countries
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References
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Griesdale DE, Bosma TL, Kurth T, Isac G, Chittock DR. Complications of endotracheal intubation in the critically ill. Intensive Care Med. 2008 Oct;34(10):1835-42. doi: 10.1007/s00134-008-1205-6. Epub 2008 Jul 5.
Rosenblatt WH, Sukhupragarn W. Airway management. In: Barash PG, editor. Barash Clinical Anesthesia, 7th ed. Philadelphia:Lippincott William & Wilkins. 2013;27:763-778.
Shin M, Bai SJ, Lee KY, Oh E, Kim HJ. Comparing McGRATH(R) MAC, C-MAC(R), and Macintosh Laryngoscopes Operated by Medical Students: A Randomized, Crossover, Manikin Study. Biomed Res Int. 2016;2016:8943931. doi: 10.1155/2016/8943931. Epub 2016 Sep 15.
Liu ZJ, Yi J, Guo WJ, Ma C, Huang YG. Comparison of McGrath Series 3 and Macintosh Laryngoscopes for Tracheal Intubation in Patients With Normal Airway by Inexperienced Anesthetists: A Randomized Study. Medicine (Baltimore). 2016 Jan;95(2):e2514. doi: 10.1097/MD.0000000000002514.
Wallace CD, Foulds LT, McLeod GA, Younger RA, McGuire BE. A comparison of the ease of tracheal intubation using a McGrath MAC((R)) laryngoscope and a standard Macintosh laryngoscope. Anaesthesia. 2015 Nov;70(11):1281-5. doi: 10.1111/anae.13209. Epub 2015 Sep 4.
Normand KC, Vargas LA, Burnett T, Sridhar S, Cai C, Zhang X, et al. Use of the McGRATH TM MAC : To view or not to view ?
Ng I, Hill AL, Williams DL, Lee K, Segal R. Randomized controlled trial comparing the McGrath videolaryngoscope with the C-MAC videolaryngoscope in intubating adult patients with potential difficult airways. Br J Anaesth. 2012 Sep;109(3):439-43. doi: 10.1093/bja/aes145. Epub 2012 Jun 7.
Thong S, Teoh WH. Videolaryngoscopy and Indirect Intubating Aids in Airway Management. In: Khan Z, editor. Airway Management. 1st ed. Springer International Publishing Switzerland; 2014. p. 25-63
Tanoubi I, Drolet P, Donati F. Optimizing preoxygenation in adults. Can J Anaesth. 2009 Jun;56(6):449-66. doi: 10.1007/s12630-009-9084-z. Epub 2009 Apr 28.
Karippacheril JG, Umesh G, Ramkumar V. Inexpensive video-laryngoscopy guided intubation using a personal computer: initial experience of a novel technique. J Clin Monit Comput. 2014 Jun;28(3):261-4. doi: 10.1007/s10877-013-9522-x. Epub 2013 Oct 17.
Latuconsina FW, Dedi Fitri Yadi S. Perbandingan intubasi endotrakea menggunakan clip-on smartphone camera videolaryngoscope dengan laringoskop Macintosh pada manekin. J Anestesi Perioper [Internet]. 2018;6(1):27-33
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Related Links
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Xue FS, Li HX, Liu YY, Yang GZ. Current evidence for the use of C-MAC videolaryngoscope in adult airway management: A review of the literature. Ther Clin Risk Manag \[Internet\]. 2017;13:831-41
Walker L, Brampton W, Halai M, Hoy C, Lee E, Scott I, et al. Randomized controlled trial of intubation with the McGrath w Series 5 videolaryngoscope by inexperienced anaesthetists. Br J Anaesth \[Internet\]. 2009;103(3):440-5.
Levitan RM, Heitz JW, Sweeney M, Cooper RM. The Complexities of Tracheal Intubation With Direct Laryngoscopy and Alternative Intubation Devices. YMEM \[Internet\]. 2011;57(3):240-7.
Luqmanmuhamed M, Devadas P. Comparison between custom made video laryngoscope and Macintosh laryngoscope aided endotracheal intubation : a simple and inexpensive digital tool. IOSR J Dent Med Sci \[Internet\]. 2017;16(9):45-51.
Hoshijima H, Mihara T, Maruyama K, Denawa Y, Takahashi M, Shiga T, et al. McGrath videolaryngoscope versus Macintosh laryngoscope for tracheal intubation: A systematic review and meta-analysis with trial sequential analysis. J Clin Anesth \[Internet\].
Other Identifiers
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IndonesiaUniv
Identifier Type: -
Identifier Source: org_study_id
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