Self-Assembled Modified Macintosh Videolaryngoscope Versus McGrath Macintosh (MAC®) Videolaryngoscope: Which is Better?

NCT04850976 | Completed

• 1 other identifier: IndonesiaUniv
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Videolaryngoscopy highly improves success rate for endotracheal intubation in both normal and difficult airway. However, commercially available videolaryngoscope such as McGrath MAC® can be costly. 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.

Conditions

Airway Management

Keywords

endotracheal intubation; self-assembled videolaryngoscope; McGrath MAC®; intubation time; glottis visualization

Outcome Measures

Primary Outcomes (3)

• Time needed for Intubation "A"

  The time needed for Intubation "A" recording began when the tip of the laryngoscope blade passed through the incisors until the operator was able to achieve best visualization of the glottis. Measured in seconds (s).

  After endotracheal intubation completed

• Time needed for Intubation "B"

  The time needed for Intubation"B" recording began when the operator received visualization of the glottis and ended after the endotracheal tube tube was confirmed to enter the trachea. Measured in seconds (s).

  After the endotracheal intubation completed

• Total time needed for intubation

  The sum total of time needed for Intubation A+B. Measured in seconds (s).

  After the endotracheal intubation completed

Secondary Outcomes (4)

• Successful first attempt

  After the endotracheal intubation completed

• Laryngeal visualization

  After the endotracheal intubation completed

• Complications

  After the endotracheal intubation completed

• Laryngoscope User Satisfaction

  After the endotracheal intubation completed

Study Arms (2)

Self-Assembled Modified Macintosh Videolaryngoscope (SAM-VL) group

EXPERIMENTAL

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.

Device: Endotracheal intubation

McGrath MAC® videolaryngoscope (McGrath) group

ACTIVE COMPARATOR

The McGrath MAC® videolaryngoscope used in this study was equipped with disposable blade no.4

Device: Endotracheal intubation

Interventions

Endotracheal intubation DEVICE

Every eligible patient was intubated using either SAM-VL or McGrath MAC® according to their randomization allocation

McGrath MAC® videolaryngoscope (McGrath) group; Self-Assembled Modified Macintosh Videolaryngoscope (SAM-VL) group

Eligibility Criteria

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

You may qualify if:

• All adult patients (18-65 years old), American Society of Anesthesiologists (ASA) physical status of I - II, Body Mass Index (BMI) of 18 - 30 kg/m2, scheduled for elective surgical procedures under general anesthesia

You may not qualify if:

• ASA III or above, difficult airway, pregnancy, cardiac condition, neuromuscular disease

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

University of Indonesia and Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (11)

• 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.

  PMID: 18604519 BACKGROUND

• Rosenblatt WH, Sukhupragarn W. Airway management. In: Barash PG, editor. Barash Clinical Anesthesia, 7th ed. Philadelphia:Lippincott William & Wilkins. 2013;27:763-778.

  BACKGROUND

• 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.

  PMID: 27703983 BACKGROUND

• 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.

  PMID: 26765472 BACKGROUND

• 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.

  PMID: 26336853 BACKGROUND

• 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 ?

  BACKGROUND

• 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.

  PMID: 22677878 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 19399574 BACKGROUND

• 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.

  PMID: 24132806 BACKGROUND

• 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

  BACKGROUND

Related Links

• 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 \[Internet\].

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• Besthadi Sukmono, MD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomization was done with tables and then presented in a closed envelope when the patient arrived at the operating room to determine the intervention group: (1) the Self-Assembled Modified Macintosh Videolaryngoscope (SAM-VL) group or (2) the McGrath MAC ® videolaryngoscope (McGrath) group. The laryngoscopist is the one who opened the envelope. A research assistant helped to prepare the laryngoscope according to the randomization results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Regional Anesthesia Consultant, Assistant Professor

Model Details: There were 2 intervention groups: (1) the Self-Assembled Modified Macintosh Videolaryngoscope (SAM-VL) group or (2) the McGrath MAC ® videolaryngoscope (McGrath) group.

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 20, 2021
• Study Start: June 1, 2020
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data is available from 1 month after publication until 10 years
• Access Criteria: by access

Locations

ID (1)