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

May 19, 2021 updated by: Raden Besthadi Sukmono, Indonesia University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background and Aims: 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).

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.

Study Type

Interventional

Enrollment (Actual)

62

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 Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • University of Indonesia and Cipto Mangunkusumo Hospital

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Device: Endotracheal intubation
Every eligible patient was intubated using either SAM-VL or McGrath MAC® according to their randomization allocation
ACTIVE_COMPARATOR: McGrath MAC® videolaryngoscope (McGrath) group
The McGrath MAC® videolaryngoscope used in this study was equipped with disposable blade no.4
Device: Endotracheal intubation
Every eligible patient was intubated using either SAM-VL or McGrath MAC® according to their randomization allocation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time needed for Intubation "A"
Time Frame: After endotracheal intubation completed
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"
Time Frame: After the endotracheal intubation completed
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
Time Frame: After the endotracheal intubation completed
The sum total of time needed for Intubation A+B. Measured in seconds (s).
After the endotracheal intubation completed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful first attempt
Time Frame: After the endotracheal intubation completed
Measuring intubation's first attempt success rate between the two groups. Success rate defined in number (%).
After the endotracheal intubation completed
Laryngeal visualization
Time Frame: After the endotracheal intubation completed
Measuring laryngeal visualization using Percentage of Glottic Opening (POGO) score: 100,75, 50, 25, 0.
After the endotracheal intubation completed
Complications
Time Frame: After the endotracheal intubation completed
Documenting complications generated by each device. Complications recorded are: Hypertension, hypotension, tachycardia, bradycardia, mucosal laceration, and esophageal intubation. Incidence are presented in numbers (%).
After the endotracheal intubation completed
Laryngoscope User Satisfaction
Time Frame: After the endotracheal intubation completed
Documenting laryngoscope user satisfaction in terms of blade insertion (very easy, easy, reasonable, difficult), device maneuverability (very easy, easy, reasonable, difficult), glottic visualization (very good, good, enough, poor), and overall satisfaction rating (very good, good, enough, poor).
After the endotracheal intubation completed

Collaborators and Investigators

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

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Besthadi Sukmono, MD, Indonesia University

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

Helpful Links

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)

June 1, 2020

Primary Completion (ACTUAL)

August 31, 2020

Study Completion (ACTUAL)

August 31, 2020

Study Registration Dates

First Submitted

April 8, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (ACTUAL)

April 20, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2021

Last Update Submitted That Met QC Criteria

May 19, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IndonesiaUniv

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol and Statistical Analysis Plan

IPD Sharing Time Frame

The data is available from 1 month after publication until 10 years

IPD Sharing Access Criteria

by access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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