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Completed

NCT Number: NCT04850976

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Indonesia and Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endotracheal intubation

Device

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

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Secondary outcomes

  1. 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 (%).

  2. Laryngeal visualization

    Time frame: After the endotracheal intubation completed

    Measuring laryngeal visualization using Percentage of Glottic Opening (POGO) score: 100,75, 50, 25, 0.

  3. 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 (%).

  4. 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).

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 20, 2021
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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