Clinical Trials Directory

Trials / Completed

CompletedNCT04850976

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
62 (actual)
Sponsor
Indonesia University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Interventions

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

Timeline

Start date
2020-06-01
Primary completion
2020-08-31
Completion
2020-08-31
First posted
2021-04-20
Last updated
2021-05-24

Locations

1 site across 1 country: Indonesia

Source: ClinicalTrials.gov record NCT04850976. Inclusion in this directory is not an endorsement.