Clinical trial NCT04850976: Self-Assembled Modified Macintosh Videolaryngoscope Versus McGrath Macintosh (MAC®) Videolaryngoscope: Which is Better?
Official title: Self-Assembled Modified Macintosh Videolaryngoscope Versus McGrath Macintosh (MAC®) Videolaryngoscope: Which is Better?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Management
Keywords: endotracheal intubation
self-assembled videolaryngoscope
McGrath MAC®
intubation time
glottis visualization
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There were 2 intervention groups: (1) the Self-Assembled Modified Macintosh Videolaryngoscope (SAM-VL) group or (2) the McGrath MAC ® videolaryngoscope (McGrath) group.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time needed for Intubation "A"
timeFrame: After endotracheal intubation completed
measure: Time needed for Intubation "B"
timeFrame: After the endotracheal intubation completed
measure: Total time needed for intubation
timeFrame: After the endotracheal intubation completed
Secondary outcomes:
measure: Successful first attempt
timeFrame: After the endotracheal intubation completed
measure: Laryngeal visualization
timeFrame: After the endotracheal intubation completed
measure: Complications
timeFrame: After the endotracheal intubation completed
measure: Laryngoscope User Satisfaction
timeFrame: After the endotracheal intubation completed
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: University of Indonesia and Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Besthadi Sukmono, MD
role: PRINCIPAL_INVESTIGATOR
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