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Clinical Trials/NCT04850976
NCT04850976
Completed
Not Applicable

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

Indonesia University1 site in 1 country62 target enrollmentJune 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Airway Management
Sponsor
Indonesia University
Enrollment
62
Locations
1
Primary Endpoint
Time needed for Intubation "A"
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
August 31, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Raden Besthadi Sukmono

Anesthesiologist, Regional Anesthesia Consultant, Assistant Professor

Indonesia University

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

Outcomes

Primary Outcomes

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).

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).

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

  • 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 Sites (1)

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