University of Indonesia and Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430, Indonesia
NCT Number: NCT04850976
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Jakarta Pusat, DKI Jakarta, 10430, Indonesia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Every eligible patient was intubated using either SAM-VL or McGrath MAC® according to their randomization allocation
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 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).
Time frame: After the endotracheal intubation completed
The sum total of time needed for Intubation A+B. Measured in seconds (s).
Time frame: After the endotracheal intubation completed
Measuring intubation's first attempt success rate between the two groups. Success rate defined in number (%).
Time frame: After the endotracheal intubation completed
Measuring laryngeal visualization using Percentage of Glottic Opening (POGO) score: 100,75, 50, 25, 0.
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 (%).
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).
Indonesia University
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT06261619
Airway Management, Pathologic Processes
Providence, Rhode Island, United States
View Trial DetailsNCT07681960
Airway Management, Asphyxia Neonatorum
Kahramanmaraş, Turkey (Türkiye)
View Trial DetailsNCT07678424
Airway Management, Clinical Competence
Kahramanmaraş, Turkey (Türkiye)
View Trial DetailsNCT07669259
Airway Management, Capnography
Antalya, konyaaltı, Turkey (Türkiye)
View Trial Details