Video Laryngeal Mask Versus Endotracheal Tube Undergoing Laparoscopic Cholecystectomy Surgery
1 other identifier
interventional
102
1 country
1
Brief Summary
The aim of this study is to investigate the effectiveness of using a video laryngeal mask for airway management in patients undergoing laparoscopic cholecystectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2024
CompletedFirst Posted
Study publicly available on registry
July 15, 2024
CompletedStudy Start
First participant enrolled
July 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 7, 2026
CompletedMay 19, 2026
May 1, 2026
1.7 years
June 27, 2024
May 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time required for VLMA insertion or intubation
Time required for VLMA insertion or intubation
After induction of anesthesia, before the operation starts.
Secondary Outcomes (10)
Number of trials
After induction of anesthesia, before the operation starts.
Peak airway pressure
After video laryngeal mask airway insertion or intubation, before extubation
Minute ventilation
After video laryngeal mask airway insertion or intubation, before extubation
End tidal carbon dioxide
After video laryngeal mask airway insertion or intubation, before extubation
Oropharyngeal leak pressure
After video laryngeal mask airway insertion or intubation, before extubation
- +5 more secondary outcomes
Study Arms (2)
Video LMA
EXPERIMENTALThe airway is secured with a video laryngeal mask airway (VLMA).
Control
ACTIVE COMPARATORThe participant is intubated with an endotracheal tube via direct laryngoscopy.
Interventions
The participant is intubated with an endotracheal tube via direct laryngoscopy.
Eligibility Criteria
You may qualify if:
- Patients over 19 years old
- Patients planned for elective laparoscopic cholecystectomy
You may not qualify if:
- High risk of aspiration (e.g. gastro-esophageal reflux disease, hiatus hernia, pregnancy, history of gastrectomy)
- Difficult airway (e.g. limitation of mouth opening, limitation of neck extension, oropharyngeal pathology)
- Obesity (BMI \> 30 kg/m2)
- Tooth mobility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hansol KIM, MD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2024
First Posted
July 15, 2024
Study Start
July 31, 2024
Primary Completion
April 6, 2026
Study Completion
April 7, 2026
Last Updated
May 19, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share