Video Laryngeal Mask Versus Endotracheal Tube Undergoing Laparoscopic Cholecystectomy Surgery

Not Applicable

Recruiting

• Conditions: Cholecystitis
• Interventions: Device: Video laryngeal mask airway; Device: Endotracheal tube

• Registration Number: NCT06502028
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

The investigators will compare the time required to secure the airway when inserting a video laryngeal mask (LMA) versus performing endotracheal intubation.

Study Timeline

• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-15
• Study Start: 2024-07-31
• Status Verified: 2024-09
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-14
• Primary Completion: 2025-12-26
• Study Completion: 2026-05-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Patients over 19 years old
• Patients planned for elective laparoscopic cholecystectomy

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video LMA	Video laryngeal mask airway	The airway is secured with a video laryngeal mask airway (VLMA).
Control	Endotracheal tube	The participant is intubated with an endotracheal tube via direct laryngoscopy.

Primary Outcome Measures

Name	Time	Method
Time required for VLMA insertion or intubation	After induction of anesthesia, before the operation starts.	Time required for VLMA insertion or intubation

Secondary Outcome Measures

Name	Time	Method
Number of trials	After induction of anesthesia, before the operation starts.	Video laryngeal mask airway insertion or endotracheal intubation
Peak airway pressure	After video laryngeal mask airway insertion or intubation, before extubation	Peak airway pressure
Minute ventilation	After video laryngeal mask airway insertion or intubation, before extubation	Minute ventilation
End tidal carbon dioxide	After video laryngeal mask airway insertion or intubation, before extubation	End tidal carbon dioxide
Oropharyngeal leak pressure	After video laryngeal mask airway insertion or intubation, before extubation	Oropharyngeal leak pressure
Traces of blood on airway device after extubation	After extubation, before transfer to PACU	Traces of blood on airway device after extubation
Postoperative sore throat	24 hours after end of operation	4-point scale, 0 = no sore throat; 1 = mild sore throat (complaints of sore throat only on asking); 2 = moderate sore throat (complaints of sore throat on his/her own); 3 = severe sore throat (change of voice or hoarseness, associated with throat pain)
Postoperative hoarseness	24 hours after end of operation	4-point scale, 0 = no hoarseness; 1 = mild hoarseness (complaints of hoarseness only on asking); 2 = moderate hoarseness (complaints of hoarseness on his/her own); 3 = severe hoarseness (hoarseness associated with throat pain)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of