Cholecystitis
Conditions
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.
Interventions
DEVICEVideo laryngeal mask airway
The airway is secured with a video laryngeal mask airway.
DEVICEEndotracheal tube
The participant is intubated with an endotracheal tube via direct laryngoscopy.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time required for VLMA insertion or intubation | After induction of anesthesia, before the operation starts. | Time required for VLMA insertion or intubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 hour 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 | 1 hour 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) |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORHansol KIM, MD
Seoul National University Hospital
Outcome results
None listed