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Comparison of the Ambu AuraGain and Intersurgical i-Gel Laryngeal Masks in Elective Laparoscopic Cholecystectomy
Sponsor: Hospital Plató
Summary
Prospective, controlled, randomized study to compare Ambu AuraGain with Intersurgical i-Gel mask during mechanical ventilation in patients undergoing laparoscopic cholecystectomy. The investigators hypothesise that when comparing the Ambu® AuraGainTM with Intersurgical i-GelTM mask, the Ambu® AuraGainTM would exhibit a higher oropharyngeal leak pressure (OLP) during mechanical ventilation in patients undergoing laparoscopic cholecystectomy. The main goal is to compare the Ambu AuraGain with the i-Gel in terms of safety and efficacy during mechanical ventilation in critical phase of the pneumoperitoneum in lateral decubitus and reverse trendelemburg position. Secondary objectives are comparing insertion time, number of attempts, ventilatory airway peak pressure, time and success rates for gastric tube insertion and the incidence of side effects.
Official title: A Prospective, Controlled and Randomized Comparison of the Ambu AuraGain and Intersurgical i-Gel Laryngeal Masks in Elective Laparoscopic Cholecystectomy
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
98
Start Date
2019-12-18
Completion Date
2021-02-17
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Oropharyngeal leak pressure during pneumoperitoneum.
Oropharyngeal Leak Pressure (OLP) will be measured by closing the expiratory valve of the circle system at a fixed gas flow of 3 litres/min (maximum allowed 40 cmH2O) recording the pressure at which equilibrium has been reached or audible air is leaking.
Locations (1)
Anesthesia Department, Hospital Plató
Barcelona, Barcelona, Spain