Comparison of the Ambu AuraGain and Intersurgical i-Gel Laryngeal Masks in Elective Laparoscopic Cholecystectomy

NCT04206592 | Completed

• 1 other identifier: MLA- Anesth
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Airway Management; Laryngeal Masks

Keywords

Laryngeal mask; Oropharyngeal leak pressure; Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Oropharyngeal leak pressure 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.

  10 month

Study Arms (2)

i Gel LMA

ACTIVE COMPARATOR

The sealing pressure of the igel laryngeal mask will be measured during pneumoperitoneum in elective laparoscopic cholecystectomy

Device: Oropharyngeal leak pressure during pneumoperitoneum.

Ambu Aura Gain

ACTIVE COMPARATOR

It will be compared the Ambu Aura Gain LMA vs iGel in elective laparoscopic cholecystectomy

Device: Oropharyngeal leak pressure during pneumoperitoneum.

Interventions

Oropharyngeal leak pressure during pneumoperitoneum. DEVICE

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.

Ambu Aura Gain; i Gel LMA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80 year
• American Society of Anaesthesiologists physical status I-III
• Elective Laparoscopic Cholecystectomy

You may not qualify if:

• Previous knowledge of difficult intubation
• Mouth opening less than 35 mm
• Cervical spine disease
• BMI≥35 kg/m2
• Upper respiratory or digestive tract disease
• Severe obstructive pulmonary disease
• Recent history of upper respiratory tract infection
• Pregnancy
• Patients who have a risk of gastric aspiration
• Preoperative sore throat
• Patients who refuse to participate
• Withdrawal criterion:
• Orotracheal intubation during surgery

Sponsors & Collaborators

• Hospital Plató: lead

Study Sites (1)

Anesthesia Department, Hospital Plató

Barcelona, 08006, Spain

Location

Study Officials

• Teresa García-Navia

  Hospital Plato

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 20, 2019
• Study Start: November 18, 2019
• Primary Completion: February 17, 2020
• Study Completion: March 9, 2020
• Last Updated: February 16, 2021

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)