Comparative Evaluation of Ambu AuraGain Laryngeal Mask and Proseal Laryngeal Mask Airway

Tata Main Hospital160 enrolled

Overview

Comparison of two different supraglottic airway devices i.e., the ProSeal Laryngeal Mask Airway (PLMA) and Ambu AuraGain, a third generation laryngeal mask Airway.

The study aims to compare the two devices with respect to: Time taken for insertion. Insertion attempts or failed attempt. Oropharyngeal leak pressure Air leak Time taken to pass an orogastric tube Attempts to pass an orogastric tube or failed attempt. Haemodynamic variation Incidence of adverse events like failed insertion, aspiration-regurgitation, hypoxia (SpO2\< 90%), bronchospasm, airway obstruction, gastric insufflation, coughing, gagging, retching, hiccup, coughing during removal, blood staining of the airway device and trauma to tongue, lip, teeth, or gums.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

160

Conditions

Laryngeal Masks

Interventions

ProSeal Laryngeal Mask AirwayDEVICE

ProSeal Laryngeal Mask Airway was used as the supraglottic device

AmbuAuraGain Laryngeal Mask AirwayDEVICE

AmbuAuraGain Laryngeal Mask Airway was used as the supraglottic device

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. American Society of Anesthesiologists (ASA) Physical Status I \& II 2. Patients undergoing limb or breast surgery 3. Patients undergoing elective surgery under general anesthesia and spontaneous ventilation. 4. Patients with expected duration of surgery of less than 2 hours. Exclusion Criteria: 1. Patients with known or predicted difficult airway or Mallampati Grade (MPG) III or IV 2. Patients with mouth opening of less than 2.5 cm or cervical spine disease 3. Patients with H/o upper respiratory tract infection in the previous 10 days. 4. Patients with increased risk of regurgitation and aspiration (non-fasting patients, gastroesophageal reflux disease etc.) 5. Patients with a body mass index (BMI) \> 30 kg/m2 6. Patients with past history of radiotherapy involving the hypopharynx/neck area 7Patients with expected duration of surgery of more than 2 hours. 8.Surgery to be performed to the head, neck or thorax, abdomen or in the lateral or prone positions

Locations (1)

Tata Main Hospital

Jamshedpur, Jharkhand, India

Outcomes

Primary Outcomes

Success rate for the first attempt at insertion

A failed insertion attempt is defined as when removal of the device needed from the mouth.

Time frame: 5 minutes

Secondary Outcomes

Time taken for insertion

Time taken for insertion from picking up the LMA till confirmation of effective ventilation

Time frame: 5 minutes

The number of insertion attempts

The number of insertion attempts or failed attempt to achieve effective ventilation. A failed insertion attempt is defined as when removal of the device needed from the mouth. Three attempts allowed before insertion will be considered a failure.

Time frame: 5 minutes

Intracuff and the oropharyngeal leak pressures after ensuring effective placement.

Intracuff and the oropharyngeal leak pressures after ensuring effective placement. These pressures will be determined by closing the expiratory valve of the circle system at a fresh gas flow of 3 l/min, note the airway pressure (maximum allowed: 40 cm H2O) at which equilibrium was reached.

Time frame: 5 minutes

The time taken for orogastric tube placement

The time taken for correct placement will be recorded, from Picking up the orogastric tube till confirmation of its placement.

Time frame: 5 minutes

Data from ClinicalTrials.gov

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