Skip to main content
OpenTrials
Completed

NCT Number: NCT03139292

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Laryngeal Masks

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tata Main Hospital

Jamshedpur, Jharkhand, 831001, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists (ASA) Physical Status I & II
  • Patients undergoing limb or breast surgery
  • Patients undergoing elective surgery under general anesthesia and spontaneous ventilation.
  • Patients with expected duration of surgery of less than 2 hours.

Exclusion criteria

  • Patients with known or predicted difficult airway or Mallampati Grade (MPG) III or IV
  • Patients with mouth opening of less than 2.5 cm or cervical spine disease
  • Patients with H/o upper respiratory tract infection in the previous 10 days.
  • Patients with increased risk of regurgitation and aspiration (non-fasting patients, gastroesophageal reflux disease etc.)
  • Patients with a body mass index (BMI) > 30 kg/m2
  • 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

Treatment and study plan

ProSeal Laryngeal mask airway

Device

ProSeal Laryngeal Mask Airway was used as the supraglottic device

AmbuAuraGain Laryngeal Mask Airway

Device

AmbuAuraGain Laryngeal Mask Airway was used as the supraglottic device

Primary outcomes

  1. Success rate for the first attempt at insertion

    Time frame: 5 minutes

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

Secondary outcomes

  1. Time taken for insertion

    Time frame: 5 minutes

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

  2. The number of insertion attempts

    Time frame: 5 minutes

    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.

  3. Intracuff and the oropharyngeal leak pressures after ensuring effective placement.

    Time frame: 5 minutes

    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.

  4. The time taken for orogastric tube placement

    Time frame: 5 minutes

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

Sponsors and collaborators

Lead sponsor

Tata Main Hospital

Other

Registry information

Official study title

Comparative Evaluation of Ambu AuraGain Laryngeal Mask and Proseal Laryngeal Mask Airway in Spontaneously Breathing Patients Undergoing Elective Surgery Under General Anaesthesia

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 3, 2017
Registry last updated
Dec 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.