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

Laryngeal Masks Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03139292
• Other study ID #: 201-26104-152-206580
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: October 2019

Study information

• Verified date: December 2019
• Source: Tata Main Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Laryngeal Masks

Intervention

Device:
• ProSeal Laryngeal Mask Airway
ProSeal Laryngeal Mask Airway was used as the supraglottic device
• AmbuAuraGain Laryngeal Mask Airway
AmbuAuraGain Laryngeal Mask Airway was used as the supraglottic device

Locations

Country	Name	City	State
India	Tata Main Hospital	Jamshedpur	Jharkhand

Sponsors (1)

Lead Sponsor	Collaborator
Tata Main Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate for the first attempt at insertion	A failed insertion attempt is defined as when removal of the device needed from the mouth.	5 minutes
Secondary	Time taken for insertion	Time taken for insertion from picking up the LMA till confirmation of effective ventilation	5 minutes
Secondary	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.	5 minutes
Secondary	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.	5 minutes
Secondary	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.	5 minutes