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

Not Applicable

Completed

• Conditions: Laryngeal Masks
• Interventions: Device: AmbuAuraGain Laryngeal Mask Airway; Device: ProSeal Laryngeal Mask Airway

• Registration Number: NCT03139292
• Lead Sponsor: Tata Main Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2017-05-01
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-03
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-25
• Last Update Posted: 2019-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AmbuAuraGain Laryngeal Mask Airway	AmbuAuraGain Laryngeal Mask Airway	Intravenous (0.02mg/kg Midazolam and 2 microgram/kg Fentanyl) and oxygen via a face mask will be administered. Two minutes later, general anesthesia will be induced using 2 mg/kg intravenous Propofol mixed with 25 mg Lidocaine Injected over 30 seconds, Mask ventilation commence and continue for at least 30 seconds until conditions are suitable for AmbuAuraGain Laryngeal Mask Airway insertion
ProSeal Laryngeal Mask Airway	ProSeal Laryngeal Mask Airway	Intravenous (0.02mg/kg Midazolam and 2 microgram/kg Fentanyl) and oxygen via a face mask will be administered. Two minutes later, general anesthesia will be induced using 2 mg/kg intravenous Propofol mixed with 25 mg Lidocaine Injected over 30 seconds, Mask ventilation commence and continue for at least 30 seconds until conditions are suitable for PLMA insertion

Primary Outcome Measures

Name	Time	Method
Success rate for the first attempt at insertion	5 minutes	A failed insertion attempt is defined as when removal of the device needed from the mouth.

Secondary Outcome Measures

Name	Time	Method
Time taken for insertion	5 minutes	Time taken for insertion from picking up the LMA till confirmation of effective ventilation
The number of insertion attempts	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.
Intracuff and the oropharyngeal leak pressures after ensuring effective placement.	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.
The time taken for orogastric tube placement	5 minutes	The time taken for correct placement will be recorded, from Picking up the orogastric tube till confirmation of its placement.

Trial Locations

Locations (1)

Tata Main Hospital; 🇮🇳 Jamshedpur, Jharkhand, India