Comparative Evaluation of Ambu AuraGain Laryngeal Mask and Proseal Laryngeal Mask Airway in Spontaneously Breathing Patients Undergoing Elective Surgery Under General Anaesthesia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Laryngeal Masks
- Sponsor
- Tata Main Hospital
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Success rate for the first attempt at insertion
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Dr.Deb Sanjay Nag
Consultant
Tata Main Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- Time taken for insertion(5 minutes)
- The number of insertion attempts(5 minutes)
- Intracuff and the oropharyngeal leak pressures after ensuring effective placement.(5 minutes)
- The time taken for orogastric tube placement(5 minutes)