Laryngeal Masks
Conditions
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.
Interventions
ProSeal Laryngeal Mask Airway was used as the supraglottic device
DEVICEAmbuAuraGain Laryngeal Mask Airway
AmbuAuraGain Laryngeal Mask Airway was used as the supraglottic device
Sponsors
Tata Main Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Sequentially numbered, sealed, opaque envelopes: Participant and Outcome Assessor Blinded
Intervention model description
Prospective randomized single blinded parallel group controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
India
Outcome results
None listed