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Comparison of two different supraglottic airway devices i.e., the ProSeal Laryngeal Mask Airway (PLMA) and Ambu AuraGain, a third generation laryngeal mask Airway.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProSeal Laryngeal Mask Airway | Experimental | 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 |
|
| AmbuAuraGain Laryngeal Mask Airway | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProSeal Laryngeal Mask Airway | Device | ProSeal Laryngeal Mask Airway was used as the supraglottic device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time taken for insertion | Time taken for insertion from picking up the LMA till confirmation of effective ventilation | 5 minutes |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
8.Surgery to be performed to the head, neck or thorax, abdomen or in the lateral or prone positions
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tata Main Hospital | Jamshedpur | Jharkhand | 831001 | India |
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Prospective randomized single blinded parallel group controlled study
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Sequentially numbered, sealed, opaque envelopes: Participant and Outcome Assessor Blinded
| AmbuAuraGain Laryngeal Mask Airway | Device | AmbuAuraGain Laryngeal Mask Airway was used as the supraglottic device |
|
| 5 minutes |
| 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 |
| 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 |