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The aim of this prospective, randomized, comparative, controlled clinical study is to compare laryngeal mask airway ProtectorTM with the endotracheal tube, regarding to the respiratory mechanical parameters during controlled mechanical ventilation and the prevalence of aspiration. Aspiration will be evaluated by detecting and quantifying pepsin (a marker of gastric aspiration) and α-amylase (a marker of salivary aspiration) in the bronchoalveolar lavage ( mini BAL) of patients ≥18 years old, ASA 1-2, undergoing selective low-risk surgery under general anesthesia in a lithotomy position.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LMA Protector | Experimental | LMA Protector will be inserted by a researcher after standard anesthesia induction. The view of the larynx will be assessed using fiberoptic grading scale. Mini bronchoalveolar lavage will be colected at the end of the procedure |
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| Endotracheal tube | Experimental | Patients will be intubated after standard anesthesia induction.The view of the larynx will be assessed ( Cormack Lehane system).Mini bronchoalveolar lavage will be colected at the end of the procedure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LMA Protector | Device | LMA Protector will be inserted by a researcher after standard anesthesia induction. The view of the larynx will be assessed using fiberoptic grading scale.Mini bronchoalveolar lavage will be collected before the end of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in PIP cmH20 (Peak inspiratory pressure ) between the two groups of patients. | Measured by Ventilator | Intraoperative |
| Assessment of aspiration risk by quantitative measurements of pepsin (ng/ml) and α-amylase (IU/ml) in BAL of patients and differences in its incidence between the two groups. | Measured by ELISA method | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in lung mechanics between the two patient groups | Pplat cmH20( plataeu pressure) Dynamic Compliance ml/cmH20 , MAP cmH20( Mean Airway pressure ), PEEP cmH20,( positive end-expiratory pressure VTins, VTexp ( t, Raw cmH20/ml/sec( resistance of airway), ΔP cmH20(Driving Pressure, inspired (VTinsp) and expired (VTexp) tidal volumes, VTins - VTexp. | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stella Antoniou, MD | Contact | +306994255120 | stella_A@windowslive.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Univerisity Hospital of Patras | Recruiting | Pátrai | Greece |
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| Endotracheal tube | Device | tracheal intubation will be perform after standard anaesthetic induction. Cormack Lehane will be recorded. Mini bronchoalveolar lavage will be collected before the end of the procedure |
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