Oropharyngeal Leak Pressure Monitoring Using Baska Versus I-gel Laryngeal Mask Airway

Study Overview
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Brief Summary
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The use of supraglottic airway devices with a gastric emptying tube in gynecological laparoscopic surgeries is growing. In addition to their ease of placement, they have low airway morbidity along with sufficient airway pressure in the Trendelenburg position and so they have been determined as an alternative to the endotracheal tube.

Detailed Description
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The Baska mask is a novel supraglottic airway device with a non-inflatable cuff, an oesophageal drainage inlet and side channels to facilitate the aspiration of gastric contents and an integrated bite-block. The Baska mask comes in four sizes, ranging from pediatric to adult. The device appeared relatively easy to insert, provided a high-quality seal with the glottic aperture and the incidence of throat discomfort appeared low. The I-gel a single use with noninflatable cuff and drain tube is being used for airway management during anesthesia since last few years. The noninflatable cuff of I-gel is made of a soft gel-like medical grade thermoplastic elastomer. The device has a buccal cavity stabilizer, an integral bite block and an epiglottic rest with a protective ridge, which prevents down folding of epiglottis during insertion. An oropharyngeal leak pressure or 'leak' test is commonly performed with the laryngeal mask airway to quantify the efficacy of the seal with the airway. This value is important since it indicates the feasibility of positive pressure ventilation and the degree of airway protection from supracuff soiling. Gynecological laparoscopic surgeries are associated with a decrease in thoraco-pulmonary compliance due to pneumoperitoneum and the Trendelenburg position. Minute ventilation needs to be increased to compensate for this reduction in compliance in order to maintain end-tidal carbon dioxide during pneumoperitoneum. This increase in minute ventilation can lead to an increase in airway pressures in excess of 20 cmH2O.

Official Title
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Oropharyngeal Leak Pressure Monitoring With Baska Versus I-gel Laryngeal Mask Airway During Laparoscopic Gynecologic Surgery

Conditions
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Laryngeal Masks

Intervention / Treatment
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* Device: I-gel
* Device: Baska_mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI< 30kg/m2. ASA physical status: I-II. Operation: gynecological laparoscopic surgery under general anesthesia of an anticipated duration<1h. Exclusion Criteria: Patient refusal. History of cardiac disease, psychological disorders, respiratory diseases including asthma, renal or hepatic failure. Patients who have a high risk of regurgitation or aspiration based on a history of gastroesophageal reflux, hiatus hernia, diabetes and gross obesity. Neck pathology

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| I-gel group<br>Patients will be anesthetized using an appropriate sized I-gel mask according to the manufacturer's recommendations after lubrication with a water-soluble lubricant. | Device: I-gel<br>* Patients will be anesthetized using an appropriate sized I-gel mask according to the manufacturer's recommendations after lubrication with a water-soluble lubricant.<br>* Other names: I-gel LMA;|
| BASKA Group<br>Patients will be anesthetized using BASKA mask after lubrication with a water-soluble lubricant. | Device: Baska_mask<br>* Patients will be anesthetized using BASKA mask after lubrication with a water-soluble lubricant.<br>* Other names: The Baska_ LMA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leak airway pressure | cmH2O | Intra-operative; after device insertion up to its removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak airway pressure | cmH2O | Intra-operative; after device insertion up to its removal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngeal Masks, Oropharyngeal leak pressure, I-gel laryngeal mask airway