Laryngeal Mask in Morbid Obesity

Study Overview
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Brief Summary
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Investigators study the performance of both masks, Proseal Laryngeal Mask Airway (PLMA) and I-gel, as temporary ventilatory supraglottic airway devices (SGDs) before tracheal intubation in morbidly obese patients. Data are lacking in such population of patients

Detailed Description
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The available data regarding SGDs in morbidly obese patients have focused mainly on PLMA. In general, SGDs have been successfully used as temporary ventilatory devices before laryngoscope-guided tracheal intubation, conduits for endotracheal tube insertion, and primary airway devices during surgery. Second-generation SGDs are preferred for both rescue airway and routine use, compared with first-generation, non-gastric access devices. Data on comparison PLMA vs. I-gel in morbidly obese patient are lacking. The PLMA is a second generation gastric access SGD. PLMA is composed of an airway tube that connects to a mask which, after insertion through the patient's mouth and inflation of cuff, forms an airtight seal on top the glottis allowing a secure airway to be managed by a health care provider. PLMA can be autoclaved and reused many times. I-gel is a new type of single use, second generation, gastric access SGD and doesn't have an inflatable cuff. Because of its thermoplastic elastomer structure, it exactly adapts to the supraglottic tissue by binding with body temperature, thus minimising air leakage. The aim of this study is to compare PLMA and I-gel regarding insertion success rate, the time of insertion, gastric access tube positioning, oropharyngeal leak pressure, assessment of position by fiberoptic, ventilatory parameters and hemodynamic, and complications for each device placed before tracheal intubation in morbidly obese patients. This study is conducted at University Medical Hospital of Padova, with approval from Hospital research Ethical Committee and written informed consents from patients,. Patients are randomly allocated into 2 equal groups, according to the inclusion and exclusion criteria. PLMA (n=35) in which PLMA is used for ventilation. I-gel (n=35) in which I-gel is used for ventilation. I

Official Title
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Comparison of the ProSeal Laryngeal Mask and I-gel as a Temporary Ventilatory Device Before Tracheal Intubation in Morbidly Obese Patients

Conditions
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Morbid Obesity

Intervention / Treatment
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* Device: Supraglottic device (SGD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: morbidly obese patients scheduled for elective bariatric surgery under general anesthesia Exclusion Criteria: nonfasting; symptoms or endoscopic evidence of gastroesophageal reflux, of gastric ulcer, or oropharyngeal pathology; known or predicted difficult airway; allergy to anesthetic and nonsteroidal antiinflammatory drugs; or inability to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Investigators hypothesize PLMA and I-gel are both effective as temporary ventilatory device in morbidly obese patients.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PLMA<br>The PLMA, a second generation gastric access SGD, is used as temporary ventilatory device before tracheal intubation. Performance is evaluated. | Device: Supraglottic device (SGD)<br>* Positioning of SGD as temporary ventilatory device before tracheal intubation<br>|
| Active Comparator: I-gel<br>The I-gel, a second generation gastric access SGD, is used as temporary ventilatory device before tracheal intubation. Performance is evaluated. | Device: Supraglottic device (SGD)<br>* Positioning of SGD as temporary ventilatory device before tracheal intubation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oropharyngeal leak pressure (OLP) | OLP is defined as the anesthesia circuit pressure at which a gas leak occurs around the SGD | Procedure (After correct placement of SGD) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time insertion | Time for definitive placement of SGD | Procedure (Time from pick up to correct placement of SGD) | 
| SGD placement | Ease of insertion of the SGD | Procedure (From pick up to correct placement of SGD) | 
| Gastric tube | Ease of insertion of the gastric tube through the dedicated conduit | Procedure (After correct placement of SGD) | 
| fiberoptic evaluation | Fiberoptic evaluation of correct positioning through SGD | Procedure (After correct placement of SGD and established ventilation) | 
| Leak fraction | The leak fraction is defined as the leak volume divided by the inspired tidal volume. | Procedure (After correct placement of SGD and established ventilation) |