Comparison of Supraglottic Airway Devices in EBUS

Study Overview
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Brief Summary
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Supraglottic airway devices (SAD) provide ventilation of patients requiring respiratory support without tracheal intubation. Therefore, SAD is used to maintain airway during anesthesia in surgeries that do not require intubation. The classical laryngeal mask (cLMA, Intavent Direct, Maidenhead, UK) is an SAD that is available as a more advanced airway method than mask ventilation and a less invasive method than endotracheal intubation. It is used by placing it over the glottis at the level of the larynx and inflating the cuff. The Proseal laryngeal mask (LMA-Proseal™, PLMA, Intavent Orthofix, Maidenhead, UK) is the first supraglottic airway device that is suitable for reuse and includes a gastric drainage channel. I-gel™ (Intersurgical Ltd, Wokingham, UK) is a second-generation laryngeal mask with a soft, gel-like thermoplastic elastomer distal end and no inflatable cuff, designed not to compress the anatomical structures of the larynx and pharynx. Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA) has become one of the most important invasive diagnostic procedures for pulmonologists and thoracic surgeons. It is a safe and effective technique for sampling hilar and mediastinal lymph nodes and masses. It is currently accepted as the first choice for histological sampling of the mediastinum in lung cancer staging. The use of SAD to secure the airway in patients undergoing EBUS-TBNA has the advantages of being less invasive than endotracheal intubation and providing better surgical field access. Classical LMA, proseal LMA and I-gel are routinely used airway methods during EBUS-TBNA procedure. The aim of this study is to compare the routinely used SADs in anesthesia management in patients undergoing endobronchial ultrasonography-guided transbronchial needle aspiration in terms of intraoperative efficacy and postoperative complications.

Detailed Description
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The parameters to be recorded are: demographic characteristics of the patients, hemodynamic data during and after the procedure, ventilation variables (tidal volume, airway pressures, leak volume), the number of attempts to place the SAD, the need for intubation, the presence of sore throat, nausea and vomiting after the procedure. In addition, the operator performing the procedure will be asked to evaluate the convenience of the procedure.

Official Title
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Comparison of Efficacy and Complications of Three Supraglottic Airway Devices in Endobronchial Ultrasonographic Transbronchial Needle Aspiration Anesthesia

Conditions
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Airway Management, Lung Diseases

Intervention / Treatment
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* Device: LMA classic
* Device: LMA Proseal
* Device: I-gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults ageing 18-80 years patients in ASA phyical class patients undergoing Endobronchial ultrasound guided transbronchial needle aspiration Exclusion Criteria: patients undergoing emergent procedure pediatric patients patients having upper airway pathology patients in risk of aspiration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I<br>Airway is secured with LMA classic | Device: LMA classic<br>* Airway is secured with LMA clasic<br>|
| Group II<br>Airway is secured with LMA proseal | Device: LMA Proseal<br>* Airway is secured with LMA proseal<br>|
| Group III<br>Airway is secured with I-gel | Device: I-gel<br>* Airway is secured with I-gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of fiberoptic view | The operator will score the view of the glottic opening according to the Cormack Lehanne score | 3 minutes after anesthesia induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of passage through glottic opening | The operator will score theEase of passage through glottic opening according to a Likert scale | 3 minutes after anesthesia induction | 
| Ease of SAD insertion | The anesthetist will score the ease of SAD insertion a 5 point scale | 2 minutes after anesthesia induction | 
| Complications | Airway trauma as indicated with blood stain on SAD or visible bleeding in the airway | 1 minute after extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airway management, Lung diseases