Comparison of Supraglottic Airway Devices in EBUS (SAD-EBUS)

Ankara Etlik City Hospital

Status: Completed

Conditions: Lung Diseases; Airway Management

Treatments: Device: LMA classic; Device: I-gel; Device: LMA Proseal

Study type: Observational

Funder types: Other

Identifiers

NCT06177769

SAD-EBUS Derya

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 183 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

183 participants in 3 patient groups

Group I

Description:

Airway is secured with LMA classic

Treatment:

Device: LMA classic

Group II

Description:

Airway is secured with LMA proseal

Treatment:

Device: LMA Proseal

Group III

Description:

Airway is secured with I-gel

Treatment:

Device: I-gel