An observational study in Airway Management and Lung Diseases, sponsored by Ankara Etlik City Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by Ankara Etlik City Hospital · Observational
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.
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 183 is above the median of 157 across 929 observational studies indexed under Lung Diseases.
Browse Lung Diseases studies →Ankara Etlik City Hospital is the lead sponsor of 166 studies on the registry; 75 are open to participants now.
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Adult patients undergoing Endobronchial ultrasound guided transbronchial needle aspiration
Exclusion Criteria:
Airway is secured with LMA classic
Device: LMA classic
Airway is secured with LMA proseal
Device: LMA Proseal
Airway is secured with I-gel
Device: I-gel
Airway is secured with LMA clasic
Airway is secured with LMA proseal
Airway is secured with I-gel
Quality of fiberoptic view
The operator will score the view of the glottic opening according to the Cormack Lehanne score
Time frame: 3 minutes after anesthesia induction
Ease of passage through glottic opening
The operator will score theEase of passage through glottic opening according to a Likert scale
Time frame: 3 minutes after anesthesia induction
Ease of SAD insertion
The anesthetist will score the ease of SAD insertion a 5 point scale
Time frame: 2 minutes after anesthesia induction
Complications
Airway trauma as indicated with blood stain on SAD or visible bleeding in the airway
Time frame: 1 minute after extubation
Plan to share: Undecided
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Ankara Etlik City Hospital