Clinical trial NCT06177769: Comparison of Supraglottic Airway Devices in EBUS
Official title: Comparison of Efficacy and Complications of Three Supraglottic Airway Devices in Endobronchial Ultrasonographic Transbronchial Needle Aspiration Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Management
Lung Diseases
Keywords: Airway management
Lung diseases
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-12-20
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing Endobronchial ultrasound guided transbronchial needle aspiration

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of fiberoptic view
timeFrame: 3 minutes after anesthesia induction
Secondary outcomes:
measure: Ease of passage through glottic opening
timeFrame: 3 minutes after anesthesia induction
measure: Ease of SAD insertion
timeFrame: 2 minutes after anesthesia induction
measure: Complications
timeFrame: 1 minute after extubation
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Etlik City Hospital
Study officials:
affiliation: Ankara Etlik City Hospital
name: Derya Güzelkaya, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maitra S, Baidya DK, Arora MK, Bhattacharjee S, Khanna P. Laryngeal mask airway ProSeal provides higher oropharyngeal leak pressure than i-gel in adult patients under general anesthesia: a meta-analysis. J Clin Anesth. 2016 Sep;33:298-305. doi: 10.1016/j.jclinane.2016.04.020. Epub 2016 May 18.
citation: Goel MK, Kumar A, Maitra G, Singh B, Ahlawat S, Jain P, Garg N, Verma RK. Safety and diagnostic yield of transbronchial lung cryobiopsy by flexible bronchoscopy using laryngeal mask airway in diffuse and localized peripheral lung diseases: A single-center retrospective analysis of 326 cases. Lung India. 2021 Mar-Apr;38(2):109-116. doi: 10.4103/lungindia.lungindia_220_20.