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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Airway Management
• Intervention / Treatment: Device: LMA classic; Device: LMA Proseal; Device: I-gel

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.

• Study Type: Observational
• Enrollment (Actual): 183

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06010
    • Etlik City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients undergoing Endobronchial ultrasound guided transbronchial needle aspiration

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I; Airway is secured with LMA classic	Device: LMA classic; Airway is secured with LMA clasic
Group II; Airway is secured with LMA proseal	Device: LMA Proseal; Airway is secured with LMA proseal
Group III; Airway is secured with I-gel	Device: I-gel; Airway is secured with I-gel

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital
• Investigators: Principal Investigator: Derya Güzelkaya, Dr, Ankara Etlik City Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Airway management; Lung diseases
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: SAD-EBUS Derya

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No