Comparison of Supraglottic Airway Devices in EBUS

NCT06177769 | Completed

• 1 other identifier: SAD-EBUS Derya
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Management; Lung Diseases

Keywords

Airway management; Lung diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Ease of passage through glottic opening

  3 minutes after anesthesia induction

• Ease of SAD insertion

  2 minutes after anesthesia induction

• Complications

  1 minute after extubation

Study Arms (3)

Group I

Airway is secured with LMA classic

Device: LMA classic

Group II

Airway is secured with LMA proseal

Device: LMA Proseal

Group III

Airway is secured with I-gel

Device: I-gel

Interventions

LMA classic DEVICE

Airway is secured with LMA clasic

Group I

LMA Proseal DEVICE

Airway is secured with LMA proseal

Group II

I-gel DEVICE

Airway is secured with I-gel

Group III

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing Endobronchial ultrasound guided transbronchial needle aspiration

You may qualify if:

• adults ageing 18-80 years
• patients in ASA phyical class
• patients undergoing Endobronchial ultrasound guided transbronchial needle aspiration

You may not qualify if:

• patients undergoing emergent procedure
• pediatric patients
• patients having upper airway pathology
• patients in risk of aspiration

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Etlik City Hospital

Ankara, Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 27555181 BACKGROUND

• 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.

  PMID: 33687002 BACKGROUND

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Derya Güzelkaya, Dr

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: October 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: June 30, 2024
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

TU (1)