Comparison of Supraglottic Airway Devices in EBUS

NCT ID: NCT06177769

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 183 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-06-30

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.

Conditions

Airway Management; Lung Diseases

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Group I

Airway is secured with LMA classic

LMA classic

Intervention Type: DEVICE

Airway is secured with LMA clasic

Group II

Airway is secured with LMA proseal

LMA Proseal

Intervention Type: DEVICE

Airway is secured with LMA proseal

Group III

Airway is secured with I-gel

I-gel

Intervention Type: DEVICE

Airway is secured with I-gel

Interventions

LMA classic

Airway is secured with LMA clasic

Intervention Type: DEVICE

LMA Proseal

Airway is secured with LMA proseal

Intervention Type: DEVICE

I-gel

Airway is secured with I-gel

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Derya Guzelkaya

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Derya Güzelkaya, Dr

Role: PRINCIPAL_INVESTIGATOR

Ankara Etlik City Hospital

Locations

Etlik City Hospital

Ankara, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 27555181 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33687002 (View on PubMed)

Other Identifiers

SAD-EBUS Derya

Identifier Type: -

Identifier Source: org_study_id