Skip to content

Comparison of Supraglottic Airway Devices in EBUS

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06177769
Acronym
SAD-EBUS
Enrollment
183
Registered
2023-12-20
Start date
2023-10-01
Completion date
2024-06-30
Last updated
2025-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Management, Lung Diseases

Keywords

Airway management, Lung diseases

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.

Interventions

Airway is secured with LMA clasic

Airway is secured with LMA proseal

DEVICEI-gel

Airway is secured with I-gel

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of fiberoptic view3 minutes after anesthesia inductionThe operator will score the view of the glottic opening according to the Cormack Lehanne score

Secondary

MeasureTime frameDescription
Ease of passage through glottic opening3 minutes after anesthesia inductionThe operator will score theEase of passage through glottic opening according to a Likert scale
Ease of SAD insertion2 minutes after anesthesia inductionThe anesthetist will score the ease of SAD insertion a 5 point scale
Complications1 minute after extubationAirway trauma as indicated with blood stain on SAD or visible bleeding in the airway

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026