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Completed

NCT Number: NCT06177769

Comparison of Supraglottic Airway Devices in EBUS

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Etlik City Hospital

Ankara, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LMA classic

Device

Airway is secured with LMA clasic

LMA proseal

Device

Airway is secured with LMA proseal

I-gel

Device

Airway is secured with I-gel

Primary outcomes

  1. Quality of fiberoptic view

    Time frame: 3 minutes after anesthesia induction

    The operator will score the view of the glottic opening according to the Cormack Lehanne score

Secondary outcomes

  1. Ease of passage through glottic opening

    Time frame: 3 minutes after anesthesia induction

    The operator will score theEase of passage through glottic opening according to a Likert scale

  2. Ease of SAD insertion

    Time frame: 2 minutes after anesthesia induction

    The anesthetist will score the ease of SAD insertion a 5 point scale

  3. Complications

    Time frame: 1 minute after extubation

    Airway trauma as indicated with blood stain on SAD or visible bleeding in the airway

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

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

Acronym: SAD-EBUS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 20, 2023
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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