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Clinical Trials/NCT06177769
NCT06177769
Completed
Not Applicable

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

Ankara Etlik City Hospital1 site in 1 country183 target enrollmentOctober 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Airway Management
Sponsor
Ankara Etlik City Hospital
Enrollment
183
Locations
1
Primary Endpoint
Quality of fiberoptic view
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
June 30, 2024
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Ankara Etlik City Hospital
Responsible Party
Principal Investigator
Principal Investigator

Derya Guzelkaya

Dr

Ankara Etlik City Hospital

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

Outcomes

Primary Outcomes

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

  • Ease of passage through glottic opening(3 minutes after anesthesia induction)
  • Complications(1 minute after extubation)
  • Ease of SAD insertion(2 minutes after anesthesia induction)

Study Sites (1)

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