Comparison of Supraglottic Airway Devices in EBUS

Lung Diseases Clinical Trial

— SAD-EBUS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06177769
• Other study ID #: SAD-EBUS Derya
• Status: Not yet recruiting
• Start date: December 20, 2023
• Est. completion date: May 20, 2024

Study information

• Verified date: December 2023
• Source: Ankara Etlik City Hospital
• Contact: Derya Güzelkaya, Dr
• Phone: +905070212701
• Email: derya_tip[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 235
• Est. completion date: May 20, 2024
• Est. primary completion date: March 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Management
• Lung Diseases

Intervention

Device:
• LMA classic
Airway is secured with LMA clasic
• LMA Proseal
Airway is secured with LMA proseal
• I-gel
Airway is secured with I-gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Etlik City Hospital

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ease of passage through glottic opening	The operator will score theEase of passage through glottic opening according to a Likert scale	3 minutes after anesthesia induction
Secondary	Ease of SAD insertion	The anesthetist will score the ease of SAD insertion a 5 point scale	2 minutes after anesthesia induction
Secondary	Complications	Airway trauma as indicated with blood stain on SAD or visible bleeding in the airway	1 minute after extubation