NCT07484841

Comparison of Awake Tracheal Intubation Methods

A Comparison of Three Difficult Intubation Techniques in Patients With Anticipated Difficult Intubation: A Prospective, Randomized, Parallel-group Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 201 (estimated)
• Sponsor: Kocaeli City Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to compare three different awake tracheal intubation technique -fiberoptic bronchoscopy (ATI:FB), videolaryngoscopy (ATI:VL), and fiberoptic bronchoscopy via a supraglottic airway device (ATI:SAD)- in terms of success rates, intubation times, and complications. Additionally, the study aims to evaluate the reliability of the SAD-assisted ATI method and its potential to contribute to the literature.

Detailed description

Awake tracheal intubation (ATI) is a technique considered the gold standard for managing anticipated difficult airways. The success of ATI is based on two key physiological advantages: the preservation of spontaneous breathing and the maintenance of airway tone. Traditionally, ATI is performed using a flexible fiberoptic bronchoscope (ATI:FB). However, in recent years, ATI techniques performed using video laryngoscopy (ATI:VL) have also become widespread and have particularly stood out for their shorter intubation times. Although randomized studies directly comparing ATI:FB and ATI:VL techniques are limited in the literature, an increasing number of studies are evaluating the comparative efficacy of these techniques. On the other hand, while supraglottic airway devices (SADs) are traditionally used as rescue ventilation devices, current guidelines indicate that they can also serve as a channel for awake intubation in conjunction with fiberoptic bronchoscopy . Various case series and small-scale observational studies exist on this topic. However, there are no prospective studies directly comparing SAD use during ATI with traditional methods such as ATI:FB and ATI:VL. This gap in the literature forms the primary rationale for our study. The ATI:SAD method currently used in our clinic is a technique in which the Aintree catheter and fiberoptic bronchoscope are utilized via SAD. This method offers advantages such as the ability to continuously monitor spontaneous breathing and maintain uninterrupted oxygenation. In this context, our study aims not only to demonstrate the efficacy of the ATI:SAD method but also to contribute this method to the literature.

Conditions

• Airway Management Assessment
• Awake Endotracheal Intubation
• Awake Fiberoptic Nasal Intubation
• Videolaryngoscopy
• Supraglottic Airway Device Insertion

Interventions

Type	Name	Description
PROCEDURE	Awake tracheal intubation viaFiberoptic Bronchoscopy (ATI:FOB)	awake tracheal intubation will be perform via FOB
PROCEDURE	Awake tracheal Intubation via videolaryngoscopy (ATI:VL)	Awake tracheal intubation will be perform via videolaryngoscopy
PROCEDURE	awake tracheal intubation via aintree catheter loaded FOB through supraglottic airway device (ATI:SAD)	Awake tracheal Intubation will be perform via aintree catheter loaded FOB through supraglottic airway device

Timeline

• Start date: 2026-03-20
• Primary completion: 2028-03-20
• Completion: 2028-06-20
• First posted: 2026-03-20
• Last updated: 2026-03-20

Locations

1 site across 1 country: Turkey (Türkiye)