Comparison of Awake Tracheal Intubation Methods (ATI)

March 18, 2026 updated by: Kocaeli City Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

201

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients aged 18 and older
  • Patients classified as ASA I-II according to the American Society of Anesthesiologists (ASA) classification
  • Patients scheduled for elective surgery
  • Patients expected to require difficult mask ventilation, difficult laryngoscopy, or difficult tracheal intubation; patients expected to have short apnea periods (Planjuan goiter); patients at risk of aspiration; patients expected to require difficult rescue techniques; and patients with a reported history of difficult intubation
  • Patients scheduled for intubation using the awake tracheal intubation (ATI) method
  • Individuals who have agreed to participate in the study by signing an informed consent form

Exclusion Criteria:

  • Patients with a mouth opening <1.5 cm
  • Patients requiring emergency intubation or emergency surgery (situations where there is insufficient time to administer ATI)
  • Patients who cannot cooperate (mental incapacity, impaired consciousness, inability to communicate, etc.)
  • Patients with known allergies to lidocaine or other local/topical anesthetic agents used
  • Pregnancy
  • Patients with a history of severe cardiac arrhythmia or hemodynamic instability (due to increased risk during intubation)
  • Patients who have previously undergone tracheostomy or whose airway is technically obstructed due to anatomical deformity
  • Patients who refuse to participate in the study or who do not provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fiberoptic Bronchoscopy (ATI: FOB)
Intubation will be perform via fiberoptic bronchoscopy
Procedure: Awake tracheal intubation viaFiberoptic Bronchoscopy (ATI:FOB)
awake tracheal intubation will be perform via FOB
Active Comparator: Videolaryngoscopy (ATI:VL)
Intubation will be perform via videolaryngoscopy
Procedure: Awake tracheal Intubation via videolaryngoscopy (ATI:VL)
Awake tracheal intubation will be perform via videolaryngoscopy
Active Comparator: Aintree catheter loaded fiberoptic bronchoscopy via Supraglottic Airway Device (ATI:SAD)
Intubation will be perform via aintree catheter loaded fiberoptic bronchoscopy through supraglottic airway device
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of chosen awake intubation method
Time Frame: Through study completion, an average of 2 year
The primary endpoint of the study is the success rate of the selected awake intubation technique, with the intubation method to be chosen via randomization.
Through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 20, 2026

Primary Completion (Estimated)

March 20, 2028

Study Completion (Estimated)

June 20, 2028

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KŞH-MY-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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