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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
201

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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