Airway Management AssessmentATINCT07484841
Comparison of Awake Tracheal Intubation Methods
A study testing Awake tracheal intubation viaFiberoptic Bronchoscopy (ATI:FOB), Awake tracheal Intubation via videolaryngoscopy (ATI:VL) and awake tracheal intubation via aintree catheter loaded FOB through supraglottic airway device (ATI:SAD) in people with Airway Management Assessment and Awake Endotracheal Intubation, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Management Assessment, Awake Endotracheal Intubation, Awake Fiberoptic Nasal Intubation
- What is being tested?
- Awake tracheal intubation viaFiberoptic Bronchoscopy (ATI:FOB), Awake tracheal Intubation via videolaryngoscopy (ATI:VL) and awake tracheal intubation via aintree catheter loaded FOB through supraglottic airway device (ATI:SAD)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2026to 20 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli City Hospital
İzmit, Kocaeli, 41060
Ayşe Turan Cıvraz, Assoc.Prof, 05054695850, ayse.zeynep@gmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- Awake tracheal intubation viaFiberoptic Bronchoscopy (ATI:FOB), Awake tracheal Intubation via videolaryngoscopy (ATI:VL), awake tracheal intubation via aintree catheter loaded FOB through supraglottic airway device (ATI:SAD)
- Keywords
- videolaryngoscopy, awake tracheal intubation, fiberoptic bronchoscopy, aintree catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awake tracheal intubation viaFiberoptic Bronchoscopy (ATI:FOB)Procedure or surgery
awake tracheal intubation will be perform via FOB
Awake tracheal Intubation via videolaryngoscopy (ATI:VL)Procedure or surgery
Awake tracheal intubation will be perform via videolaryngoscopy
awake tracheal intubation via aintree catheter loaded FOB through supraglottic airway device (ATI:SAD)Procedure or surgery
Awake tracheal Intubation will be perform via aintree catheter loaded FOB through supraglottic airway device
| Study group | Role | What they receive |
|---|---|---|
| Fiberoptic Bronchoscopy (ATI: FOB) | Active comparator | Intubation will be perform via fiberoptic bronchoscopy Receives: Procedure: Awake tracheal intubation viaFiberoptic Bronchoscopy (ATI:FOB) |
| Videolaryngoscopy (ATI:VL) | Active comparator | Intubation will be perform via videolaryngoscopy Receives: Procedure: Awake tracheal Intubation via videolaryngoscopy (ATI:VL) |
| Aintree catheter loaded fiberoptic bronchoscopy via Supraglottic Airway Device (ATI:SAD) | Active comparator | Intubation will be perform via aintree catheter loaded fiberoptic bronchoscopy through supraglottic airway device Receives: Procedure: awake tracheal intubation via aintree catheter loaded FOB through supraglottic airway device (ATI:SAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of chosen awake intubation method
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.
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start20 Mar 2026
- Primary completion20 Mar 2028 (estimated)
- Study completion20 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Management AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mehmet Yılmaz, Assoc. Prof., Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484841
- Sponsor's protocol ID
- KŞH-MY-01
- Acronym
- ATI
- Status last verified
- Aug 2026
- First submitted
- 13 Mar 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Three Difficult Intubation Techniques in Patients With Anticipated Difficult Intubation: A Prospective, Randomized, Parallel-group Clinical Trial
- ClinicalTrials.gov ID
- NCT07484841
- Acronym / sponsor ID
- ATI / KŞH-MY-01
- Conditions
- Airway Management Assessment, Awake Endotracheal Intubation, Awake Fiberoptic Nasal Intubation, Videolaryngoscopy, Supraglottic Airway Device Insertion
- Keywords
- videolaryngoscopy, awake tracheal intubation, fiberoptic bronchoscopy, aintree catheter
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 20 Mar 2028 (estimated)
- Study completion
- 20 Jun 2028 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fiberoptic Bronchoscopy (ATI: FOB) | Active comparator | Procedure: Awake tracheal intubation viaFiberoptic Bronchoscopy (ATI:FOB)Intubation will be perform via fiberoptic bronchoscopy |
| Videolaryngoscopy (ATI:VL) | Active comparator | Procedure: Awake tracheal Intubation via videolaryngoscopy (ATI:VL)Intubation will be perform via videolaryngoscopy |
| Aintree catheter loaded fiberoptic bronchoscopy via Supraglottic Airway Device (ATI:SAD) | Active comparator | Procedure: awake tracheal intubation via aintree catheter loaded FOB through supraglottic airway device (ATI:SAD)Intubation will be perform via aintree catheter loaded fiberoptic bronchoscopy through supraglottic airway device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Awake tracheal intubation viaFiberoptic Bronchoscopy (ATI:FOB)awake tracheal intubation will be perform via FOB | Procedure or surgery | Fiberoptic Bronchoscopy (ATI: FOB) |
| Awake tracheal Intubation via videolaryngoscopy (ATI:VL)Awake tracheal intubation will be perform via videolaryngoscopy | Procedure or surgery | Videolaryngoscopy (ATI:VL) |
| 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 | Procedure or surgery | Aintree catheter loaded fiberoptic bronchoscopy via Supraglottic Airway Device (ATI:SAD) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mehmet Yılmaz, Assoc. Prof. principal investigator
Kocaeli City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Awake tracheal intubation viaFiberoptic Bronchoscopy (ATI:FOB), Awake tracheal Intubation via videolaryngoscopy (ATI:VL) and awake tracheal intubation via aintree catheter loaded FOB through supraglottic airway device (ATI:SAD) in people with Airway Management Assessment and Awake Endotracheal Intubation, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Yılmaz, Assoc. Prof. (+905052174432, drmyilmaz33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of chosen awake intubation method (time frame: Through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.