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Clinical Trial NCT07484841 (ATI) for Airway Management Assessment, Awake Endotracheal Intubation, Awake Fiberoptic Nasal Intubation, Videolaryngoscopy, Supraglottic Airway Device Insertion is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Comparison of Awake Tracheal Intubation Methods (ATI) 201

Not yet recruiting
Clinical Trial NCT07484841 (ATI) is an interventional study for Airway Management Assessment, Awake Endotracheal Intubation, Awake Fiberoptic Nasal Intubation, Videolaryngoscopy, Supraglottic Airway Device Insertion and is currently not yet recruiting. Enrollment is planned to begin on 20 March 2026 and continue until the study accrues 201 participants. Led by Kocaeli City Hospital, this study is expected to complete by 20 June 2028. The latest data from ClinicalTrials.gov was last updated on 20 March 2026.
Brief 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 lite...

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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 laryngoscop...Show More
Official Title

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

Conditions
Airway Management AssessmentAwake Endotracheal IntubationAwake Fiberoptic Nasal IntubationvideolaryngoscopySupraglottic Airway Device Insertion
Other Study IDs
  • ATI
  • KŞH-MY-01
NCT ID Number
NCT07484841
Start Date (Actual)
2026-03-20
Last Update Posted
2026-03-20
Completion Date (Estimated)
2028-06-20
Enrollment (Estimated)
201
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
videolaryngoscopy
awake tracheal intubation
fiberoptic bronchoscopy
aintree catheter
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorFiberoptic Bronchoscopy (ATI: FOB)
Intubation will be perform via fiberoptic bronchoscopy
Awake tracheal intubation viaFiberoptic Bronchoscopy (ATI:FOB)
awake tracheal intubation will be perform via FOB
Active ComparatorVideolaryngoscopy (ATI:VL)
Intubation will be perform via videolaryngoscopy
Awake tracheal Intubation via videolaryngoscopy (ATI:VL)
Awake tracheal intubation will be perform via videolaryngoscopy
Active ComparatorAintree catheter loaded fiberoptic bronchoscopy via Supraglottic Airway Device (ATI:SAD)
Intubation will be perform via aintree catheter loaded fiberoptic bronchoscopy through supraglottic airway device
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
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
Through study completion, an average of 2 year
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
Kocaeli City Hospital logoKocaeli City Hospital
Study Central Contact
Contact: Mehmet Yılmaz, Assoc. Prof., +905052174432, [email protected]
Contact: Ayşe Z Turan Cıvraz, Assoc.Prof., 05054695850, [email protected]
1 Study Locations in 1 Countries

Kocaeli

Kocaeli City Hospital, İzmit, Kocaeli, 41060, Turkey (Türkiye)
Ayşe Turan Cıvraz, Assoc.Prof, Contact, 05054695850, [email protected]