Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Awake Tracheal Intubation Methods Compared in Difficult Airways

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

Run by Kocaeli City Hospital · NCT07484841 · Data updated 2026-11-12

This study tests three awake intubation approaches to see which is most successful in adults with anticipated difficult airways.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment201 (estimated)
SponsorKocaeli City Hospital
Government
Locations1 site (İzmit, Kocaeli)
StatusRecruiting
StartedMarch 20, 2026
Main results expectedMarch 20, 2028
Study endsJune 20, 2028
Registry record updatedAugust 26, 2026
Trial IDNCT07484841 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) with ASA I–II status undergoing elective surgery and anticipated difficult airway features, able to consent.

Probably not a fit

Patients without difficult airway risk or who do not require awake intubation may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective comparison evaluates three awake tracheal intubation techniques: fiberoptic bronchoscopy, videolaryngoscopy, and a fiberoptic route via a supraglottic airway device. Outcomes include success rates, intubation times, and complications, with particular interest in the SAD-assisted method’s reliability. Awake tracheal intubation preserves spontaneous breathing and airway tone, and the study notes the potential advantages and limitations of each approach. There are currently few prospective head-to-head comparisons among ATI methods, especially involving SADs, making this investigation a gap-filling effort in airway management research. Conducted at a single center, the trial enrolls adults undergoing elective surgery who are at higher risk of difficult airway management.

Why it matters

Potential benefit: If successful, the study could identify the most reliable awake intubation method to improve safety and efficiency for patients with difficult airways.

How similar studies have gone: There is limited prospective evidence directly comparing ATI methods, making this trial a novel contribution in this area.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Kocaeli City Hospital
    İzmit, Kocaeli, Turkey (Türkiye)
    Recruiting

Study contacts

  • Principal investigator: Mehmet Yılmaz, Assoc. Prof. — Kocaeli City Hospital
  • Study coordinator: Mehmet Yılmaz, Assoc. Prof.
  • Email: drmyilmaz33@gmail.com
  • Phone: +905052174432

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.