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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 201 (estimated) |
| Sponsor | Kocaeli City Hospital Government |
| Locations | 1 site (İzmit, Kocaeli) |
| Status | Recruiting |
| Started | March 20, 2026 |
| Main results expected | March 20, 2028 |
| Study ends | June 20, 2028 |
| Registry record updated | August 26, 2026 |
| Trial ID | NCT07484841 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
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.