Comparison of Awake Tracheal Intubation Methods

ConditionsAirway Management Assessment Awake Endotracheal Intubation Awake Fiberoptic Nasal Intubation Videolaryngoscopy Supraglottic Airway Device Insertion

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorKocaeli City Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Awake tracheal intubation viaFiberoptic Bronchoscopy (ATI:FOB)
Procedure/Surgery
awake tracheal intubation will be perform via FOB
Awake tracheal Intubation via videolaryngoscopy (ATI:VL)
Procedure/Surgery
Awake tracheal intubation will be perform via videolaryngoscopy
awake tracheal intubation via aintree catheter loaded FOB through supraglottic airway device (ATI:SAD)
Procedure/Surgery
Awake tracheal Intubation will be perform via aintree catheter loaded FOB through supraglottic airway device

Treatment groups

201 Participants

are divided into 3 treatment groups

Group A: Fiberoptic Bronchoscopy (ATI: FOB)Active comparator 1 intervention

Group B: Videolaryngoscopy (ATI:VL)Active comparator 1 intervention

Group C: Aintree catheter loaded fiberoptic bronchoscopy via Supraglottic Airway Device (ATI:SAD)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Through study completion, an average of 2 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kocaeli City Hospital

Lead sponsor

Source ClinicalTrials.gov

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