Comparison of Awake Tracheal Intubation Methods
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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).
- Who it may be relevant to
- Registry conditions: Airway Management Assessment, Awake Endotracheal Intubation, Awake Fiberoptic Nasal Intubation, Videolaryngoscopy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Comparison of Three Difficult Intubation Techniques in Patients With Anticipated Difficult Intubation: A Prospective, Randomized, Parallel-group Clinical Trial
Overview
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.
Interventions
- Procedure Awake tracheal intubation viaFiberoptic Bronchoscopy (ATI:FOB)
awake tracheal intubation will be perform via FOB - Procedure Awake tracheal Intubation via videolaryngoscopy (ATI:VL)
Awake tracheal intubation will be perform via videolaryngoscopy - Procedure 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
- Success rate of chosen awake intubation method [Time frame: Through study completion, an average of 2 year]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- Kocaeli City Hospital — İzmit
Identifiers
NCT: NCT07484841 · KŞH-MY-01