Airway Management Assessment, Awake Endotracheal Intubation, Awake Fiberoptic Nasal Intubation, Supraglottic Airway Device Insertion, Videolaryngoscopy
Conditions
Keywords
videolaryngoscopy, awake tracheal intubation, fiberoptic bronchoscopy, aintree catheter
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 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
PROCEDUREAwake tracheal intubation viaFiberoptic Bronchoscopy (ATI:FOB)
awake tracheal intubation will be perform via FOB
PROCEDUREAwake tracheal Intubation via videolaryngoscopy (ATI:VL)
Awake tracheal intubation will be perform via videolaryngoscopy
PROCEDUREawake 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
Sponsors
Kocaeli City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of chosen awake intubation method | Through study completion, an average of 2 year | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMehmet Yılmaz, Assoc. Prof.
CONTACTAyşe Z Turan Cıvraz, Assoc.Prof.
PRINCIPAL_INVESTIGATORMehmet Yılmaz, Assoc. Prof.
Kocaeli City Hospital
Outcome results
None listed