Comparison of Awake Tracheal Intubation Methods

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Awake tracheal intubation viaFiberoptic Bronchoscopy (ATI:FOB)
  awake tracheal intubation will be perform via FOB
• Процедура Awake tracheal Intubation via videolaryngoscopy (ATI:VL)
  Awake tracheal intubation will be perform via videolaryngoscopy
• Процедура 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

Первичные конечные точки

• Success rate of chosen awake intubation method [Срок оценки: Through study completion, an average of 2 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Kocaeli City Hospital — İzmit

Идентификаторы

NCT: NCT07484841 · KŞH-MY-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗