Fiberoptic Intubation in Lateral Versus Supine Position in Pediatrics Undergoing Non-head-and-neck Surgery

Официальное название

Video-assisted Fiberoptic Intubation in Lateral Versus Supine Position in Pediatrics Undergoing Non-head-and-neck Surgery: a Randomized Controlled Non-inferiority Trial

Обзор

Fiberoptic intubation was first described in the late 1960s and has since become an effective and well-established technique for airway management in awake, sedated, and anesthetized patients. This technique is especially useful in patients with known or suspected difficult airways such as those with limited mouth opening, reduced neck mobility, cervical spine injury, obesity, or an elevated risk for aspiration. The benefits of fiberoptic intubation also include fewer complications such as tooth injury and oropharyngeal bleeding; and the opportunity for optimal positioning of double-lumen tubes in patients undergoing thoracic surgery. Anesthesiologists may be confronted with situations in which patients in a lateral position during surgery experience an accidental loss of airway patency. Intubation with direct laryngoscopy is more challenging and time-consuming in patients in the lateral position than in the supine position, particularly when there is an abrupt loss of airway patency, as demonstrated by prior research. These observations suggest that there is an unmet need for a reliable method of airway management for patients in the lateral position. Although the airway is of a larger caliber and ventilation renders less peak and better oxygenation when patients are in the lateral position, glottic view was unfavorable for intubation when Macintosh direct laryngoscope was used in this position. This could be the reason why such a procedure is unfamiliar in anesthesia even when it is the most needed in special situations. Flexible fiberoptic intubation in lateral position would be convenient in emergency situations like accidental extubation during surgery or inadequate regional anesthesia requiring general anesthesia. Flexible fiberoptic intubation in lateral position would be of significant assistance in neurosurgical patients especially those with occipital lesions and patients with difficult airway scores with limited mouth opening or neck extension. After thorough literature review, we found that studies comparing flexible video-assisted fiberoptic intubation in the lateral versus supine position in pediatrics are lacking.

Вмешательства

• Процедура Supine position
  An assistant will be asked to hold the tongue in protrusion using a gauze held by a Magill forceps (preventing it from falling backwards). The operator will introduce the bronchoscope orally allowing its advancement till it reaches the laryngeal inlet. The glottic view will be graded from 1 (larynx is only seen) to 5 (the epiglottis down folded and larynx cannot be seen directly) (10). The scope will be manipulated to pass between the 2 vocal cords, and then advanced till the carina is seen to
• Процедура Lateral position
  An assistant will be asked to hold the tongue in protrusion using a gauze held by a Magill forceps (preventing it from falling backwards). The operator will introduce the bronchoscope orally allowing its advancement till it reaches the laryngeal inlet. The glottic view will be graded from 1 (larynx is only seen) to 5 (the epiglottis down folded and larynx cannot be seen directly) (10). The scope will be manipulated to pass between the 2 vocal cords, and then advanced till the carina is seen to

Первичные конечные точки

• Time to intubation [Срок оценки: 5 minutes from endoscope insertion between teeth]

Вторичные конечные точки (4)

• Rate of successful intubation at first attempt. [Срок оценки: 5 minutes from endoscope insertion between teeth]
• Overall number of intubation attempts [Срок оценки: 5 minutes from endoscope insertion between teeth]
• Incidence of complications [Срок оценки: 10 minutes from endoscope insertion between teeth]
• Oxygen saturation [Срок оценки: 5 minutes from endoscope insertion between teeth]

Критерии участия

Критерии включения

• Children aged 2-10 years old.
• Both genders.
• ASA physical status I and II.
• Elective non-head-and-neck surgeries.

Критерии исключения

• Refusal of patients.
• Head and neck surgeries or with history of previous ones.
• Head, neck and lung congenital deformities or pathologies.
• Patients with expected difficult intubation (based on examination).
• Patients with neuromuscular disorders.
• Hypoxia: defined as low oxygen saturation (SpO2) ≤ 95% on room air.
• Trauma patients or patients requiring emergency procedures.

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

Другое

Центры проведения

Египет · 1 центр

• Faculty of Medicine, Cairo University — Cairo

Идентификаторы

NCT: NCT06776900 · MS-526-2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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