Effect of Continuous Supraglottic Oxygen Insufflation Via Video Laryngoscope Blade on Apneic Oxygenation During Tracheal Intubation Under General Anesthesia

Обзор

This study is a prospective, randomized controlled clinical trial aimed at investigating the efficacy and safety of a novel oxygenating video laryngoscope blade during apneic oxygenation for intubation under general anesthesia. Hypoxemia is prone to occur during anesthesia induction, which can lead to severe complications. Apneic oxygenation is an important method to prolong the safe apnea time, but existing oxygen delivery modalities have limitations in applicability. Although the laryngeal oxygen delivery approach combined with video laryngoscopy has theoretical advantages, clinical evidence is insufficient. Therefore, this study was conducted.

Вмешательства

• Процедура control group (Group C)
  Before surgery, all participants received a radial arterial line. At arrival to the operating theatre, ECG, invasive arterial blood pressure, pulse oximetry, and train-of-four monitoring were applied. An i.v. line was secured, and a standard infusion of electrolyte solution was started. Participants were then placed supine, in a 10 degrees reverse Trendelenburg position. Preoxygenation was then perform using atight fitting face mask and having each subject breathe 100% O2 at 15 L/min.Tracheal in
• Устройство The continuous laryngeal oxygen supply group (Group B)
  The continuous laryngeal oxygen supply group (Group B) used the same preoxygenation and anesthesia induction methods as the control group. When intubation conditions were assessed to be met, laryngoscopy was performed to evaluate the airway. If the laryngoscopic view was Cormack and Lehane grade 3 or grade 4, the subject was excluded from the study and tracheal intubation was performed. Otherwise, continuous laryngeal oxygen supply was initiated through a modified disposable video laryngoscope b

Первичные конечные точки

• arterial partial pressure of oxygen (PaO2) at 3 min [Срок оценки: 3 minutes after intubation]

Вторичные конечные точки (6)

• PaO2 at before preoxygenation [Срок оценки: Baseline (before preoxygenation)]
• PaO2 at 1 minutes when intubation criteria are met [Срок оценки: 1 minute after intubation]
• PaO2 at 2 minute when intubation criteria are met [Срок оценки: 2 minute after intubation]
• PaO2 at 5 minutes when intubation criteria are met [Срок оценки: 5 minute after intubation]
• PaCO2 changes during apnoea [Срок оценки: up to 24 hours (during apnoea)]
• all complicatios at 24 hours postoperatively. [Срок оценки: at 24 hours postoperatively]

Критерии участия

Критерии включения

• Patients aged between 18 and 75 years, with ASA physical status I to III, and scheduled for surgery with general anaesthesia and orotracheal intubation

Критерии исключения

• cardiac disease (ischaemic heart disease, heart failure \[NYHA ≥2 \],current arrhythmias, pulmonary hypertension)
• severe asthma, moderate to severe chronic obstructive pulmonary disease
• pregnancy
• baseline oxygen saturation <95%
• not capable of understanding study information and signing a written 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

Тройное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07662304 · 2026-073-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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