Comparison of Three Airway Intubation Devices for First-Attempt Success in General Anesthesia Patients

Официальное название

Application of SPHJ-II, Visual Lighted Stylet, and Visual Intubation Fiberscope in Endotracheal Intubation in Patients Under General Anesthesia

Обзор

The goal of this clinical trial is to compare three airway intubation devices in adult patients undergoing general anesthesia who require tracheal intubation. The main questions it aims to answer are: * Does the SPHJ-II video-assisted adjustable red-light fluoroscopic tracheal intubation scope improve first-attempt intubation success compared with a visual lighted stylet and a visual intubation fiberscope? * How do the three devices compare in intubation efficiency, intubation-related complications, and peri-intubation physiological responses? Researchers will compare the SPHJ-II, the visual lighted stylet, and the visual intubation fiberscope to evaluate their performance during tracheal intubation. Participants will be randomly assigned to one of the three device groups and undergo tracheal intubation during general anesthesia using the assigned device.

Подробное описание

Tracheal intubation is an essential procedure for airway management during general anesthesia. Several visualized intubation devices are used in clinical practice, but each has different advantages and limitations in visualization, maneuverability, and ease of endotracheal tube placement. The SPHJ-II is a novel video-assisted adjustable red-light fluoroscopic tracheal intubation scope designed to improve visualization and facilitate intubation.

This study is a prospective, randomized, single-center, single-blind, parallel-group clinical trial designed to compare the clinical performance of the SPHJ-II, a visual lighted stylet, and a visual intubation fiberscope in adult patients undergoing general anesthesia requiring tracheal intubation. Participants will be randomly assigned in a 1:1:1 ratio to one of the three device groups. All tracheal intubations will be performed by experienced anesthesiologists using standardized operating procedures. The study is designed to evaluate whether the SPHJ-II provides advantages in first-attempt intubation success and procedural performance compared with the other two commonly used visualized intubation devices.

Вмешательства

• Устройство SPHJ-II
  The SPHJ-II is a visual adjustable red-light tracheal intubation device used to facilitate endotracheal intubation after induction of general anesthesia.
• Устройство Video lighted stylet
  A video lighted stylet used to facilitate endotracheal intubation after induction of general anesthesia.
• Устройство Visual intubation fiberscope
  A visual intubation fiberscope used to facilitate endotracheal intubation after induction of general anesthesia.

Первичные конечные точки

• First-attempt intubation success rate [Срок оценки: During the intubation procedure]

Вторичные конечные точки (8)

• Intubation time [Срок оценки: During the intubation procedure]
• Number of intubation attempts [Срок оценки: During the intubation procedure]
• Incidence of hypoxemia [Срок оценки: During the intubation procedure]
• Incidence of airway-related complications [Срок оценки: During and immediately after the intubation procedure]
• Peri-intubation heart rate [Срок оценки: From baseline before induction to 2 minutes after successful tracheal intubation]
• Peri-intubation oxygen saturation [Срок оценки: From baseline before induction to 2 minutes after successful tracheal intubation]
• Peri-intubation systolic blood pressure [Срок оценки: From baseline before induction to 2 minutes after successful tracheal intubation]
• Peri-intubation diastolic blood pressure [Срок оценки: From baseline before induction to 2 minutes after successful tracheal intubation]

Критерии участия

Критерии включения

• Age 18 to 65 years, inclusive. American Society of Anesthesiologists (ASA) physical status I to III. Scheduled for surgery under general anesthesia requiring endotracheal intubation.

The participant or legally authorized representative is fully informed of the purpose, methods, potential risks, and possible benefits of the study and provides written informed consent.

Критерии исключения

• Anticipated severe difficulty with mask ventilation, such as severe obesity (BMI > 35 kg/m²) with obstructive sleep apnea syndrome, history of neck radiotherapy, craniofacial malformation, or other conditions judged by the attending anesthesiologist to confer high risk for mask ventilation, and patients requiring awake tracheal intubation.

Cervical spine instability, cervical trauma, rheumatoid arthritis involving the cervical spine, ankylosing spondylitis, or any condition requiring absolute cervical immobilization during the procedure.

Significant airway involvement identified preoperatively, including imaging evidence of tracheal narrowing with minimal diameter < 5 mm, severe tracheal compression, displacement or collapse, stridor at rest or after activity, vocal cord paralysis with dyspnea, giant thyroid mass with orthopnea, or other oral, pharyngeal, or laryngeal tumor, edema, stenosis, abscess, or severe upper airway anatomical abnormality affecting glottic exposure or endotracheal tube passage.

High risk of reflux and aspiration. Severe cardiovascular disease, severe respiratory disease, severe hepatic or renal dysfunction, severe coagulation disorder, frailty, pregnancy or breastfeeding, or known allergy.

Any other condition making the patient unsuitable for participation in the study, such as psychiatric illness, communication disorder, or poor compliance.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Guangzhou University of Chinese Medicine — Гуанчжоу

Идентификаторы

NCT: NCT07699653 · GZUCM1-2026-06 · K-2025-214

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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