Correlation Between Bedside Anatomical Indicators and Lifting Force and Glottic Exposure Under Different Video Laryngoscopy Techniques
This single-center prospective observational study plans to enroll 196 patients undergoing elective general anesthesia. The study aims to investigate the correlation between preoperative bedside anatomical indicators (including modified Mallampati classification, upper lip bite test, mouth opening, head circumference, and thyromental distance) and the peak lifting force applied during video laryngoscopy, as well as the degree of glottic exposure (POGO score). The study will also evaluate the potential benefit of the direct epiglottis elevation technique in specific anatomical subgroups. After anesthesia induction, the same anesthesiologist will perform video laryngoscopy using two distinct techniques in a fixed sequence: the indirect (vallecula) method and the direct (subepiglottic) method. Peak lifting force will be quantitatively measured in real-time using a resistive thin-film pressure sensor attached to the laryngoscope blade. The primary outcomes are the POGO scores and peak lifting forces under both techniques. The secondary outcome includes the change in POGO score (ΔPOGO) between techniques. The study will provide quantitative evidence regarding the "anatomy-force-view" relationship and aid in individualized clinical decision-making for video laryngoscopy intubation.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
This study is a single-center, prospective, observational study. A total of 196 adult patients scheduled for elective surgery under general anesthesia requiring orotracheal intubation will be enrolled. Preoperative bedside anatomical assessment will be performed by a standardized, blinded evaluator. The assessed indicators include mouth opening, thyromental distance, modified Mallampati classification, upper lip bite test, head circumference, and neck circumference. After standard anesthesia induction, video laryngoscopy will be performed by an experienced anesthesiologist. Two techniques will be evaluated in a fixed sequence: (1) Indirect epiglottis elevation (vallecula method): the blade tip is placed in the vallecula to indirectly elevate the epiglottis by lifting the tongue base. (2) Direct epiglottis elevation (subepiglottic method): the blade tip is advanced past the vallecula and placed directly under the laryngeal surface of the epiglottis to actively lift it. A resistive thin-film pressure sensor attached to the video laryngoscope blade will continuously record real-time force data, and the peak lifting force will be extracted for analysis. Glottic exposure will be evaluated using the Percentage of Glottic Opening (POGO) score. Between the two assessments, mask ventilation will be performed for at least 2 minutes to maintain SpO2 ≥ 98%. All procedures and data collection will adhere to the approved protocol by the Ethics Committee of the Second Hospital of Shanxi Medical University (Approval No. [2026] YX No. 172). Statistical analyses will be performed using SPSS 26.0 and R software, including Spearman rank correlation, Kruskal-Wallis test, and multiple linear regression with Bootstrap validation.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Jin
- Номер телефона: +86-18235572836
- Электронная почта: 1806442507@qq.com
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Adult patients aged 18 to 75 years with ASA physical status I to III who are scheduled for elective surgery under general anesthesia requiring orotracheal intubation under video laryngoscopy guidance. Patients with known difficult airway, facial or neck abnormalities affecting landmark palpation, limited mouth opening (< 2.0 cm), or edentulism are excluded.
Описание
Inclusion Criteria:
- - Age 18 to 75 years
- ASA physical status I to III
- Scheduled for orotracheal intubation under video laryngoscopy guidance
- Written informed consent obtained
Exclusion Criteria:
-
Known history of difficult airway or anticipated need for awake intubation
- Facial or neck trauma, burns, or surgical history affecting palpation of anatomical landmarks
- Temporomandibular joint ankylosis or mouth opening < 2.0 cm
- Edentulous patients
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
Patients Undergoing Video Laryngoscopy
Adult patients scheduled for elective general anesthesia requiring orotracheal intubation under video laryngoscopy guidance. All participants will undergo both indirect and direct epiglottis elevation techniques in a fixed sequence. |
Video laryngoscopy blade tip advanced past the vallecula and placed under the laryngeal surface of the epiglottis to directly lift it. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Peak Lifting Force with Direct Epiglottis Elevation
Временное ограничение: Perioperative
|
Peak lifting force (gf) measured by a resistive thin-film pressure sensor attached to the video laryngoscope blade during the direct (subepiglottic) technique. |
Perioperative
|
|
Peak Lifting Force with Indirect Epiglottis Elevation
Временное ограничение: Perioperative
|
Peak lifting force (gf) measured by a resistive thin-film pressure sensor attached to the video laryngoscope blade during the indirect (vallecula) technique. |
Perioperative
|
|
POGO Score with Indirect Epiglottis Elevation
Временное ограничение: Perioperative
|
Percentage of Glottic Opening (POGO) score assessed via video laryngoscopy using the indirect (vallecula) technique. The scale ranges from 0% to 100%, where higher scores indicate better visualization of the glottis (better outcome). |
Perioperative
|
|
POGO Score with Direct Epiglottis Elevation
Временное ограничение: Perioperative
|
Percentage of Glottic Opening (POGO) score assessed via video laryngoscopy using the direct (subepiglottic) technique. The scale ranges from 0% to 100%, where higher scores indicate better visualization of the glottis (better outcome). |
Perioperative
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Delta POGO (ΔPOGO)
Временное ограничение: Perioperative
|
Perioperative
|
|
Incidence of Difficult Glottic Exposure
Временное ограничение: Perioperative
|
Perioperative
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- [2026]YX172
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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