- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07668297
Correlation of Neck Dimensions of Airway Evaluation
Correlation of Thyromental Distance And Mandibular Triangle Perpendicular Length With Incisor Vallecular Distance In Adult Pre-Surgical Patients: An Observational Study
Обзор исследования
Статус
Подробное описание
Preoperative evaluation of the upper airway is vital to the success, safety, and quality of airway access. The evaluation primarily aims to anticipate the course of direct laryngoscopy and intubation (DLI) of the trachea. While assessment of mouth opening, neck extension, and dentition forms the preliminary step of knowing whether DLI is feasible; there are certain other parameters whose evaluation facilitates understanding as to how the actual DLI will turn out. Among the secondary parameters, the linear thyromental distance (TMD) is an important measure that determines how the direct laryngoscopy aspect of conducting DLI will go - in terms of ease-of-laryngoscopy to gain the desired visual access to the view to the vocal cords. The ease of laryngoscopy involves as to how the laryngoscope blade would be able to displace tongue to one side, create forward space enhancement, and reach the vallecula at the base of the tongue; before lifting the epiglottis to view the cords. Though in use for over 4 decades, the TMD suffers from weakness, including, low sensitivity and specificity, not relating to the actual and direct teeth vallecular distance, and getting confounded by neck dimensions (thickness, length), state of dentition, and the tongue size.
The present study is built on the premise that it's the mandibular space to which the tongue is displaced at the time of DLI, the bony mandibular space is more exclusive of the confounders, and that the teeth (lower incisors) vallecular distance represent the actual distance that needs to be predicted.
The present study aims to evaluate TMD and mandibular triangle perpendicular length (MTPL); to know which correlates better with the incisor vallecula distance (IVD). Based on the direction and strength of the correlation measure, a multiple regression equation can then be created to first predict the IVD with external linear measure, and second, based on IVD length prediction, the appropriate laryngoscope blade size can be ascertained.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Amitabh Dutta, MD
- Номер телефона: 00919810848064
- Электронная почта: duttaamitabh@yahoo.co.in
Места учебы
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, Индия, 110060
- Рекрутинг
- Sir Ganga Ram Hospital
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Контакт:
- Amitabh Dutta, MBBS, MD, PGDHR
- Номер телефона: 9810848064
- Электронная почта: duttaamitabh@yahoo.co.in
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Age 18-65 years
- Males and females
- ASA (American Society of Anaesthesiologists) physical status I and II
- Patients scheduled for elective surgery with controlled ventilation through orotracheal tube conduit
Exclusion Criteria:
- Smokers (those who have smoked ≥100 cigarettes in their lifetime), chewing tobacco dependence or substance abuse
- Submucous fibrosis: progressive fibrosis of the submucosal tissue leading to rigidity, relative trismus, and progressive decrease of mouth opening
- Anticipated difficult airway
- Patients requiring intubation with MacIntosh blade #4 or #5
Dental issues:
- missing tooth (upper/lower incisors, upper/lower premolar)
- crowded dentition: - irregular, misaligned, or overlapping teeth within a relatively small oral cavity
presence of artificial teeth and/or dental implants
• Mandible/mandibular structure related issues:
- Retrognathia: - posterior displacement of the mandible relative to the maxilla or cranial base
- Prognathia: - anterior displacement of the mandible relative to the maxilla or cranial base
- Emergency Surgery
- Those requiring urgent rapid-sequence intubation due to the presence of a full-stomach status secondary to gastro-esophageal reflux disease, diaphragmatic hernia, among others.
- Refusal to informed consent
Учебный план
Как устроено исследование?
Детали дизайна
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Correlation of thyromental distance (TMD) and mandibular triangle perpendicular length (MTPL) with incisor vallecular distance (IVD)
Временное ограничение: From entry into preoperative area (0 minutes) to time patient is shifted to operating room ( 10-minutes)
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In all patients thyromental distance (TMD) and mandibular triangle perpendicular length (MTPL) will be measured.
TMD will be measured as a straight line distance between the bony mentum (tip of the chin) and the superior thyroid notch (upper border of the thyroid cartilage).
MTPL will be measured as the perpendicular of the mandibular triangle formed by joining the mental protuberence and point at angle of mandible on either side.
During direct larygngosocpoy when the tip of the laryngoscope blade lies on the vallecula, the distance between the laryngoscope blade tip and the point of laryngoscope blade flange overlying the lower incisors will be measured.
A correlation between TMD and MTPL with IVD if any will be established.
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From entry into preoperative area (0 minutes) to time patient is shifted to operating room ( 10-minutes)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Correlation of incisor vallecular distance (IVD), mandibular triangle perpendicular length (MTPL), and thyromental distance (TMD) with Macintosh blade (MCB) size#3 length
Временное ограничение: From induction of anaesthesia (0 minutes) to insertion of endotracheal tube ( 10-minutes)
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Macintosh blade size # 3 length will be determined by measuring the linear distance between the tip of the blade and the point where the concave surface of the blade flange joins the heel of the the laryngoscope blade.
A correlation between IVD, MTPL, and TMD with Macintosh blade size # 3 length if any will be established
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From induction of anaesthesia (0 minutes) to insertion of endotracheal tube ( 10-minutes)
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Cormack and Lehane score
Временное ограничение: From induction of anaesthesia (0 minutes) to insertion of endotracheal tube ( 10-minutes)
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The grade view to the glottic-opening upon direct laryngoscopy will be done using the 4-point Cormack-Lehane grading system (grade 1: entire glottic opening is seen; grade 2: anterior larynx not visualised, only posterior laryngeal aperture is seen; grade 3: only tip of epiglottis is seen; grade 4: neither glottis or epiglottis is visible, only soft palate is seen)
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From induction of anaesthesia (0 minutes) to insertion of endotracheal tube ( 10-minutes)
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Amitabh Dutta, MD, Sir Ganga Ram Hospital, New Delhi-110060, India
- Главный следователь: Paridhi Saboo, MBBS, Sir Ganga Ram Hospital, New Delhi-110060, India
- Директор по исследованиям: Nitin Sethi, DNB, Sir Ganga Ram Hospital, New Delhi-110060, India
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
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
Ключевые слова
Другие идентификационные номера исследования
- EC/06/26/2981
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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