Меню
Идёт набор NCT07493356

Difficult Airway Prediction by Integrating STOP-BANG Criteria

— Наблюдательное Ventilatory Defect Intubation; Difficult or Failed

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Ventilatory Defect, Intubation; Difficult or Failed. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Пакистан
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Enhancing Difficult Airway Prediction in Obese Patients: Integrating STOP-BANG With Additional Airway Assessment Tools

Обзор

This study is being done to determine the diagnostic accuracy of the STOP-BANG questionnaire in predicting difficult mask ventilation and intubation among obese patients. During the preoperative assessment, eligible participants will be enrolled in the study. The modified Mallampati score, thyromental distance, mouth opening, and upper lip bite tests will be performed along with STOP-Bang scores. Later in the operating room, general anesthesia will be given, and bag-mask ventilation and intubation grade will be assessed and recorded. A correlation will be assessed between the difficult airway assessment findings, along with the STOP-BANG score and the bas-mask difficulty scores and intubation grades.

Подробное описание

After approval of the Ethical Review Committee (ERC), the study will commence. Participants will be selected from the scheduled elective surgical lists of all surgical departments. Written informed consent will be acquired from all study participants. The resident will document demographic variables (age, height, weight, and gender) and STOP-Bang scores during the pre-anesthesia assessment for eligible participants. A STOP-Bang score of ≥ 3 will suggest a higher risk for difficult airway, whereas a score of \< 3 will suggest a lower risk. Anesthesia residents under the supervision of a consultant anesthesiologist will record intraoperative observations on a study form. A qualified anesthesia provider performing bag-mask ventilation must have at least three years of anesthesia experience. The primary investigator will gather the questionnaire and intraoperative data form from the trained anesthesiologist. The anesthesiologist managing the airway will be unaware of the STOP-Bang score. Standard monitoring (ECG, non-invasive blood pressure, and peripheral oxygen saturation) will be attached, and baseline readings will be recorded. Pre-oxygenation will be performed for three minutes. Anesthesia will be induced with nalbuphine 100 micrograms/kg and propofol 2 mg/kg until the patient becomes unresponsive to verbal communication; atracurium 0.6 mg/kg will be given after assessing ventilation. Mask ventilation will be carried out for three minutes with the patient's head in the sniffing position. The supervising consultant will decide when to intervene if the primary anesthetist is unable to mask ventilate the patient.

Following three minutes of mask ventilation, the trachea will be intubated using a Macintosh laryngoscope. The endotracheal tube's correct position will be confirmed by monitoring a persistent end-tidal CO₂ waveform, visible chest rise, and bilateral chest auscultation.

Первичные конечные точки

  • Adequate Bag-Mask Ventilation [Срок оценки: Only once, after giving general anesthesia but before an endotracheal tube is put in the trachea]
  • Difficult Tracheal Intubation [Срок оценки: Only once, after giving general anesthesia and 3-minute bag-mask ventilation for adequate muscle relaxation effect, then direct laryngoscopy will be performed to put the endotracheal tube in the trachea]

Критерии участия

Критерии включения

  • Male \& Female aged 18-60 years.
  • Body mass index 30 or more
  • American Society of Anesthesiologists (ASA) status II-III.
  • Scheduled for elective surgery under general anesthesia with endotracheal intubation.

Критерии исключения

  • Patients' refusal to participate.
  • American Society of Anesthesiologists (ASA) IV \& V.
  • Neuromuscular diseases or facial abnormalities.
  • Cardiothoracic, head and neck, or emergency surgery.
  • Previously diagnosed with OSA (by polysomnography) will be excluded.
  • Any airway-related anatomical deformity (e.g., Down's syndrome).
  • History of radiation exposure.
  • Patient with mouth opening <2 fingers

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Пакистан · 1 центр
  • Sindh Institute of Urology and Transplantation — Karachi

Идентификаторы

NCT: NCT07493356 · SIUT-ERC-2025/A-587

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗