Comparison of Gastric Volume in I-gel and ProSeal Laryngeal Mask Airways
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
- В протоколе указаны: i jel LMA, proseal LMA.
- Кому может быть актуально
- Состояния в реестре: Nausea and Vomiting, Postoperative, Sore-throat. Базовые параметры: 18 лет — 79 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
- Turkey (Türkiye)
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Comparison of Gastric Insufflation Volume by Ultrasound Using I-gel and ProSeal Laryngeal Mask Airways in Patients Undergoing Urological Surgery
Обзор
This study was planned to compare the gastric insufflation volume between i jel and ProSeal laryngeal mask airway (LMA) and its relationship with the oropharyngeal sealing pressure and the incidence of postoperative complications in patients undergoing urological surgery.
Подробное описание
Supraglottic airway devices (SADs) are widely used in both elective and emergency surgeries, resuscitation, and difficult airway management. Compared to endotracheal intubation, they are less invasive, require lower doses of anaesthetic agents, and cause less haemodynamic instability. Among supraglottic airway devices, the I-gel differs from other SADs in that it does not have an inflatable cuff; instead, it features a soft structure made of a transparent thermoplastic elastomer that mimics a cuff. In addition, it has a gastric channel alongside the airway tube that allows for gastric aspiration.
ProSeal LMA is one of the most commonly used SADs in clinical practice. It was developed in the early 2000s as a modification of the classic LMA and includes an inflatable cuff. Like the I-gel, it also features a gastric drainage channel for aspiration.
Aspiration pneumonia is a serious complication of anaesthesia, accounting for approximately 9% of all anaesthesia-related mortality. Traditionally, oropharyngeal leak pressure (OLP) provides information about the potential for gastric insufflation and thus the risk of gastric aspiration. Measurement of the gastric antral cross-sectional area (AGCA) by ultrasound allows for the estimation of gastric volume and helps assess the risk of aspiration.
This study was planned to compare the gastric insufflation volume between i jel and ProSeal LMA and its relationship with the oropharyngeal sealing pressure and the incidence of postoperative complications in patients undergoing urological surgery.
Вмешательства
- Другое i jel LMA
Patients will be inserted i jel laryngeal mask under general anesthesia. - Другое proseal LMA
Patients will be inserted proseal laryngeal mask under general anesthesia.
Первичные конечные точки
- Measurement of oropharyngeal leak pressure (OLP) [Срок оценки: Five minutes after successful LMA placement]
Вторичные конечные точки (4)
- Gastric volume [Срок оценки: 1 minute before induction of anesthesia]
- Gastric volume [Срок оценки: End of the operation, 5 minutes before LMA removal,]
- fiberoptic view grading [Срок оценки: Five minutes after successful LMA placement]
- Complications during i jel and propseal LMA removal (emerge) [Срок оценки: One minute after i jel and propseal LMA removal]
Критерии участия
Критерии включения
- Patients with an ASA (American Society of Anesthesiologists) physical status score of 1 to 3
- undergoing urological surgeries performed with I-gel or ProSeal LMA
Критерии исключения
- Difficult airway
- Clinically significant upper respiratory tract infection
- Pre-existing airway disease
- Pre-existing airway disease
- History of head and neck surgery
- Pregnant patients
- Patients with upper gastrointestinal tract disease
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
Turkey (Türkiye) · 1 центр
- Zeynep Koç — Yenimahalle
Публикации
- Gunasekaran A, Govindaraj K, Gupta SL, Vinayagam S, Mishra SK. Comparison of Gastric Insufflation Volume Between Ambu AuraGain and ProSeal Laryngeal Mask Airway Using Ultrasonography in Patients Undergoing General Anesthesia: A Randomized Controlled Trial. Cureus. 2022 Aug 11;14(8):e27888. doi: 10.7759/cureus.27888. eCollection 2022 Aug. PMID 36110490
- Zhou S, Cao X, Zhou Y, Xu Z, Liu Z. Ultrasound Assessment of Gastric Volume in Parturients After High-Flow Nasal Oxygen Therapy. Anesth Analg. 2023 Jul 1;137(1):176-181. doi: 10.1213/ANE.0000000000006340. Epub 2023 Jan 11. PMID 36630297
- Ye Q, Wu D, Fang W, Wong GTC, Lu Y. Comparison of gastric insufflation using LMA-supreme and I-gel versus tracheal intubation in laparoscopic gynecological surgery by ultrasound: a randomized observational trial. BMC Anesthesiol. 2020 Jun 3;20(1):136. doi: 10.1186/s12871-020-01057-z. PMID 32493213
Идентификаторы
NCT: NCT07138092 · ZeynepKoc006