LMA I-Gel Versus LMA Protector During Minor Urological Procedures Under General Anesthesia in Adult Patients

Официальное название

Laryngeal Mask Airway I-Gel and Laryngeal Mask Airway Protector for Minor Urological Procedures Under General Anesthesia in Adult Patients: A Randomized Comparative Study

Обзор

This will be a randomized comparative study comparing the two supraglottic devices i-gel and Protector, intraoperatively, during minor urological procedures under general anesthesia in adult patient.

Подробное описание

This randomized comparative study aims to evaluate the effectiveness, safety, and unwanted effects of two laryngeal mask airway devices, the iGel and the Protector. The study will involve adult patients during minor urological procedures under general anesthesia. Participants will be divided into two groups: in one group will be inserted the iGel laryngeal mask airway, while in the other group will be inserted the Protector laryngeal mask airway.

Вмешательства

• Устройство LMA igel
  adults allocated to the LMA igel group, an LMA igel device will be inserted intraoperatively
• Устройство LMA protector
  adults allocated to the LMA protector group, an LMA protector device will be inserted intraoperatively

Первичные конечные точки

• Evaluation of the airway sealing pressure of the Laryngeal Mask Airway (LMA) in neutral, extended, and extended-rotated head positions [Срок оценки: Leak pressure will be measured in cmH2O within 60 seconds after successful placement: first in the neutral position, second in the extended position, and third in the extended rotated head position]

Вторичные конечные точки (4)

• Success rate of each device for patients with a potential difficult airway according to the Simplified Airway Index [Срок оценки: The patients airway will be evaluated 24 hours before surgery based on the Simplified Airway Index for a potential difficult intubation]
• The time required for successful placement of the device [Срок оценки: Measured from the moment the clinician picks up the LMA device after induction of general anesthesia until the appearance of the first capnography waveform on the monitor with a maximum duration of 60 seconds per attempt and up to three attempts allowed]
• Number of attempts to successfully place a nasogastric tube through the specially designed channels of the laryngeal mask [Срок оценки: Each attempt, from the moment the clinician picks up the nasogastric tube, will have a time frame of 5 seconds. If the nasogastric tube is not placed within 5 seconds, the attempt will be considered a failure]
• Documentation of adverse events after the exertion [Срок оценки: Immediately after the exertion]

Критерии участия

Критерии включения

• ASA I-II
• Patients older than 18 years
• Procedures in supine and lithotomy position

Критерии исключения

• Tumors or anatomical anomalies of the upper airway
• Known history of difficult intubation
• Limited mouth opening less than 2cm
• Decreased compliance of the lungs or the thoracic cage
• Need of mechanical ventilation after the surgery

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Греция · 2 центра

• SismanoglioGH — Athens
• SismanoglioGH — Athens

Идентификаторы

NCT: NCT06825910 · 19242/29.08.24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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