Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)

Официальное название

Pilot Feasibility Trial of the SafeLM Supraglottic Airway

Обзор

The purpose of this study is to assess the feasibility of SafeLM as a primary airway device and as a conduit for intubation with and without the use of a bougie

Вмешательства

• Устройство SafeLM as a supraglottic airway device with video capability
  The device will be inserted using the video capability and used as a primary airway device for the duration of the surgical procedure. Once the device is in place, the cuff will be inflated with the recommended volume of air to ensure an adequate seal around the laryngeal opening. The position of the device will be confirmed by observing the video image of the glottis on the monitor. The adequacy of ventilation and oxygenation will be assessed by monitoring the patient's end-tidal CO2, pulse oxi
• Устройство SafeLM as a supraglottic airway device without video capability
  The device will be blindly inserted without using the video capability and used as a primary airway device for the duration of the surgical procedure. Once the device is in place, the cuff will be inflated with the recommended volume of air to ensure an adequate seal around the laryngeal opening. The position of the device will be confirmed by observing the video image of the glottis on the monitor. The adequacy of ventilation and oxygenation will be assessed by monitoring the patient's end-tida
• Устройство SafeLM as a conduit for intubation using an endotracheal tube with video capability
  The device will be inserted, and an endotracheal tube will be advanced through the device under direct visualization using the video capability of the device. Once the device is in place, the cuff will be inflated with the recommended volume of air to ensure an adequate seal around the laryngeal opening. The endotracheal tube will be introduced through the working channel of the SafeLM under direct visualization using the video capability of the device. The endotracheal tube will be advanced int
• Устройство SafeLM as a conduit for intubation using a bougie with video capability
  The device will be inserted. Once the device is in place, the cuff will be inflated with the recommended volume of air to ensure an adequate seal around the laryngeal opening.The position of the device will be confirmed by observing the video image of the glottis on the monitor. The video camera on the SafeLM will be turned on to visualize the vocal cords.A standard airway bougie will be introduced through the working channel of the SafeLM under direct visualization using the video capability of

Первичные конечные точки

• Intubation success rate [Срок оценки: at the time of intubation]

Вторичные конечные точки (5)

• Number of insertion attempts required to achieve effective oxygenation and ventilation [Срок оценки: at the time of intubation]
• Time to insertion [Срок оценки: at the time of intubation]
• Subjective ease of insertion of the airway device [Срок оценки: at the time of intubation]
• Safety of the SafeLM as an SGA [Срок оценки: at the time of intubation]
• Safety of the SafeLM as a conduit for intubation [Срок оценки: at the time of intubation]

Критерии участия

Критерии включения

• elective surgery requiring general anesthesia and airway management using a supraglottic airway device or endotracheal intubation

Критерии исключения

• pregnancy
• known or suspected difficult airway management
• history of oropharyngeal or upper airway surgery
• known or suspected airway or respiratory pathology, such as significant obstructive sleep apnea or chronic obstructive pulmonary disease (COPD)
• BMI greater than 40 kg/m2
• unable to undergo intubation via the oral route
• known or suspected full stomach or other risk factors for aspiration
• contraindication for the use of neuromuscular blocking agents
• history of significant gastroesophageal reflux disease (GERD)
• Vulnerable populations (cognitively impaired persons, prisoners)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT05989880 · HSC-MS-23-0537

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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