Pilot Feasibility Trial of the SafeLM Supraglottic Airway
The University of Texas Health Science Center, Houston
Summary
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * elective surgery requiring general anesthesia and airway management using a supraglottic airway device or endotracheal intubation Exclusion Criteria: * 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…
Interventions
- DeviceSafeLM 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 oximetry, and clinical signs of effective ventilation. Leak and cuff pressure will be assessed. The device will be removed at the end of the surgical procedure or if there are any signs of device malfunction, airway obstruction, or inadequate ventilation.
- DeviceSafeLM 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-tidal CO2, pulse oximetry, and clinical signs of effective ventilation. Leak and cuff pressure will be assessed. The video capability of the device will be used to assess the accuracy of placement after the fact. The device will be removed at the end of the surgical procedure or if there are any signs of device malfunction, airway obstruction, or inadequate ventilation.
- DeviceSafeLM as a conduit for intubation using an endotracheal tube with video capability
Location
- The University of Texas Health Science Center at HoustonHouston, Texas