Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05989880
NA

Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)

Sponsor: The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

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

Official title: Pilot Feasibility Trial of the SafeLM Supraglottic Airway

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-09-19

Completion Date

2025-12-02

Last Updated

2024-12-10

Healthy Volunteers

No

Conditions

Interventions

DEVICE

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 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.

DEVICE

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-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.

DEVICE

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 into the trachea, and the position will be confirmed by end-tidal carbon dioxide (EtCO2) detection and chest auscultation. The cuff of the endotracheal tube will be inflated, and mechanical ventilation will be resumed. The SafeLM device will be removed, and the position of the endotracheal tube will be confirmed once again.

DEVICE

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 the device.The SafeLM device will be removed, and an appropriately sized endotracheal tube will be advanced into the trachea. If a bougie is not able to be inserted into the tracheal under direct visualization, direct insertion of an endotracheal tube into the trachea will be attempted, followed by flexible scope intubation.

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States