Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)

Anesthesia Clinical Trial

Official title:

Pilot Feasibility Trial of the SafeLM Supraglottic Airway

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05989880
• Other study ID #: HSC-MS-23-0537
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: December 2, 2024

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Lauren M Nakazawa, MD
• Phone: 713-500-6775
• Email: Lauren.M.Nakazawa[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2, 2024
• Est. primary completion date: October 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 for the use of neuromuscular blocking agents

• history of significant gastroesophageal reflux disease (GERD)

• Vulnerable populations (cognitively impaired persons, prisoners)

Related Conditions & MeSH terms

• Anesthesia

Intervention

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.
• 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.
• 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.
• 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

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation success rate	This is assessed by the ability of the SafeLM to achieve adequate oxygenation and ventilation via the respective procedure once the airway device is in place.	at the time of intubation
Secondary	Number of insertion attempts required to achieve effective oxygenation and ventilation		at the time of intubation
Secondary	Time to insertion	This is measured by the time from opening the mouth to the time of end tidal CO2 on capnography	at the time of intubation
Secondary	Subjective ease of insertion of the airway device		at the time of intubation
Secondary	Safety of the SafeLM as an SGA	This will be assessed by the number of adverse events such as airway obstruction, aspiration, and hypoxia.	at the time of intubation
Secondary	Safety of the SafeLM as a conduit for intubation	This will be assessed by the number of adverse events such as esophageal intubation, bronchial intubation, and hypoxia during the intubation process.	at the time of intubation