Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)

Pilot Feasibility Trial of the SafeLM Supraglottic Airway

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

Study Overview

• Status: Recruiting
• Conditions: Anesthesia
• Intervention / Treatment: Device: SafeLM as a supraglottic airway device with video capability; Device: SafeLM as a supraglottic airway device without video capability; Device: SafeLM as a conduit for intubation using an endotracheal tube with video capability; Device: SafeLM as a conduit for intubation using a bougie with video capability

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren M Nakazawa, MD; Phone Number: 713-500-6775; Email: Lauren.M.Nakazawa@uth.tmc.edu
• Study Contact Backup: Name: Carlos Artime, MD; Phone Number: 713-500-6171; Email: Carlos.Artime@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Lauren M Nakazawa, MD; Phone Number: 713-500-6775; Email: Lauren.M.Nakazawa@uth.tmc.edu
      • Contact: Carlos Artime, MD; Phone Number: 713-500-6171; Email: Carlos.Artime@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SafeLM as a supraglottic airway device with video capability	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.
Experimental: SafeLM as a supraglottic airway device without video capability	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.
Experimental: SafeLM as a conduit for intubation using an endotracheal tube with video capability	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.
Experimental: SafeLM as a conduit for intubation using a bougie with video capability	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of insertion attempts required to achieve effective oxygenation and ventilation		at the time of intubation
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
Subjective ease of insertion of the airway device		at the time of intubation
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
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Lauren M Nakazawa, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2023
• Primary Completion (Estimated): October 2, 2024
• Study Completion (Estimated): December 2, 2024

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HSC-MS-23-0537

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No