Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)

• ClinicalTrials.gov Identifier: NCT05989880
• Recruitment Status: Recruiting
• First Posted: August 14, 2023
• Last Update Posted: May 9, 2024
• Sponsor: The University of Texas Health Science Center, Houston
• Information provided by (Responsible Party): Lauren Nakazawa, The University of Texas Health Science Center, Houston

Tracking Information

• First Submitted Date: July 24, 2023
• First Posted Date: August 14, 2023
• Last Update Posted Date: May 9, 2024
• Actual Study Start Date: September 19, 2023
• Estimated Primary Completion Date: October 2, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 9, 2023)

Intubation success rate [ Time Frame: at the time of intubation ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 9, 2023)

• Number of insertion attempts required to achieve effective oxygenation and ventilation [ Time Frame: at the time of intubation ]
• Time to insertion [ Time Frame: at the time of intubation ]
  This is measured by the time from opening the mouth to the time of end tidal CO2 on capnography
• Subjective ease of insertion of the airway device [ Time Frame: at the time of intubation ]
• Safety of the SafeLM as an SGA [ Time Frame: at the time of intubation ]
  This will be assessed by the number of adverse events such as airway obstruction, aspiration, and hypoxia.
• Safety of the SafeLM as a conduit for intubation [ Time Frame: at the time of intubation ]
  This will be assessed by the number of adverse events such as esophageal intubation, bronchial intubation, and hypoxia during the intubation process.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)
• Official Title: Pilot Feasibility Trial of the SafeLM Supraglottic Airway
• Brief 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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.
• 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.

Study Arms

• Experimental: SafeLM as a supraglottic airway device with video capability
  Intervention: Device: SafeLM as a supraglottic airway device with video capability
• Experimental: SafeLM as a supraglottic airway device without video capability
  Intervention: Device: SafeLM as a supraglottic airway device without video capability
• Experimental: SafeLM as a conduit for intubation using an endotracheal tube with video capability
  Intervention: Device: SafeLM as a conduit for intubation using an endotracheal tube with video capability
• Experimental: SafeLM as a conduit for intubation using a bougie with video capability
  Intervention: Device: SafeLM as a conduit for intubation using a bougie with video capability

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 9, 2023): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2, 2024
• Estimated Primary Completion Date: October 2, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Lauren M Nakazawa, MD; 713-500-6775; Lauren.M.Nakazawa@uth.tmc.edu

Contact: Carlos Artime, MD; 713-500-6171; Carlos.Artime@uth.tmc.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05989880
• Other Study ID Numbers: HSC-MS-23-0537
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Lauren Nakazawa, The University of Texas Health Science Center, Houston
• Original Responsible Party: Same as current
• Current Study Sponsor: The University of Texas Health Science Center, Houston
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: The University of Texas Health Science Center, Houston
• Verification Date: May 2024