Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)

NCT05989880 | Recruiting FDA Device

• 1 other identifier: HSC-MS-23-0537
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of insertion attempts required to achieve effective oxygenation and ventilation

  at the time of intubation

• Time to insertion

  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

  at the time of intubation

• Safety of the SafeLM as a conduit for intubation

  at the time of intubation

Study Arms (4)

SafeLM as a supraglottic airway device with video capability

EXPERIMENTAL

Device: SafeLM as a supraglottic airway device with video capability

SafeLM as a supraglottic airway device without video capability

EXPERIMENTAL

Device: SafeLM as a supraglottic airway device without video capability

SafeLM as a conduit for intubation using an endotracheal tube with video capability

EXPERIMENTAL

Device: SafeLM as a conduit for intubation using an endotracheal tube with video capability

SafeLM as a conduit for intubation using a bougie with video capability

EXPERIMENTAL

Device: SafeLM as a conduit for intubation using a bougie with video capability

Interventions

SafeLM as a supraglottic airway device with video capability DEVICE

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 with video capability

SafeLM as a supraglottic airway device without video capability DEVICE

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 supraglottic airway device without video capability

SafeLM as a conduit for intubation using an endotracheal tube with video capability DEVICE

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 an endotracheal tube with video capability

SafeLM as a conduit for intubation using a bougie with video capability DEVICE

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.

SafeLM as a conduit for intubation using a bougie with video capability

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective surgery requiring general anesthesia and airway management using a supraglottic airway device or endotracheal intubation

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Study Officials

• Lauren M Nakazawa, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren M Nakazawa, MD

CONTACT

713-500-6775; Lauren.M.Nakazawa@uth.tmc.edu

Carlos Artime, MD

CONTACT

713-500-6171; Carlos.Artime@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 14, 2023
• Study Start: September 19, 2023
• Primary Completion: October 2, 2025
• Study Completion: December 2, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)