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NCT Number: NCT05989880

Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)

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

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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 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 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 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of insertion attempts required to achieve effective oxygenation and ventilation

    Time frame: at the time of intubation

  2. 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

  3. Subjective ease of insertion of the airway device

    Time frame: at the time of intubation

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carlos Artime, MD

CONTACT

[email protected]

713-500-6171

Lauren M Nakazawa, MD

CONTACT

[email protected]

713-500-6775

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Pilot Feasibility Trial of the SafeLM Supraglottic Airway

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2023
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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