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Recruiting NCT05989880

Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)

No phase Interventional Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SafeLM as a supraglottic airway device with video capability, SafeLM as a supraglottic airway device without video capability, 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.
Who it may be relevant to
Registry conditions: Anesthesia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Pilot Feasibility Trial of the SafeLM Supraglottic Airway

Overview

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

Interventions

  • 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 oxi
  • 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-tida
  • 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 int
  • 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

Primary outcome measures

  • Intubation success rate [Time frame: at the time of intubation]
Secondary outcome measures (5)
  • 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]
  • 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]
  • Safety of the SafeLM as a conduit for intubation [Time frame: at the time of intubation]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT05989880 · HSC-MS-23-0537

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗