Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)

The University of Texas System (UT)

Status: Enrolling

Conditions: Anesthesia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05989880

HSC-MS-23-0537

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

SafeLM as a supraglottic airway device with video capability

Experimental group

Treatment:

Device: SafeLM as a supraglottic airway device with video capability

SafeLM as a supraglottic airway device without video capability

Experimental group

Treatment:

Device: SafeLM as a supraglottic airway device without video capability

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

Experimental group

Treatment:

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 group

Treatment:

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