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NCT05989880NARecruiting

Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)

The University of Texas Health Science Center, Houston

Start Date

9/19/2023

Completion Date

12/2/2025

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

Eligibility Criteria

Age Range: 18 years to No maximum

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)

Interventions

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 an endotracheal tube with video capability

DEVICE

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

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Conditions

Anesthesia

Locations

The University of Texas Health Science Center at Houston

Houston, Texas 77030

United States