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
Conditions
Anesthesia
Locations
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United States