Status:
RECRUITING
Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Anesthesia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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
Inclusion
- elective surgery requiring general anesthesia and airway management using a supraglottic airway device or endotracheal intubation
Exclusion
- 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)
Key Trial Info
Start Date :
September 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 2 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05989880
Start Date
September 19 2023
End Date
December 2 2025
Last Update
December 10 2024
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030