Actively Recruiting
Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)
Led by The University of Texas Health Science Center, Houston · Updated on 2024-12-10
60
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Elective surgery requiring general anesthesia and airway management using a supraglottic airway device or endotracheal intubation
You will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
L
Lauren M Nakazawa, MD
CONTACT
C
Carlos Artime, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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