Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)
Recruiting now · Not applicable
Conditions studied: Anesthesia
In brief
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
Key facts
- Study ID
- NCT05989880
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 60
- Starts
- 2023-09-19
- Expected to finish
- 2025-12-02
- Last updated by the study team
- 2024-12-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- elective surgery requiring general anesthesia and airway management using a supraglottic airway device or endotracheal intubation
You may not qualify if…
- 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)
Where it is running
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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