Assessing the SafeLM Supraglottic Airway for Anesthesia
Official title: Pilot Feasibility Trial of the SafeLM Supraglottic Airway
Run by The University of Texas Health Science Center, Houston · NCT05989880 · Data updated 2026-11-12
This study tests if the SafeLM supraglottic airway device can safely help manage breathing during elective surgeries with general anesthesia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | September 19, 2023 |
| Main results expected | October 2, 2025 |
| Study ends | December 2, 2025 |
| Registry record updated | December 10, 2024 |
| Trial ID | NCT05989880 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults undergoing elective surgery that requires general anesthesia and airway management.
✕Probably not a fit
Patients with known or suspected difficult airway management or significant respiratory pathology may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the feasibility of the SafeLM supraglottic airway device as a primary airway management tool during elective surgeries requiring general anesthesia. It examines the device's effectiveness both with and without video capability, as well as its use as a conduit for intubation with and without a bougie. The goal is to determine how well the SafeLM can facilitate airway management in a controlled surgical environment.
Why it matters
Potential benefit: If successful, this could enhance airway management techniques, improving patient safety and outcomes during anesthesia.
How similar studies have gone: While this approach is innovative, similar studies on supraglottic airway devices have shown varying degrees of success, indicating potential but also uncertainty.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
The University of Texas Health Science Center at Houston
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Lauren M Nakazawa, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Lauren M Nakazawa, MD
- Email: Lauren.M.Nakazawa@uth.tmc.edu
- Phone: 713-500-6775
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.