Assessing the SafeLM Supraglottic Airway for Anesthesia
Pilot Feasibility Trial of the SafeLM Supraglottic Airway
This study tests if the SafeLM supraglottic airway device can safely help manage breathing during elective surgeries with general anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05989880 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults undergoing elective surgery that requires general anesthesia and airway management.
Not a fit: Patients with known or suspected difficult airway management or significant respiratory pathology may not benefit from this study.
Why it matters
Potential benefit: If successful, this could enhance airway management techniques, improving patient safety and outcomes during anesthesia.
How similar studies have performed: While this approach is innovative, similar studies on supraglottic airway devices have shown varying degrees of success, indicating potential but also uncertainty.
Eligibility criteria
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 this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.