SafeLM Device for Anesthesia
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the SafeLM Device for Anesthesia treatment?
Research shows that supraglottic airway devices (SGAs), like the SafeLM, are effective in managing airways during anesthesia, especially in outpatient settings. They are easier to tolerate, require less anesthetic, and lead to quicker recovery compared to traditional methods, although they may not fully protect against stomach content aspiration.12345
Is the SafeLM Device for Anesthesia generally safe for use in humans?
The SafeLM Device, a type of supraglottic airway device (SGA), is considered to have certain safety advantages over traditional methods like endotracheal intubation, such as lower airway morbidity and faster recovery. However, safety data for newer devices like the SafeLM is often based on extended use rather than high-quality studies, so claims of safety should be interpreted cautiously.12567
What makes the SafeLM device unique compared to other airway management treatments?
The SafeLM device is unique because it incorporates a videoscope for direct vision during insertion, which can improve placement accuracy and safety compared to traditional supraglottic airway devices that are inserted blindly. This feature allows for corrective maneuvers and the potential for easier insertion of a gastric tube or endotracheal intubation if needed.13689
What is the purpose of this trial?
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
Research Team
Lauren M Nakazawa, MD
Principal Investigator
The University of Texas Health Science Center, Houston
Eligibility Criteria
This trial is for adults needing general anesthesia and airway management during elective surgery. Candidates should not be pregnant, have a BMI over 40, known difficult airways, significant respiratory issues like severe sleep apnea or COPD, history of upper airway surgery, or major risk of aspiration.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo procedures 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
Follow-up
Participants are monitored for safety and effectiveness after the intubation procedure
Treatment Details
Interventions
- SafeLM without video capability
- SafeLM with video capability
SafeLM without video capability is already approved in United States, European Union for the following indications:
- Airway management during general anesthesia
- Emergency airway management
- Airway management during general anesthesia
- Emergency airway management
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor