60 Participants Needed

SafeLM Device for Anesthesia

LM
CA
Overseen ByCarlos Artime, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

LM

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

Elective surgery requiring general anesthesia and airway management using a supraglottic airway device or endotracheal intubation

Exclusion Criteria

Pregnancy
You cannot have a breathing tube inserted through your mouth.
Known or suspected full stomach or other risk factors for aspiration
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intubation procedure

1 week

Treatment Details

Interventions

  • SafeLM without video capability
  • SafeLM with video capability
Trial Overview The study tests the SafeLM device's effectiveness as both an airway tool and a guide for intubation with/without video assistance. It explores if SafeLM can help doctors see better when placing breathing tubes in patients under anesthesia.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: SafeLM as a supraglottic airway device without video capabilityExperimental Treatment1 Intervention
Group II: SafeLM as a supraglottic airway device with video capabilityExperimental Treatment1 Intervention
Group III: SafeLM as a conduit for intubation using an endotracheal tube with video capabilityExperimental Treatment1 Intervention
Group IV: SafeLM as a conduit for intubation using a bougie with video capabilityExperimental Treatment1 Intervention

SafeLM without video capability is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as SafeLM for:
  • Airway management during general anesthesia
  • Emergency airway management
🇪🇺
Approved in European Union as SafeLM for:
  • 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

Trials
974
Recruited
361,000+

Findings from Research

Supraglottic airway devices (SGAs) are advantageous for outpatient anesthesia as they require lower doses of anesthetics, rarely need neuromuscular blockers, and are associated with less airway morbidity compared to endotracheal intubation.
However, SGAs have limitations, such as incomplete protection against aspiration and challenges in delivering positive pressure ventilation, which newer variants aim to improve, especially for specific patient populations and procedures.
Supraglottic airway devices in the ambulatory setting.Luba, K., Cutter, TW.[2022]
In a study of 834 morbidly obese patients, a neck circumference (NC) of 49.5 cm or greater was identified as a strong predictor for the need for a supraglottic airway device (SGA) to achieve effective ventilation, indicating that NC is a critical factor in managing difficult mask ventilation.
The use of SGAs as a first-line device in morbidly obese patients can enhance safety during anesthesia induction, especially for those with a high body mass index (BMI) and significant neck circumference, as these factors were associated with increased difficulty in maintaining adequate oxygen saturation.
The supraglottic airway device as first line of management in anticipated difficult mask ventilation in the morbidly obese.Sinha, A., Jayaraman, L., Punhani, D.[2022]
In a study involving 240 children, the LMA Supreme™ demonstrated the highest first attempt success rate (100%) and was rated the easiest to insert, compared to the Air-Q® (90%) and Ambu® Aura-i™ (91%).
All tested supraglottic airway devices had airway leak pressures below the target of 20 cmH2O, but they still allowed for positive pressure ventilation, with the LMA Supreme™ showing the best performance overall.
Pediatric supraglottic airway devices in clinical practice: A prospective observational study.Kleine-Brueggeney, M., Gottfried, A., Nabecker, S., et al.[2022]

References

Supraglottic airway devices in the ambulatory setting. [2022]
The supraglottic airway device as first line of management in anticipated difficult mask ventilation in the morbidly obese. [2022]
Pediatric supraglottic airway devices in clinical practice: A prospective observational study. [2022]
Comparison of clinical performance of Ambu® AuraGain™ and BlockBuster® in anaesthetised preschool children-A randomised controlled trial. [2023]
[Interdisciplinary consensus statement on alternative airway management with supraglottic airway devices in pediatric emergency medicine: Laryngeal mask is state of the art]. [2018]
Features of new vision-incorporated third-generation video laryngeal mask airways. [2022]
A critique of elective pediatric supraglottic airway devices. [2022]
Preliminary evaluation of SaCoVLM™ video laryngeal mask airway in airway management for general anesthesia. [2022]
The clinical effectiveness of the streamlined liner of pharyngeal airway (SLIPA) compared with the laryngeal mask airway ProSeal during general anesthesia. [2022]
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