SafeLM Device for Anesthesia

Overseen By Carlos Artime, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Pregnancy, Obesity, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

60 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 5 6 7}

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. ^{1 3 6 8 9}

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

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

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

Group I: SafeLM as a supraglottic airway device without video capability Experimental Treatment 1 Intervention

Group II: SafeLM as a supraglottic airway device with video capability Experimental Treatment 1 Intervention

Group III: SafeLM as a conduit for intubation using an endotracheal tube with video capability Experimental Treatment 1 Intervention

Group IV: SafeLM as a conduit for intubation using a bougie with video capability Experimental Treatment 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric supraglottic airway devices in clinical practice: A prospective observational study. Kleine-Brueggeney, M., Gottfried, A., Nabecker, S., et al.[2022]

The BlockBuster® laryngeal mask airway (LMA) demonstrated a higher oropharyngeal seal pressure (OSP) of 29.08 cm H2O compared to 26.6 cm H2O for the Ambu® AuraGain™, indicating better airway sealing capability in preschool children.

The BlockBuster® LMA also showed a significantly higher first attempt intubation success rate of 80% compared to only 4% for the Ambu® AuraGain™, along with fewer postoperative complications, making it a more effective choice for pediatric airway management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of clinical performance of Ambu® AuraGain™ and BlockBuster® in anaesthetised preschool children-A randomised controlled trial. Gaur, Y., Jaju, R., Paliwal, N., et al.[2023]

The laryngeal mask (LM) is recommended for airway management in pediatric emergencies due to its significantly higher evidence of successful application compared to the laryngeal tube (LT), which lacks sufficient evidence, especially for children under 10 kg.

For effective emergency airway management, SGAs should allow for gastric drainage, and the LM should be available in all pediatric sizes, with regular training for users to ensure proper application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Interdisciplinary consensus statement on alternative airway management with supraglottic airway devices in pediatric emergency medicine: Laryngeal mask is state of the art]. Keil, J., Jung, P., Schiele, A., et al.[2018]

The introduction of two new third-generation supraglottic airway devices (SADs) with integrated videoscopes allows for vision-guided insertion, which can significantly improve placement accuracy compared to traditional methods that often result in sub-optimal placement in 50 to 80% of cases.

These devices not only facilitate correct placement in the hypopharynx but also enable additional procedures like gastric tube insertion and endotracheal intubation, highlighting their versatility and potential safety advantages, although clinical validation is still needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Features of new vision-incorporated third-generation video laryngeal mask airways. Van Zundert, AAJ., Gatt, SP., Van Zundert, TCRV., et al.[2022]

There is a growing variety of supraglottic airway devices (SADs) available for pediatric anesthesia, but high-quality evidence supporting their efficacy is limited, especially compared to established devices like the LMA-Classic and LMA-Proseal.

Safety data for these newer SADs is often based on extended use rather than rigorous studies, making it difficult to assess their safety accurately, particularly for rare complications like aspiration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A critique of elective pediatric supraglottic airway devices. White, MC., Cook, TM., Stoddart, PA.[2022]

The SaCoVLM™ video laryngeal mask airway demonstrated a high first-time insertion success rate of 95% and effectively visualized the laryngeal inlet in all 100 adult patients undergoing general anesthesia.

With a sealing pressure of 34.1 cmH2O and minimal mild complications reported, SaCoVLM™ shows promise as an effective and safe device for airway management during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary evaluation of SaCoVLM™ video laryngeal mask airway in airway management for general anesthesia. Yan, CL., Chen, Y., Sun, P., et al.[2022]

The streamlined liner of the pharynx airway (SLIPA) showed a first insertion success rate of 73.3%, compared to 93.3% for the ProSeal laryngeal mask airway (PLMA), indicating that PLMA may be easier to use during general anesthesia.

Despite the lower success rate, SLIPA had comparable efficacy in terms of lung mechanics and complication rates, but it was associated with a higher incidence of blood stains on the device (40% for SLIPA vs. 6.7% for PLMA), suggesting a potential safety concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical effectiveness of the streamlined liner of pharyngeal airway (SLIPA) compared with the laryngeal mask airway ProSeal during general anesthesia. Choi, YM., Cha, SM., Kang, H., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Supraglottic airway devices in the ambulatory setting. [2022]

2. India pubmed.ncbi.nlm.nih.gov

The supraglottic airway device as first line of management in anticipated difficult mask ventilation in the morbidly obese. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Pediatric supraglottic airway devices in clinical practice: A prospective observational study. [2022]

4. India pubmed.ncbi.nlm.nih.gov

Comparison of clinical performance of Ambu® AuraGain™ and BlockBuster® in anaesthetised preschool children-A randomised controlled trial. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

[Interdisciplinary consensus statement on alternative airway management with supraglottic airway devices in pediatric emergency medicine: Laryngeal mask is state of the art]. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Features of new vision-incorporated third-generation video laryngeal mask airways. [2022]

7. France pubmed.ncbi.nlm.nih.gov

A critique of elective pediatric supraglottic airway devices. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Preliminary evaluation of SaCoVLM™ video laryngeal mask airway in airway management for general anesthesia. [2022]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

The clinical effectiveness of the streamlined liner of pharyngeal airway (SLIPA) compared with the laryngeal mask airway ProSeal during general anesthesia. [2022]