Modified Supraglottic Airway Device for Ventilation Therapy Complications

Overseen By Mark Mettler

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Difficult airway, BMI >35, GERD, others

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

Compensation: Varies

Number of Visits: 1

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The proposed A/Z modification of a supraglottic airway (SGA) incorporates an opening in the SGA body that enables access to the endotracheal tube (ETT) through the body of the SGA without the need of using an exchange catheter, thus enabling an ETT to move in the body of the SGA and convert a supraglottic to endotracheal ventilation. In its original form an adaptor made from same material currently used in the endotracheal tubes can make ventilation through the proposed airway device possible in exactly the same manner of a conventional SGA currently used. This adapter also known as the R-piece can be replaced with an ETT. The modification also allows placement of SGA over an existing ETT to convert and endotracheal (ET) to supraglottic (SG) mode of ventilation without the need to use an exchange catheter.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment A/Z Supraglottic airway?

Supraglottic airway devices (SADs) are effective in keeping the airway open for ventilation, with newer designs improving their success rate in difficult cases. They are used successfully in over 90% of patients where other methods fail, showing their reliability in providing ventilation. ^{1 2 3 4 5}

Is the modified supraglottic airway device generally safe for humans?

Supraglottic airway devices are generally safe, with serious complications like aspiration and airway loss being rare and preventable. Mild side effects such as sore throat or hoarseness are more common but usually short-lasting. ^{6 7 8 9 10}

How is the modified supraglottic airway device different from other treatments for ventilation therapy complications?

The modified supraglottic airway device is unique because it incorporates features like drain tubes or compartments to manage regurgitated content, reducing the risk of aspiration compared to earlier devices. This makes it a safer option for maintaining the airway during surgeries where aspiration is a concern. ^{1 2 6 10 11}

Eligibility Criteria

This trial is for adult patients who are scheduled for a general anesthesia procedure that requires an endotracheal tube and muscle relaxation. It's not suitable for individuals with a BMI over 35, acid reflux issues, plans other than general anesthesia, communication barriers like non-English speaking, history of difficult airway management or those needing emergency procedures.

Inclusion Criteria

I am an adult scheduled for surgery with general anesthesia and muscle relaxation.

Exclusion Criteria

My BMI is over 35.

My surgery will not use general anesthesia.

I have had problems with my airway in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Trialing the A/Z concept on an original A/Z modification by a manufacturer on their currently used SGA

During surgical procedures

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

Immediately after intervention

Treatment Details

Interventions

• A/Z Supraglottic airway

Trial Overview The trial is testing a modified supraglottic airway device designed to improve ventilation by allowing direct access to the trachea without additional equipment. This could make it easier to switch between supraglottic and endotracheal ventilation during surgery.

Participant Groups

Group I: A/Z Airway Experimental Treatment 1 Intervention

Patients under general anesthesia for surgical procedures who need airway management for ventilation.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Findings from Research

In a study of 100 patients undergoing elective surgery, both the LMA Proseal (P-LMA) and LMA Supreme (S-LMA) were effective as ventilatory devices, but the S-LMA had a faster insertion time and higher success rate on the first attempt (96% vs. 92%).

The LMA Proseal provided a better oropharyngeal leak pressure (24.04 cmH2O) compared to the LMA Supreme (20.05 cmH2O), indicating a more effective glottic seal, but the S-LMA's ease of use makes it a preferable alternative in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Study of Two Laryngeal Mask Airways: Proseal Laryngeal Mask Airway and Supreme Laryngeal Mask Airway in Anesthetized Paralyzed Adults Undergoing Elective Surgery. Gill, RK., Tarat, A., Pathak, D., et al.[2022]

Second-generation supraglottic airway devices (SADs) have significantly improved the ability to provide effective ventilation during general anesthesia, achieving successful rescue ventilation in over 90% of patients where traditional methods fail.

Despite their advantages, there are still concerns regarding potential airway damage and the risk of pulmonary aspiration, highlighting the importance of careful patient selection and skilled technique in their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supraglottic airway devices. Ramachandran, SK., Kumar, AM.[2022]

Supraglottic airway devices have evolved significantly since the 1980s, proving to be safe and effective for managing pediatric airways, including in difficult cases.

Newer designs of these devices incorporate advanced features that address limitations of older models, enhancing their efficacy in both normal and challenging airway management scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in supraglottic airway devices for the management of difficult airways in children. Huang, AS., Hajduk, J., Jagannathan, N.[2016]

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 of 65 children undergoing spontaneous ventilation supraglottoplasty (SVS) for severe laryngomalacia, only 4.5% required more than an overnight hospital stay, indicating that the procedure is safe with low complication rates.

The majority of patients (78.1%) were able to take adequate oral intake within 4 hours post-surgery, suggesting a quick recovery and that postoperative intubation or intensive care monitoring may not be necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative management following supraglottoplasty for severe laryngomalacia. Fordham, MT., Potter, SM., White, DR.[2022]

Supraglottic airway devices (SADs) are increasingly used in various medical settings for airway management, serving as alternatives to traditional methods like face mask ventilation and endotracheal intubation.

Serious complications from SADs, such as aspiration and loss of airway, are rare and preventable, emphasizing the importance of operator experience and careful patient selection for safe and effective use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supraglottic airway devices: indications, contraindications and management. Gordon, J., Cooper, RM., Parotto, M.[2019]

In a study of 14,480 patients undergoing general anesthesia, only 0.5% experienced difficult ventilation with a supraglottic airway device, indicating that these devices are generally effective for maintaining ventilation.

Four key risk factors for difficult ventilation were identified: male sex, age over 45, short thyromental distance, and limited neck movement, which can help clinicians anticipate and manage potential challenges during anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of and risk factors for difficult ventilation via a supraglottic airway device in a population of 14,480 patients from South-East Asia. Saito, T., Liu, W., Chew, ST., et al.[2016]

In a study of 15,795 patients using the laryngeal mask airway (uLMA™), the failure rate was found to be low at 1.1%, but significant respiratory complications occurred in over 60% of those cases, highlighting the importance of monitoring during use.

Four key risk factors for uLMA™ failure were identified: surgical table rotation, male sex, poor dentition, and increased body mass index, which can help clinicians assess and manage potential complications more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors and clinical outcomes from failed Laryngeal Mask Airway Unique™: a study of 15,795 patients. Ramachandran, SK., Mathis, MR., Tremper, KK., et al.[2022]

A study analyzing 102 adverse events related to the removal of airway devices under deep anesthesia in children found that 97% of these events were respiratory issues, with some leading to serious complications like cardiac arrest.

While serious adverse events were identified, including one fatality, the majority were deemed preventable, and no respiratory events resulted in long-term harm, highlighting the need for improved monitoring and emergency preparedness during anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications associated with removal of airway devices under deep anesthesia in children: an analysis of the Wake Up Safe database. Vitale, L., Rodriguez, B., Baetzel, A., et al.[2022]

Supraglottic airway devices are generally safe for use in elective surgeries and difficult airway management, with a very low incidence of serious complications like gastric content aspiration (estimated at 0.02%).

While serious complications are rare, mild adverse effects such as sore throat and dysphagia are more common, highlighting the importance of following manufacturer guidelines to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications Associated with the Use of Supraglottic Airway Devices in Perioperative Medicine. Michalek, P., Donaldson, W., Vobrubova, E., et al.[2022]

In a study of 171 patients undergoing prolonged ENT surgeries, the use of laryngeal mask airway (LMA) resulted in significantly lower rates of hoarseness (3.5% vs. 24.4%) and cough (1.2% vs. 7%) compared to endotracheal intubation.

Overall, LMA was associated with fewer postoperative respiratory complications, suggesting it may be a safer alternative for airway management in prolonged surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Respiratory Complications of Laryngeal Mask Airway and Tracheal Tube in Ear, Nose and Throat Operations. Safaeian, R., Hassani, V., Movasaghi, G., et al.[2022]

References

1. India pubmed.ncbi.nlm.nih.gov

Comparative Study of Two Laryngeal Mask Airways: Proseal Laryngeal Mask Airway and Supreme Laryngeal Mask Airway in Anesthetized Paralyzed Adults Undergoing Elective Surgery. [2022]

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

Supraglottic airway devices. [2022]

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

Advances in supraglottic airway devices for the management of difficult airways in children. [2016]

4. 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]

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

Postoperative management following supraglottoplasty for severe laryngomalacia. [2022]

6. Italy pubmed.ncbi.nlm.nih.gov

Supraglottic airway devices: indications, contraindications and management. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Incidence of and risk factors for difficult ventilation via a supraglottic airway device in a population of 14,480 patients from South-East Asia. [2016]

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

Predictors and clinical outcomes from failed Laryngeal Mask Airway Unique™: a study of 15,795 patients. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Complications associated with removal of airway devices under deep anesthesia in children: an analysis of the Wake Up Safe database. [2022]

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

Complications Associated with the Use of Supraglottic Airway Devices in Perioperative Medicine. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Postoperative Respiratory Complications of Laryngeal Mask Airway and Tracheal Tube in Ear, Nose and Throat Operations. [2022]