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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new version of a supraglottic airway device, which helps with breathing during surgery and simplifies switching between different types of ventilation without extra equipment. The focus is on improving airway management during surgeries using general anesthesia. It is ideal for adults scheduled for surgery who need a breathing tube and muscle relaxation. As an unphased trial, it allows patients to contribute to advancements in surgical airway management.

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 prior data suggests that this modified supraglottic airway device is safe for ventilation therapy?

Research has shown that supraglottic airway devices, like the one being studied, are generally safe. They are less invasive than traditional methods such as tracheal intubation, which involves inserting a tube into the windpipe, making them a safer choice for many patients.

However, like any medical device, some risks exist. Common issues include minor injuries or discomfort, such as coughing or soreness, while serious complications are rare. Studies have found that injuries from these devices are uncommon and usually not severe.

The A/Z supraglottic airway is a modified version of these devices. Based on well-known techniques, it is expected to be similarly safe. Patients should always discuss any concerns with their doctor, who can provide advice specific to their health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for airway management during surgery, which typically involves endotracheal intubation or traditional supraglottic airway devices, the A/Z Supraglottic Airway is designed to potentially reduce complications and improve ventilation. Researchers are excited about this device because it offers a modified design that could enhance the safety and comfort for patients under general anesthesia. By providing a more effective and less invasive option, this new device has the potential to optimize airflow and minimize the risk of airway injury compared to conventional methods.

What evidence suggests that this modified supraglottic airway device is effective for ventilation therapy complications?

Research has shown that supraglottic airway devices are generally safe and effective for assisting patients' breathing during surgeries. One study found that these devices successfully provided ventilation 94.1% of the time when traditional methods failed. Another study noted that serious issues, such as inhaling foreign objects, are rare and preventable. In this trial, the A/Z supraglottic airway, a new version under study, easily switches between two breathing methods without extra tools, potentially increasing its usefulness in emergencies. Overall, evidence suggests this new device could be effective and reliable for managing airways during surgeries. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 (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 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]

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 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]

Citations

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An Evaluation of Four Supraglottic Airway Devices by ... This study aims to evaluate the time required to insert a supraglottic airway device and achieve a successful ventilation of four different devices.

2. withpower.com withpower.com/trial/phase-hypoventilation-8-2020-88396

Modified Supraglottic Airway Device for Ventilation ... Supraglottic airway devices are generally safe, with serious complications like aspiration and airway loss being rare and preventable. Mild side effects such as ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0007091224005464

Choice of supraglottic airway devices: a network meta ... The primary outcome was the incidence of postoperative sore throat (POST). Secondary outcomes were first-attempt insertion success, bleeding complications, and ...

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Supraglottic Airway Devices | Respiratory Care An observational study of LMA in subjects in whom mask ventilation or tracheal intubation was impossible showed 94.1% success rates for rescue ventilation. The ...

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Using supraglottic airways by paramedics for ... - Nature The present study is the first to analyse the performance of airway management by paramedics in simulated microgravity and to compare the ...

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Complications Associated with the Use of Supraglottic ... Arytenoid dislocation has been reported after airway maintenance with a cLMA [81] which could be caused by direct contact with arytenoids, insertion with ...

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Complications and failure of airway management Airway management complications causing temporary patient harm are common, but serious injury is rare. Because most airways are easy, most complications ...

8. liebertpub.com liebertpub.com/doi/10.4187/respcare.02884

Complications of Airway Management | Respiratory Care Endotracheal intubation can be a safe, life-saving procedure. Although rare, acute or chronic injuries can occur during endotracheal intubation. Emergent and ...

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The efficacy and the safety of supraglottic airway in... Furthermore, repeated airway manipulation can result in complications such as airway trauma, cough, aspiration, edema, laryngospasm, and bronchospasm, thus ...

10. associationofanaesthetists-publications.onlinelibrary.wiley.com associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/j.1365-2044.2011.06934.x

Supraglottic airways in difficult airway management ... Supraglottic airway devices are intrinsically more invasive than use of a facemask for anaesthesia, but less invasive than tracheal intubation.