100 Participants Needed

Modified Supraglottic Airway Device for Ventilation Therapy Complications

RA
MM
Overseen ByMark Mettler
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Cleveland Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.1261011

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.
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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 OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: A/Z AirwayExperimental Treatment1 Intervention
Patients under general anesthesia for surgical procedures who need airway management for ventilation.

Find a Clinic Near You

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

References

Comparative Study of Two Laryngeal Mask Airways: Proseal Laryngeal Mask Airway and Supreme Laryngeal Mask Airway in Anesthetized Paralyzed Adults Undergoing Elective Surgery. [2022]
Supraglottic airway devices. [2022]
Advances in supraglottic airway devices for the management of difficult airways in children. [2016]
The supraglottic airway device as first line of management in anticipated difficult mask ventilation in the morbidly obese. [2022]
Postoperative management following supraglottoplasty for severe laryngomalacia. [2022]
Supraglottic airway devices: indications, contraindications and management. [2019]
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]
Predictors and clinical outcomes from failed Laryngeal Mask Airway Unique™: a study of 15,795 patients. [2022]
Complications associated with removal of airway devices under deep anesthesia in children: an analysis of the Wake Up Safe database. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Complications Associated with the Use of Supraglottic Airway Devices in Perioperative Medicine. [2022]
Postoperative Respiratory Complications of Laryngeal Mask Airway and Tracheal Tube in Ear, Nose and Throat Operations. [2022]