Modified Supraglottic Airway Device for Ventilation Therapy Complications
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?
Is the modified supraglottic airway device generally safe for humans?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Trialing the A/Z concept on an original A/Z modification by a manufacturer on their currently used SGA
Follow-up
Participants are monitored for safety and effectiveness after the intervention
Treatment Details
Interventions
- A/Z Supraglottic airway
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor