Actively Recruiting
Structural Modification In Supraglottic Airway Device Enhances Exchange Between Supraglottic & Endotracheal Ventilation Modes
Led by The Cleveland Clinic · Updated on 2026-05-07
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new modification to the supraglottic airway (SGA) device designed to improve airway management during general anesthesia. This modified device, called the A/Z modification, features an opening that allows an endotracheal tube (ETT) to be inserted through the SGA body without needing an exchange catheter. This innovation aims to enable easy conversion between supraglottic and endotracheal ventilation modes during surgery, addressing complications related to airway management, ventilation therapy, hypoxia, and hypoventilation. The study involves patients undergoing general anesthesia who require airway management for ventilation. Participants will receive the A/Z modified supraglottic airway device, which can be converted reversibly to endotracheal ventilation by replacing a special adapter piece with an ETT. This device modification has been professionally manufactured and tested for feasibility on manikins before clinical trial use. The intervention focuses on how well the device supports oxygenation and ventilation and how successfully it allows switching between ventilation modes during and immediately after use. During the study, participants will receive airway management with the A/Z modified device while under general anesthesia for surgical procedures. Researchers will measure the rate of successful oxygenation and ventilation, as well as the ease of converting between supraglottic and endotracheal ventilation. These outcomes will be assessed during and immediately after the intervention. The trial excludes patients with anticipated airway difficulties or other factors that could affect airway management. Participation lasts through the anesthesia procedure and immediate recovery period to evaluate device performance and safety.
CONDITIONS
Brief Title
Structural Modification In Supraglottic Airway Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients
- Scheduled for a general anesthesia procedure with endotracheal tube and muscle relaxation
You will not qualify if you...
- Patients unable to consent
- Non English speaking
- History of difficult airway
- Physical exam suggesting difficult airway or need for special equipment
- Body mass index greater than 35
- Gastroesophageal reflux disease
- Anesthetic plan other than general anesthesia
- Emergency procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During the surgical procedure
Participants undergo airway management using the A/Z modified supraglottic airway device during general anesthesia for their surgical procedure.
1 surgical procedure visit (in-person)
Trial Site Locations
Total: 1 location
1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
R
Rafi Avitsian, MD
M
Mark Mettler
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here