Modification of a supraglottic airway device for better ventilation
Structural Modification In Supraglottic Airway Device Enhances Exchange Between Supraglottic & Endotracheal Ventilation Modes
This study tests a new design of a breathing device to see if it makes it easier for doctors to switch to a breathing tube during anesthesia for adult patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04498598 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new design of a supraglottic airway device that allows for easier conversion to endotracheal ventilation without the need for an exchange catheter. The modified device features an opening that enables access to an endotracheal tube, facilitating smoother airway management during anesthesia. The feasibility of this modification has been previously tested on manikins, and this trial aims to assess its effectiveness in real clinical settings. The study will involve adult patients scheduled for general anesthesia procedures requiring endotracheal intubation.
Who should consider this trial
Good fit: Ideal candidates are adult patients scheduled for general anesthesia procedures that require endotracheal intubation.
Not a fit: Patients with a history of difficult airways or those requiring special equipment for airway management may not benefit from this study.
Why it matters
Potential benefit: If successful, this modification could enhance airway management during anesthesia, potentially reducing complications related to ventilation.
How similar studies have performed: While this approach is innovative, similar modifications in airway devices have shown promise in improving ventilation outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients 2. scheduled for a general anesthesia procedure with ETT \& muscle relaxation Exclusion Criteria: 1. Patients who are not able to consent 2. Non English Speaking 3. History of difficult airway 4. Physical exam of airway which suggests difficulty in airway management or need to use special equipment 5. BMI \>35 6. Gastroesophageal reflux disease 7. Anesthetic plan other than general anesthesia 8. Emergency procedures
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Rafi Avitsian, MD
- Email: avitsir@ccf.org
- Phone: 216-444-9735
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.