NCT04498598 Structural Modification In Supraglottic Airway Device
| NCT ID | NCT04498598 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Airway Complication of Anesthesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2020-09-30 |
| Primary Completion | 2026-08-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2020-09-30 with a primary completion date of 2026-08-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04498598 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Airway Complication of Anesthesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04498598 currently recruiting?
Yes, NCT04498598 is actively recruiting participants. Contact the research team at avitsir@ccf.org for enrollment information.
Where is the NCT04498598 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT04498598 clinical trial?
NCT04498598 is sponsored by The Cleveland Clinic. The trial plans to enroll 100 participants.