Recruiting

Supraglottic Airway

Sponsor:

The Cleveland Clinic

Code:

NCT04498598

Conditions

Airway Complication of Anesthesia

Ventilation Therapy; Complications

Hypoxia

Hypoventilation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

A/Z Supraglottic airway

Study Details

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.

Conditions

Airway Complication of Anesthesia

Ventilation Therapy; Complications

Hypoxia

Hypoventilation

Study ID

NCT04498598

Start date

Sep 30, 2020

Status verified date

May, 2026

Completion date

Aug 24, 2026

Anticipated

Primary completion date

Aug 24, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: A/Z Airway

Patients under general anesthesia for surgical procedures who need airway management for ventilation.

Interventions

A/Z Supraglottic airway

Patient receive supraglottic airway for general anesthesia which can be converted to endotracheal ventilation reversibly

Primary outcome measure

  • Test effect of A/Z modification of supraglottic airway device on rate of successful oxygenation and ventilation before beginning a full clinical trial [ Time Frame: During and immediately after the intervention ]

Central Contacts and Locations

Central contacts

Rafi Avitsian, MD

216-444-9735avitsir@ccf.org

Mark Mettler

216-445-8281mettlem@ccf.org

Locations

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Rafi Avitsian, MD

216-444-9735AVITSIR@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • Airway Management
  • Oxygenation and Ventilation
  • Airway Devices
  • Supraglottic Airway

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-05-07.