Structural Modification In Supraglottic Airway Device

NCT04498598 | Recruiting FDA Device

• 1 other identifier: 20-163
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Airway Management; Oxygenation and Ventilation; Airway Devices; Supraglottic Airway

Outcome Measures

Primary Outcomes (1)

• Test effect of A/Z modification of supraglottic airway device on rate of successful oxygenation and ventilation before beginning a full clinical trial

  An alteration and structural modification in the supraglottic airway device can improve safety of airway exchange in patient needing general anesthesia, this proof of concept should show if the modification has any affect on oxygenation and ventilation.

  During and immediately after the intervention

Secondary Outcomes (2)

• Rate of successful exchange from supraglottic to endotracheal ventilation using A/Z modified SGA

  During and immediately after intervention

• Rate of successful exchange from endotracheal to supraglottic ventilation using A/Z modified SGA

  During and immediately after intervention

Study Arms (1)

A/Z Airway

EXPERIMENTAL

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

Device: A/Z Supraglottic airway

Interventions

A/Z Supraglottic airway DEVICE

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

A/Z Airway

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients
• scheduled for a general anesthesia procedure with ETT \& muscle relaxation

You may not qualify if:

• Patients who are not able to consent
• Non English Speaking
• History of difficult airway
• Physical exam of airway which suggests difficulty in airway management or need to use special equipment
• BMI \>35
• Gastroesophageal reflux disease
• Anesthetic plan other than general anesthesia
• Emergency procedures

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Hypoxia; Hypoventilation; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Central Study Contacts

Rafi Avitsian, MD

CONTACT

216-444-9735; avitsir@ccf.org

Mark Mettler

CONTACT

216-445-8281; mettlem@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: August 4, 2020
• Study Start: September 30, 2020
• Primary Completion: February 24, 2026
• Study Completion: February 24, 2026
• Last Updated: March 4, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)