Structural Modification In Supraglottic Airway Device

Structural Modification In Supraglottic Airway Device Enhances Exchange Between Supraglottic & Endotracheal Ventilation Modes

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.

Study Overview

• Status: Recruiting
• Conditions: Hypoxia; Airway Complication of Anesthesia; Hypoventilation; Ventilation Therapy; Complications
• Intervention / Treatment: Device: A/Z Supraglottic airway

Detailed Description

The special design allows conversion of a telescopic coaxial portion (R piece), replacing with an ETT which can act coaxially to provide both supraglottic (up position) and endotracheal (down position) of ETT. See this modification in https://www.youtube.com/watch?v=iy84lALU1aI

Currently the proposed change to the conventional SGA has been made and feasibility tested on Manikins. The A/Z airway modification is also demonstrated in the attached link video https://www.youtube.com/watch?v=ukLOAC55iG8

In this study, we are trialing the A/Z concept on an original A/Z modification by a manufacturer on their currently used SGA. Thus instead of investigators making the changes by cutting a channel in a conventional SGA immediately before use in the Operating Room, they have asked a manufacturer to do so professionally.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rafi Avitsian, MD; Phone Number: 216-444-9735; Email: AVITSIR@ccf.org
• Study Contact Backup: Name: Mark Mettler; Phone Number: 216-445-8281; Email: mettlem@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Foundation
      • Contact: Rafi Avitsian, MD; Phone Number: 216-444-9735; Email: AVITSIR@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A/Z Airway; Patients under general anesthesia for surgical procedures who need airway management for ventilation.	Device: A/Z Supraglottic airway; Patient receive supraglottic airway for general anesthesia which can be converted to endotracheal ventilation reversibly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful exchange from supraglottic to endotracheal ventilation using A/Z modified SGA	Evaluate if a modification of configuration on "Laryngeal Mask Airway" improves safety during Supraglottic to Endotracheal conversion without using an exchange catheter	During and immediately after intervention
Rate of successful exchange from endotracheal to supraglottic ventilation using A/Z modified SGA	Evaluate if this modification can enhance smooth extubation after endotracheal intubation by converting an endotracheal tube to a supraglottic airway	During and immediately after intervention

Collaborators and Investigators

• Sponsor: The Cleveland Clinic

Publications and helpful links

Helpful Links

• Conference Abstracts

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Estimated): August 24, 2026
• Study Completion (Estimated): August 24, 2026

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Airway Management; Supraglottic Airway; Oxygenation and Ventilation; Airway Devices
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Respiratory Aspiration; Hypoxia; Hypoventilation
• Other Study ID Numbers: 20-163

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Journal Abstracts
   Information comments: A. Varvinskiy, T. Hinde, 21st Annual Scientific Meeting of the Difficult Airway Society: lessons learned and glimpses of the future , BJA: British Journal of Anaesthesia, Volume 119, Issue 3, September 2017, Pages e31-e47,
2. Journal Abstacts
   Information comments: J. Law, I. Morris, Historical cohort study of 10 288 tracheal intubations facilitated by video laryngoscopy, British Journal of Anaesthesia, Volume 121, Issue 1, 2018, Pages e1-e2, ISSN 0007-0912, https://doi.org/10.1016/j.bja.2018.02.037. (https://www.sciencedirect.com/science/article/pii/S0007091218301831)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No