Structural Modification In Supraglottic Airway Device

NCT ID: NCT04498598

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Airway Complication of Anesthesia; Ventilation Therapy; Complications; Hypoxia; Hypoventilation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

A/Z Airway

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

Group Type: EXPERIMENTAL

A/Z Supraglottic airway

Intervention Type: DEVICE

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

Interventions

A/Z Supraglottic airway

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rafi Avitsian, MD

Role: CONTACT

avitsir@ccf.org

216-444-9735

Mark Mettler

Role: CONTACT

mettlem@ccf.org

216-445-8281

Facility Contacts

Rafi Avitsian, MD

Role: primary

AVITSIR@ccf.org

216-444-9735

Study Documents

Document Type: Journal Abstracts

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,

View Document

Document Type: Journal Abstacts

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)

View Document

Other Identifiers

20-163

Identifier Type: -

Identifier Source: org_study_id