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NCT Number: NCT04498598

Structural Modification In Supraglottic Airway Device

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.

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Key information

Conditions

Airway Complication of Anesthesia Hypoventilation Hypoxia Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Ventilation Therapy; Complications

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Rafi Avitsian, MD

CONTACT

[email protected]

216-444-9735

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

A/Z Supraglottic airway

Device

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

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

    Time frame: During and immediately after the intervention

    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.

Secondary outcomes

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

    Time frame: During and immediately after intervention

    Evaluate if a modification of configuration on "Laryngeal Mask Airway" improves safety during Supraglottic to Endotracheal conversion without using an exchange catheter

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

    Time frame: During and immediately after intervention

    Evaluate if this modification can enhance smooth extubation after endotracheal intubation by converting an endotracheal tube to a supraglottic airway

Study contacts

Contact information is provided by the study sponsor or research team.

Mark Mettler

CONTACT

[email protected]

216-445-8281

Rafi Avitsian, MD

CONTACT

[email protected]

216-444-9735

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 4, 2020
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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