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Structural Modification In Supraglottic Airway Device

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ClinicalTrials.gov Identifier: NCT04498598
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Airway Complication of Anesthesia Ventilation Therapy; Complications Hypoxia Hypoventilation Device: A/Z Supraglottic airway Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Structural Modification In Supraglottic Airway Device Enhances Exchange Between Supraglottic & Endotracheal Ventilation Modes
Actual Study Start Date : September 30, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04498598


Contacts
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Contact: Rafi Avitsian, MD 216-444-9735 avitsir@ccf.org
Contact: Mark Mettler 216-445-8281 mettlem@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Rafi Avitsian, MD    216-444-9735    AVITSIR@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Additional Information:
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04498598    
Other Study ID Numbers: 20-163
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by The Cleveland Clinic:
Airway Management
Oxygenation and Ventilation
Airway Devices
Supraglottic Airway
Additional relevant MeSH terms:
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Hypoventilation
Hypoxia
Signs and Symptoms, Respiratory
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases