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Structural Modification In Supraglottic Airway Device

Primary Purpose

Airway Complication of Anesthesia, Ventilation Therapy; Complications, Hypoxia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A/Z Supraglottic airway
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Airway Complication of Anesthesia focused on measuring Airway Management, Oxygenation and Ventilation, Airway Devices, Supraglottic Airway

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic FoundationRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A/Z Airway

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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

Full Information

First Posted
July 13, 2020
Last Updated
August 14, 2023
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04498598
Brief Title
Structural Modification In Supraglottic Airway Device
Official Title
Structural Modification In Supraglottic Airway Device Enhances Exchange Between Supraglottic & Endotracheal Ventilation Modes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Complication of Anesthesia, Ventilation Therapy; Complications, Hypoxia, Hypoventilation
Keywords
Airway Management, Oxygenation and Ventilation, Airway Devices, Supraglottic Airway

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A/Z Airway
Arm Type
Experimental
Arm Description
Patients under general anesthesia for surgical procedures who need airway management for ventilation.
Intervention Type
Device
Intervention Name(s)
A/Z Supraglottic airway
Intervention Description
Patient receive supraglottic airway for general anesthesia which can be converted to endotracheal ventilation reversibly
Primary Outcome Measure Information:
Title
Test effect of A/Z modification of supraglottic airway device on rate of successful oxygenation and ventilation before beginning a full clinical trial
Description
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.
Time Frame
During and immediately after the intervention
Secondary Outcome Measure Information:
Title
Rate of successful exchange from supraglottic to endotracheal ventilation using A/Z modified SGA
Description
Evaluate if a modification of configuration on "Laryngeal Mask Airway" improves safety during Supraglottic to Endotracheal conversion without using an exchange catheter
Time Frame
During and immediately after intervention
Title
Rate of successful exchange from endotracheal to supraglottic ventilation using A/Z modified SGA
Description
Evaluate if this modification can enhance smooth extubation after endotracheal intubation by converting an endotracheal tube to a supraglottic airway
Time Frame
During and immediately after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafi Avitsian, MD
Phone
216-444-9735
Email
avitsir@ccf.org
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Mettler
Phone
216-445-8281
Email
mettlem@ccf.org
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafi Avitsian, MD
Phone
216-444-9735
Email
AVITSIR@ccf.org

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://doi.org/10.1093/bja/aex213
Description
Conference Abstracts

Learn more about this trial

Structural Modification In Supraglottic Airway Device

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