Structural Modification In Supraglottic Airway Device

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: A/Z Supraglottic airway


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airway Management, Oxygenation and Ventilation, Airway Devices, Supraglottic Airway