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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A/Z Airway | Experimental | Patients under general anesthesia for surgical procedures who need airway management for ventilation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A/Z Supraglottic airway | Device | Patient receive supraglottic airway for general anesthesia which can be converted to endotracheal ventilation reversibly |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rafi Avitsian, MD | Contact | 216-444-9735 | avitsir@ccf.org | |
| Mark Mettler | Contact | 216-445-8281 | mettlem@ccf.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Journal Abstracts | View IPD |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D007040 | Hypoventilation |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012131 | Respiratory Insufficiency |
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| 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 |
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, |
| Journal Abstacts | View IPD | 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) |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |