Structural Modification In Supraglottic Airway Device

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Airway Complication of Anesthesia
Hypoventilation
Hypoxia
Ventilation Therapy; Complications

Clinical Trial Details

NCT number	NCT04498598
Study type	Interventional
Source	The Cleveland Clinic
Contact	Rafi Avitsian, MD
Phone	216-444-9735
Email	avitsir@ccf.org
Status	Recruiting
Phase	N/A
Start date	September 30, 2020
Completion date	December 31, 2024

View Details

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