Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04498598
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2020-07-13
Brief Title:
Structural Modification In Supraglottic Airway Device
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Structural Modification In Supraglottic Airway Device Enhances Exchange Between Supraglottic Endotracheal Ventilation Modes
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed AZ 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 httpswwwyoutubecomwatchviy84lALU1aI
Currently the proposed change to the conventional SGA has been made and feasibility tested on Manikins The AZ airway modification is also demonstrated in the attached link video httpswwwyoutubecomwatchvukLOAC55iG8
In this study we are trialing the AZ concept on an original AZ 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
Currently the proposed change to the conventional SGA has been made and feasibility tested on Manikins The AZ airway modification is also demonstrated in the attached link video httpswwwyoutubecomwatchvukLOAC55iG8
In this study we are trialing the AZ concept on an original AZ 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None