Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521749
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
Universal Stylet Bougie in Patients with Cervical Neck Immobilization
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating the Use of the Universal Stylet Bougie USB on Successful Intubation on the First Attempt Among Patients with Cervical Spine Immobilization by Using a Rigid Collar
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In patients with cervical spine injury securing the airway while adequately immobilizing the cervical spine to avoid secondary neurological damage is very challenging Although awake fiber-optic intubation is the most reliable method in patients with cervical trauma it has some limitations such as lack of availability need for expertise in the use difficulty with non-cooperative patients or presence of blood or secretions in the airway Two devices are commonly used to facilitate tracheal intubation a stylet or a tracheal tube introducer bougie
Detailed Description:
The Universal Stylet Bougie or USB represents a significant advance in the design and development of tracheal introducers bougies and stylets Traditionally the design requirements of styles and bougies have always been considered incompatible A stylet requires sufficient rigidity to allow the tracheal tube to be manipulated to a variety of angles whereas a bougie needs to be flexible enough to allow positive tracheal ring feedback to allow correct placement
The unique design of the USB means the device can be used as a stylet or as a bougie It consists of two metals inserted on both sides and a flexible middle section The USB can easily be manipulated to a variety of angles when used as a stylet yet has the flexibility when used as a bougie In addition the hexagonal shape provides less contact with the inner surface of the tracheal tube providing particularly easy insertion and removal
In this study we are simulating a difficult intubating condition by limiting the cervical neck extension through applying a rigid neck collar Subsequently we will assess whether using the USB device could improve the successful rate of intubation in these patients
The unique design of the USB means the device can be used as a stylet or as a bougie It consists of two metals inserted on both sides and a flexible middle section The USB can easily be manipulated to a variety of angles when used as a stylet yet has the flexibility when used as a bougie In addition the hexagonal shape provides less contact with the inner surface of the tracheal tube providing particularly easy insertion and removal
In this study we are simulating a difficult intubating condition by limiting the cervical neck extension through applying a rigid neck collar Subsequently we will assess whether using the USB device could improve the successful rate of intubation in these patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None