NCT06521749

Universal Stylet Bougie in Patients with Cervical Neck Immobilization.

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Theodor Bilharz Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intubating Condition

Interventions

Type	Name	Description
DEVICE	USB as a stylet	USB used as a bougie
DEVICE	USB as a bougie	USB used as a bougie

Timeline

• Start date: 2024-03-03
• Primary completion: 2024-06-30
• Completion: 2024-07-15
• First posted: 2024-07-26
• Last updated: 2024-09-19

Locations

1 site across 1 country: Egypt