Universal Stylet Bougie in Patients With Cervical Neck Immobilization.

Not Applicable

Completed

• Conditions: Intubating Condition
• Interventions: Device: USB as a bougie; Device: USB as a stylet

• Registration Number: NCT06521749
• Lead Sponsor: Theodor Bilharz Research Institute

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.

Study Timeline

• Study Start: 2024-03-01
• Primary Completion: 2024-06-30
• Status Verified: 2024-07
• Study Completion: 2024-07-15
• Study First Submitted: 2024-07-21
• Study First Submitted QC: 2024-07-21
• Last Update Submitted: 2024-07-21
• Study First Posted: 2024-07-26
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. ASA (American society of Anesthesiologists) physical status 1-2.
2. Age 18- 60 years old of both sexes.
3. Patients undergoing elective surgery under general anesthesia and tracheal intubation.

Exclusion Criteria

1. Age < 18 years and ≥ 60 years
2. Pregnancy
3. Patients with BMI >35 kg m-2
4. Emergency surgery or full stomach
5. Patients with suspected difficult airway {e.g., high neck circumference, airway masses, mouth scars, neck scars, or history of snoring).
6. Patients with cervical spine pathology
7. Patients with any cardiac disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the Bougie group (group A)	USB as a bougie	Endotracheal intubation will be attempted using the video laryngoscope and the USB device will be used as a bougie.
the stylet group ( B group)	USB as a stylet	Endotracheal intubation will be attempted using the video laryngoscope and using the USB device as a stylet.

Primary Outcome Measures

Name	Time	Method
Time required for intubation.	30 seconds - 2 minutes

Secondary Outcome Measures

Name	Time	Method
number of attempts	30 seconds to 2 minutes

Trial Locations

Locations (1)

Theodor Bilharz Research Institute; 🇪🇬 Giza, Egypt