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OpenTrials
Completed

NCT Number: NCT06521749

Universal Stylet Bougie in Patients with Cervical Neck Immobilization.

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").

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Theodor Bilharz Research Institute

Giza, Giza Governorate, 02, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

USB as a stylet

Device

USB used as a bougie

USB as a bougie

Device

USB used as a bougie

Primary outcomes

  1. Time required for intubation.

    Time frame: 30 seconds - 2 minutes

Secondary outcomes

  1. number of attempts

    Time frame: 30 seconds to 2 minutes

Sponsors and collaborators

Lead sponsor

Theodor Bilharz Research Institute

Other

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 26, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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