Clinical trial NCT06521749: Universal Stylet Bougie in Patients with Cervical Neck Immobilization.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubating Condition
Keywords: USB, cervical immobilization, rigid collar
Lead sponsor: Theodor Bilharz Research Institute
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be allocated, according to the study group into:

1. Bougie Group: (Group A) Endotracheal intubation will be attempted using the video laryngoscope and the USB device will be used as a bougie.
2. Stylet Group: ( Group B) Endotracheal intubation will be attempted using the video laryngoscope and using the USB device as a stylet.
3. Control Group: (Group C) Intubation of the trachea with an endotracheal tube will be attempted by using only the video laryngoscopy.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time required for intubation.
timeFrame: 30 seconds - 2 minutes
Secondary outcomes:
measure: number of attempts
timeFrame: 30 seconds to 2 minutes
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Theodor Bilharz Research Institute
Study officials:
affiliation: Theodor Bilharz Research Institute
name: Moshira Amer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maremanda KR, Jayaram K, Durga P. Comparison of Intubation Conditions Between Airtraq, McGrath Video Laryngoscopes, and Macintosh Under Conditions of Simulated Trauma Airway and Rapid Sequence Induction Intubation. J Emerg Med. 2023 Mar;64(3):271-281. doi: 10.1016/j.jemermed.2022.12.014. Epub 2023 Mar 2.
citation: Karlsen KAH, Gisvold SE, Nordseth T, Fasting S. Incidence, causes, and management of failed awake fibreoptic intubation-A retrospective study of 833 procedures. Acta Anaesthesiol Scand. 2023 Nov;67(10):1341-1347. doi: 10.1111/aas.14313. Epub 2023 Aug 16.
citation: Kuo YM, Lai HY, Tan EC, Li YS, Chiang TY, Huang SS, Huang WC, Chu YC. Cervical spine immobilization does not interfere with nasotracheal intubation performed using GlideScope videolaryngoscopy: a randomized equivalence trial. Sci Rep. 2022 Mar 8;12(1):4041. doi: 10.1038/s41598-022-08035-0.