Universal Stylet Bougie in Patients with Cervical Neck Immobilization.

NCT ID: NCT06521749

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-03
• Study Completion Date: 2024-07-15

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.

Conditions

Intubating Condition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

the Bougie group (group A)

Endotracheal intubation will be attempted using the video laryngoscope and the USB device will be used as a bougie.

Group Type: ACTIVE_COMPARATOR

USB as a bougie

Intervention Type: DEVICE

USB used as a bougie

the stylet group ( B group)

Endotracheal intubation will be attempted using the video laryngoscope and using the USB device as a stylet.

Group Type: ACTIVE_COMPARATOR

USB as a stylet

Intervention Type: DEVICE

USB used as a bougie

the control group (C group)

Intubation of the trachea with an endotracheal tube will be attempted by using only the video laryngoscopy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

USB as a stylet

USB used as a bougie

Intervention Type: DEVICE

USB as a bougie

USB used as a bougie

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theodor Bilharz Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Moshira sayed mohamed

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moshira Amer, M.D.

Role: PRINCIPAL_INVESTIGATOR

Theodor Bilharz Research Institute

Locations

Theodor Bilharz Research Institute

Giza, Giza Governorate, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 36868945 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37587618 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35260735 (View on PubMed)

Other Identifiers

PT(823)

Identifier Type: -

Identifier Source: org_study_id