Universal Stylet Bougie in Patients with Cervical Neck Immobilization.

NCT06521749 | Completed DMC

• 1 other identifier: PT(823)
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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").

Conditions

Intubating Condition

Keywords

USB, cervical immobilization, rigid collar

Outcome Measures

Primary Outcomes (1)

• Time required for intubation.

  30 seconds - 2 minutes

Secondary Outcomes (1)

• number of attempts

  30 seconds to 2 minutes

Study Arms (3)

the Bougie group (group A)

ACTIVE COMPARATOR

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

Device: USB as a bougie

the stylet group ( B group)

ACTIVE COMPARATOR

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

Device: USB as a stylet

the control group (C group)

NO INTERVENTION

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

Interventions

USB as a stylet DEVICE

USB used as a bougie

the stylet group ( B group)

USB as a bougie DEVICE

USB used as a bougie

the Bougie group (group A)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (1)

Theodor Bilharz Research Institute

Giza, Giza Governorate, 02, Egypt

Location

Related Publications (3)

• 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.

  PMID: 36868945 BACKGROUND

• 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.

  PMID: 37587618 BACKGROUND

• 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.

  PMID: 35260735 BACKGROUND

Study Officials

• Moshira Amer, M.D.

  Theodor Bilharz Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: the investigator responsible for data collection and the patients participating in the study will not be aware of the group assignment.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: July 26, 2024
• Study Start: March 3, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 15, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)