A Comparison Between Using Video Stylet and Video Laryngoscope in Difficult Intubation of Traumatic Patients .

NCT05143346 | Completed DMC

• 1 other identifier: Difficult intubation
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the visualization of the glottis, the time for tracheal intubation, the success rate of intubation, and the need for manoeuvres to optimize the view using video stylet or video laryngoscope in patients with expected difficult intubations.

Conditions

Difficult or Failed Intubation

Outcome Measures

Primary Outcomes (1)

• Comparison of success rate for the tracheal intubation in patients with anticipated difficult airways, demonstrating the non inferiority of video stylet efficacy compare to the most consolidated technique based on videolaryngoscope

  The success rate of the rigid fiberoptic stylet to perform tracheal intubation in patients with anticipated difficult airways \[ Time Frame: up to a maximum of 3 attempts and up to 3 minutes from device insertion for each attempt (max 3 minutes) \] . success rate of the procedure defined as correct positioning of the tracheal tube in the trachea confirmed both endoscopically and through the capnographic curve end tidal carbon dioxide (Et CO2) time consumed to achieve a successful intubation by each device.

  5 minutes

Secondary Outcomes (2)

• Average time of intubation procedure expressed in seconds [ Time Frame: up to 3 minutes ]

  3 minutes

• Development of any complications [ Time Frame: up to 6 hours measured from the insertion of the device ]

  6 hours

Study Arms (2)

Group A

OTHER

Group A will include 33 patients and will be intubated by the use of video stylet.

Device: Intubation

Group B

OTHER

Group B will include 33 patients and will intubated by the use of video laryngoscope

Device: Intubation

Interventions

Intubation DEVICE

Using video stylet and video laryngoscope in difficult intubation in patients with trauma or suspected to be have difficult intubation.

Group A; Group B

Eligibility Criteria

• Age: 5 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient in the age group of (5 - 80) and has
• Suspected difficult intubation.
• High mallampati score (class 111, 1V).
• Suspected cervical fracture.
• Maxillofacial trauma.
• Fracture base of the skull.
• Polytrauma.

You may not qualify if:

• Patients with low mallampati score (class 1, 11).
• Patients undergoing elective surgeries and not suspected to have difficult intubations.
• Patients aged below 5 years and above 80 years.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Wesam Mahran

Asyut, 71511, Egypt

Location

Related Publications (2)

• Tosone SR, Reves JG, Kissin I, Smith LR, Fournier SE. Hemodynamic responses to nifedipine in dogs anesthetized with halothane. Anesth Analg. 1983 Oct;62(10):903-8.

  PMID: 6614523 BACKGROUND

• Hayat K, Finnegan M, Lee KA, Rees RC, Hancock BW, Goyns MH. Variable expression of the interleukin-2 receptor alpha chain and MYC genes in lymphocytes from renal cell carcinoma patients treated with interleukin-2. Cancer Lett. 1992 Aug 14;65(2):173-8. doi: 10.1016/0304-3835(92)90163-p.

  PMID: 1511423 BACKGROUND

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 23, 2021
• First Posted: December 3, 2021
• Study Start: October 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: May 1, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

EG (1)