Clinical trial NCT05143346: A Comparison Between Using Video Stylet and Video Laryngoscope in Difficult Intubation of Traumatic Patients .
Official title: A Comparison Between Using Video Stylet and Video Laryngoscope in Difficult Intubation of Traumatic Patients .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult or Failed Intubation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 66
Sex: ALL
Minimum age (years): 5
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: The airway, breathing and circulation support '' ABCs" of trauma resuscitation were born from the assumption that correcting hypoxemia and hypotension reduces morbidity and mortality. Definitive care for severely injured or polytrauma patients includes the ability to provide advanced airway management in a variety of settings: in the emergency department, 20% to 30% intubations are for trauma. Airway management in traumatic patient presents numerous unique challenges beyond placement of an endotracheal tube, without comes dependent on the provider's ability to predict and anticipate difficulty and have a safe and executable plan. In severely injured patients, the cervical spine must be protected by in-line immobilisation during airway management. If orotracheal intubation is required, then manual in-line stabilisation is recommended to facilitate tracheal intubation to secure a space for tongue displacement into the submandibular space. However, manual in-line stabilisation can make alignment of the oral, pharyngeal and laryngeal axes difficult, resulting in a poor direct laryngoscopic view and prolonging the intubation time. Video stylets, which are portable and easier to prepare than flexible fiberoptic bronchoscopes, could be better option for tracheal intubation in patient with cervical immobilization. Previous studies have shown the usefulness of video stylets for tracheal intubation in cervical immobilized patients.

Video laryngoscopes provide a better laryngeal view. They are easy to use and have a high success rate and short intubation time in patients with predicted difficult airways. Successful use of video laryngoscopy is increasing for airway management of patients with trauma in the emergency department.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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
timeFrame: 5 minutes
Secondary outcomes:
measure: Average time of intubation procedure expressed in seconds [ Time Frame: up to 3 minutes ]
timeFrame: 3 minutes
measure: Development of any complications [ Time Frame: up to 6 hours measured from the insertion of the device ]
timeFrame: 6 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Wesam Mahran
Study officials:
References:
citation: 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.
citation: 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.