Difficult or Failed Intubation Clinical Trial
Official title:
A Comparison Between Using Video Stylet and Video Laryngoscope in Difficult Intubation of Traumatic Patients .
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.
Status | Not yet recruiting |
Enrollment | 336 |
Est. completion date | December 1, 2024 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assiut University |
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 9 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. |
9 minutes | |
Secondary | Average time of intubation procedure expressed in seconds [ Time Frame: up to 9 minutes ] | Time in minutes measured from device insertion into the patient's mouth until the endotracheal tube will be positioned into the trachea
. |
9 minutes | |
Secondary | Development of any complications [ Time Frame: up to 12 hours measured from the insertion of the device ] | Occurrence of any complications or adverse event during the procedure (desaturation episodes, hemodynamic changes, oral-pharynx and larynx traumatism) | 12 hours |
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