RecruitingACTRN12618000401257

A comparison of videolaryngoscopes GlideScope and KingVision for nasotracheal intubation in maxillofacial patients with predicted difficult airway

A randomized comparison of videolaryngoscope GlideScope Titanium with videolaryngoscope KingVision (non-channeled blade) for nasotracheal intubation in patients with predicted difficult airway scheduled for maxillofacial procedure


Sponsor

General University Hospital in Prague

Enrollment

110 participants

Start Date

Jun 8, 2018

Study Type

Interventional

Conditions

Summary

Background: Videolaryngoscopy (VL) may improve intubation conditions in majority of patients, where the classical Macintosh laryngoscopy would be difficult or even may fail. Newer videolaryngoscopes posses smaller screens, they are also more portable and could be used outside the operating room. Modern videolaryngoscopes are also designed for visualization of the vocal cords in patients with limited mouth opening because of more slim shape of the blade. VL GlideScope Titanium is non-channeled videolaryngoscope with a slim reusable titanium blade and attached monitor while the VL KingVision is a portable device that can use a special single-use slim plastic blade theoretically useful in difficult nasotracheal intubation. Design: A randomized, interventional, single-blinded trial Objective: To evaluate in emergency patients scheduled for maxillofacial or dental surgery under general anaesthesia and requiring nasotracheal intubation whether the application of different videolaryngoscopes in the operating room has a different time to the successful placement of endotracheal tube through a nasal route. Primary outcome: time to successful intubation (sec) Secondary outcomes: total number of attempts, total success rate, visualization of the larynx. Methodology and sample size calculation: The average time intubation using GlideScope VL was reported as 49 (SD +/- 9) sec. Statistically significant difference was set as 5 sec (10%) - sample size was calculated using freeware: http://powerandsamplesize.com, with a power of 80% and type I error of 5%, Minimum number of patients in one group was calculated as 51. Including patients who do not complete the study for various reasons we decided to enrol total number of 110 patients (55 per group).


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 90 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of video camera laryngoscopes — specialised devices used to guide a breathing tube into a patient's airway through the nose during surgery. Patients needing jaw or dental surgery sometimes have limited mouth opening, making standard airway management very challenging. Video laryngoscopes allow the surgical team to see inside the airway on a screen, improving safety. The two devices being compared are the GlideScope Titanium and the KingVision. Patients scheduled for this type of surgery will be randomly assigned to have their airway managed with one of the two devices, and the time taken to successfully place the breathing tube will be recorded along with the number of attempts required. To be eligible, you need to be an adult patient scheduled for emergency jaw or dental surgery requiring a breathing tube placed through the nose, with limited mouth opening or a high Mallampati score (an indicator of potentially difficult airway management). This trial is being conducted at a hospital in Prague, Czech Republic.

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Interventions

ARM 1: Nasotracheal intubation with videolaryngoscope GlideScope Titanium 1. Participants receive Study Information Pack in advance at least 1 hour prior to enrolment (the patients are acute due to

ARM 1: Nasotracheal intubation with videolaryngoscope GlideScope Titanium 1. Participants receive Study Information Pack in advance at least 1 hour prior to enrolment (the patients are acute due to maxillofacial trauma/abscess). This pack contains description of interventions, summary of risks associated with videolaryngoscopy and detailed information about the study process, 2. Nasotracheal intubation using the GlideScope Titanium videolaryngoscope a) after standardized induction to general anaesthesia - preoxygenation, 100% oxygen for 5 min, propofol 2mg/kg, sufentanil 0,15 mcg/kg, suxamethonium 1.5 mg/kg - the GlideScope Titanium videolaryngoscope is inserted to the patient mouth in order to visualize the vocal cords. A soft tracheal tube is subsequently introduced into trachea and cuff of the tube is inflated with small amount of air to form a seal. Pressure inside the cuff is measured in order to achieve pressures 20-22 cmH20. Tracheal tube is kept in place for the duration of surgery. b) time of device (Glidescope Titanium videolaryngoscope) - the device is inserted after induction to general anaesthesia and removed after successful insertion of tracheal tube. c) the device is inserted by a doctor with Board Certification in Anaesthesia - anaesthetist d) approximate duration of the videolaryngoscope in place is one minute e) features differing from the control/comparator videolaryngoscope - different shape of the blade, different monitor for visualization of the vocal cords.,


Locations(1)

Czech Republic

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ACTRN12618000401257