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

Inclusion Criteria2

  • emergency procedures of maxillofacial and dental surgery requiring nasotracheal intubation
  • expected difficult airway management - limited mouth opening (less than 2.5 cm), Mallampati score 3 or 4

Exclusion Criteria3

  • Inability to communicate in Czech languege
  • Inability to understand and sign the informed consent
  • Expected easy tracheal intubation

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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