None listed
Conditions
Brief 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).
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 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 an
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.,
Sponsors
General University Hospital in Prague
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. emergency procedures of maxillofacial and dental surgery requiring nasotracheal intubation 2. expected difficult airway management - limited mouth opening (less than 2.5 cm), Mallampati score 3 or 4
Exclusion criteria
1. Inability to communicate in Czech languege 2. Inability to understand and sign the informed consent 3. Expected easy tracheal intubation
Outcome results
None listed