None listed
Conditions
Brief summary
Background: Videolaryngoscopy (VL) may improve intubation conditions in patients, where the classical laryngoscopy is difficult or even fails. Current videolaryngoscopes have smaller screens, they are more portable and could be used outside the operating room. Current videolaryngoscopes follow two concepts - a specially curved blade with optics allowing visualization of the anatomically shifted larynx (tracheal tube is usually introduced with a stylet). The second type uses an insertion channel, which allows direct placement of endotracheal tube into the trachea. VL GlideScope Titan uses the first concept while VL KingVision is a portable tool that uses both types of blades (both concepts described above). A blade with integrated intubating channel will be used in this study. Design: A randomized, interventional, single-blinded trial Objective: To evaluate in obese patients (BMI more than 35 kg / m2) whether the application of different videolaryngoscopes in the operating room has a different time to the successful placement of endotracheal tube. 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 enroll total number of 110 patients (55 per group).
Interventions
ARM 1 - Tracheal intubation with the videolaryngoscope KingVision (channeled blade)
1. Participants receive Study Information Pack in advance at least 1 day prior to enrollment. This pack contains description of interventions, summary of risks associated with videolaryngoscopy,
1. Tracheal intubation using the KingVision videolaryngoscope with a channeled blade
a) after standardized induction to general anaesthesia - preoxygenation, 100% oxygen, CPAP 5 cmH20 for 5 min, propofol 2mg/kg, sufent
ARM 1 - Tracheal intubation with the videolaryngoscope KingVision (channeled blade) 1. Participants receive Study Information Pack in advance at least 1 day prior to enrollment. This pack contains description of interventions, summary of risks associated with videolaryngoscopy, 1. Tracheal intubation using the KingVision videolaryngoscope with a channeled blade a) after standardized induction to general anaesthesia - preoxygenation, 100% oxygen, CPAP 5 cmH20 for 5 min, propofol 2mg/kg, sufentanil 0,15 mcg/kg, rocuronium 0,6 mg/kg - the KingVision videolaryngoscope with a channeled blade is inserted to the patient mouth in order to visualize the vocal cords. 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 meaured in order to achieve pressures 20-22 cmH20. Tracheal tube is kept in place for the duration of surgery. b) time of device (KingVision 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, special channel incorporated within the blade for guiding the tracheal tube.
Sponsors
General University Hospital (Vseobecna fakultni nemocnice)
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. elective procedure requiring airway management with tracheal intubation 2. elective surgery - gynaecology, general surgery, urology, maxillofacial surgery, ENT, orthopaedics 2. obesity with Body Mass Index (BMI) more than 35 kg/m2
Exclusion criteria
Mouth opening less than 2 cm History of difficult intubation Emergency surgery Increased risk for gastric content regurgitation and/or aspiration Body Mass Index (BMI) less than 35 kg/m2 Inability to communicate in Czech language
Outcome results
None listed