The aim of this open-label, randomized, 3-parallel arm trial is to compare success of intubation rate at first try between three groups that will be intubated: 1. Conventional intubation with hyperangulated videolaryngoscope (control group), 2. Intubation ProVu TM video stylet combined with hyperangulated videolaryngoscope, 3. Intubation ProVu TM video stylet combined with standard Macintosh laryngoscope.
Critical anesthetic incidents in the operating room are often related to airway management. Difficult airway management is defined as the clinical situation in which an anesthesiologist with conventional training has difficulty with upper airway face mask ventilation, difficulty with tracheal intubation, or both. Airway management has undergone a major transformation since the development of hyper-angle videolaryngoscopy (VL). Recently, the ProVuTM video stylet (Flexicare Medical Ltd, Mountain Ash, UK), which combines visualization technology with a tube guidance system, has been proposed as a new device for endotracheal intubation in participants with difficult airway management. The investigators hypothesized that the ProVuTM video stylet combined with videolaryngoscopy or standard laryngoscopy may improve the success rate of intubation on the first attempt compared with using a videolaryngoscope alone in patientes with predicted difficult intubation. In fact, using ProVuTM the position of the video stylet tip can be adjusted continuously during the tracheal intubation maneuver.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
114
After the induction of general anesthesia, the patient will undergo conventional intubation with hyperangulated videolaryngoscope
After the induction of general anesthesia, the patient will undergo intubation with ProVu TM video stylet combined with hyperangulated videolaryngoscope
Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
Alessandria, Piedmont, Italy
Success rate on first intubation attemps
The first-attempt intubation success is defined as tracheal tube placement with a single maneuver after insertion of the tube in the mouth. Reinsertion of the tube in the mouth counts as an additional attempt.
Time frame: During the procedure
Time of intubation
Time from insertion of the laryngoscope beyond the dental rhyme to cuffed tube
Time frame: During the procedure
Time of laryngoscopy
Time from insertion of the laryngoscope beyond the dental rhyme to the insertion of the tube beyond the dental rhyme
Time frame: During the procedure
Number of intubation attempts
Times of reinsertion of the tube beyond the dental rhyme
Time frame: During the procedure
Complications
Evaluation of the type and rate of complications, including desaturation \< 90%, esophageal intubation, tooth breakage and bleeding from the oropharyngeal mucosa
Time frame: During the procedure
Use of "jaw trust" or "BURP"
Need to perform adjuvant maneuvers (jaw trust or BURP), measured with yes/no
Time frame: During the procedure
Need of another anesthesiologist intervention
Required intervention of another anesthesiologist, measured with yes/no, after 3 failed intubation attempt or after request of the first anesthesiologist
Time frame: During the procedure
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After the induction of general anesthesia, the patient will undergo intubation with ProVu TM video stylet combined with standard Macintosh laryngoscope
Needs to change the path of the intubation strategy
Needs to change intubation strategy, measured with yes/no, includes use of fiberoptic intubation, change of videolaryngoscope or postpone intervention
Time frame: During the procedure
Learning curve analysis of intubation rate success
Improvement of intubation rate success
Time frame: Through study completion, an average of 1 year
Learning curve analysis of time of procedure
Improvement of time of procedure
Time frame: Through study completion, an average of 1 year