An interventional study of Tritube and Standard enditracheal tube in Oral Neoplasm, Pharynx Cancer and Larynx Cancer, sponsored by Michael Seltz Kristensen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-29.
Sponsored by Michael Seltz Kristensen · Not applicable, Interventional, and Supportive care
The investigators compare the ease of intubation between a new ultra-thin endotracheal tube, "Tritube", and a standard endotracheal tube in patients with predictors of difficult laryngoscopy. Furthermore the investigators compare the acceptance of leaving the Tritube in trachea after end of anaesthesia, with the use of a tube exchange catheter.
In patients scheduled for surgery and anaesthesia in the Head-/neck/ear/nose/throat -region the investigators compare the ease of tracheal intubation between a new ultra-thin endotracheal tube, "Tritube", and a standard endotracheal tube in patients with predictors of difficult laryngoscopy. The intubation is performed with an angulated video laryngoscope.
Furthermore the investigators compare the acceptance of leaving the Tritube in trachea after end of anaesthesia, with the use of a tube exchange catheter. The latter continues into the post-operative recovery-ward.
244 studies on the registry are indexed under Laryngeal Neoplasms; 63 are open to participants now.
This study's enrollment of 48 is close to the median of 44 across 181 interventional studies indexed under Laryngeal Neoplasms.
Browse Laryngeal Neoplasms studies →This is the only study on the registry with Michael Seltz Kristensen as lead sponsor.
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Exclusion Criteria:
Device: Tritube
Device: Standard enditracheal tube
The ultra thin tribute is used used for the ventilation of the patients in this arm
A standard endotracheal tube is used used for the ventilation of the patients in this arm
Rate of Excellent intubation conditions
Rate of Excellent intubation conditions judged on the scale excellent/good/fair/poor
Time frame: 2 hours
The rate of interruption by the tube of the view to the vocal cords at any time, to such a degree that it disturbs the intubation
Time frame: 2 hours
The Intubation Difficulty Score (IDS)
The intubation difficulty scale , range 0 to 7, 0 indicates easy intubation, 1 - 5 indicates slight difficulty, 5\< indicates moderate to major difficulty
Time frame: 2 hours
Time to intubated
Time from the tube is advanced past the vocal cords until the cuff is inflated in the trachea
Time frame: 2 hours
Time to the patient becomes ventilated via the tube
Time from the tube is advanced past the vocal cords until the cuff is inflated in the trachea and CO2 waveform is observed
Time frame: 2 hours
Number of intubation attempts
one attempt is every-time the tube is advanced past the incisors
Time frame: 2 hours
The rate of succesful intubation with 60 seconds
Time frame: 1 minute
Number of remodellings of the stilette
Time frame: 2 hours
rate of use for "reverse loading" of the tube on the stylet
Time frame: 2 hours
the "percent of glottic opening" , (POGO), Before the tube is inserted
Time frame: 2 hours
the"percent of glottic opening" , POGO, with the tube in place
Time frame: 2 hors
Intubation conditions Strom scale
Direction of the tube-stylet combination excellent/good/poor, easy/fair/difficult. Advancement of the tube-stylet combination excellent/good/poor easy/fair/difficult
Time frame: 2 hours
The surgeons score of the space and working conditions in the mouth/pharynx and larynx after intubation
Time frame: 2 hours
The difference between ET CO2 and arterial blood-gas CO2 after 15 minutes of surgery
Time frame: 20 minutes
the duration of the Tritube being in the trachea after return of spontaneous ventilation and deflation of the cuff /(Tritube group)
Time frame: 4 hours
The duration of the tube-exchange catheter being in the trachea after its placement / (Tube-exchange-catheter group)
Time frame: 4 hours
The ration of patients who still has the Tritube or the tube-exchange-catheter in place when arriving in the post-operative recovery unit
Time frame: 4 hours
The ration of patients who still has the Tritube or the tube-exchange-catheter in place one hour after arrival in the Post anaesthesia care unit the post-operative recovery unit
Time frame: 4 hours
The patient's satisfaction with having the Tritube or the tube-exchange-catheter in place when being awake in the Post anaesthesia care unit
Visual analog scale from 1-10, 1= no nuisance, 10= unberable
Time frame: 4 hours
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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