Comparison Between a Standard Tube and the Ultra-thin Tritube for Intubation of the Trachea and for Maintaining Access to the Trachea After Anaesthesia, in Patients With an Expected Difficult Direct Laryngoscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sammenligning Mellem Standard Tube og Den Ultra-tynde Tritube® Til Intubation, og Til Opretholdelse af Adgang Til Trachea Efter anæstesi, Hos Patienter Med Forventet Vanskelig Direkte Laryngoskopi

Conditions
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Oral Neoplasm, Pharynx Cancer, Larynx Cancer

Intervention / Treatment
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* Device: Tritube
* Device: Standard enditracheal tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients for anaesthesia for surgery in the Head-/neck/ear/nose/throat planned for oral intubation with video-laryngoscopy with risk factors for difficult direct laryngoscopy Exclusion Criteria: Patient with increased secretions in the airway (Pneumonia, bronchitis, productive cough) Patients planned for awake intubation Patients where mask-ventilation is judged to could become impossible Patients where access to the cricothyroid membrane is judged to be difficult or impossible Patients in ASA (american Society of Anaesthesiologists) physical classification status >3 Patients who are scheduled for rapid sequence induction (RSI) due to risk of aspiration Patients with stridor Patients with hypoxemia (Saturation < 90 % in room air) Operation duration planned to > 2.5 hours Patients with the need for a nerve-stimulation-tube during surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tritube<br> | Device: Tritube<br>* The ultra thin tribute is used used for the ventilation of the patients in this arm<br>|
| Active Comparator: Standard endotracheal tube<br> | Device: Standard enditracheal tube<br>* A standard endotracheal tube is used used for the ventilation of the patients in this arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Excellent intubation conditions | Rate of Excellent intubation conditions judged on the scale excellent/good/fair/poor | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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 | 2 hours | 
| Time to intubated | Time from the tube is advanced past the vocal cords until the cuff is inflated in the trachea | 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 | 2 hours | 
| Number of intubation attempts | one attempt is every-time the tube is advanced past the incisors | 2 hours | 
| The rate of succesful intubation with 60 seconds |  | 1 minute | 
| Number of remodellings of the stilette |  | 2 hours | 
| rate of use for reverse loading of the tube on the stylet |  | 2 hours | 
| the percent of glottic opening , (POGO), Before the tube is inserted |  | 2 hours | 
| thepercent of glottic opening , POGO, with the tube in place |  | 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 | 2 hours | 
| The surgeons score of the space and working conditions in the mouth/pharynx and larynx after intubation |  | 2 hours | 
| The difference between ET CO2 and arterial blood-gas CO2 after 15 minutes of surgery |  | 20 minutes | 
| the duration of the Tritube being in the trachea after return of spontaneous ventilation and deflation of the cuff /(Tritube group) |  | 4 hours | 
| The duration of the tube-exchange catheter being in the trachea after its placement / (Tube-exchange-catheter group) |  | 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 |  | 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 |  | 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 | 4 hours |