Clinical trial NCT03653039: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Neoplasm
Pharynx Cancer
Larynx Cancer
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Excellent intubation conditions
timeFrame: 2 hours
Secondary outcomes:
measure: 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
timeFrame: 2 hours
measure: The Intubation Difficulty Score (IDS)
timeFrame: 2 hours
measure: Time to intubated
timeFrame: 2 hours
measure: Time to the patient becomes ventilated via the tube
timeFrame: 2 hours
measure: Number of intubation attempts
timeFrame: 2 hours
measure: The rate of succesful intubation with 60 seconds
timeFrame: 1 minute
measure: Number of remodellings of the stilette
timeFrame: 2 hours
measure: rate of use for "reverse loading" of the tube on the stylet
timeFrame: 2 hours
measure: the "percent of glottic opening" , (POGO), Before the tube is inserted
timeFrame: 2 hours
measure: the"percent of glottic opening" , POGO, with the tube in place
timeFrame: 2 hors
measure: Intubation conditions Strom scale
timeFrame: 2 hours
measure: The surgeons score of the space and working conditions in the mouth/pharynx and larynx after intubation
timeFrame: 2 hours
measure: The difference between ET CO2 and arterial blood-gas CO2 after 15 minutes of surgery
timeFrame: 20 minutes
measure: the duration of the Tritube being in the trachea after return of spontaneous ventilation and deflation of the cuff /(Tritube group)
timeFrame: 4 hours
measure: The duration of the tube-exchange catheter being in the trachea after its placement / (Tube-exchange-catheter group)
timeFrame: 4 hours
measure: The ration of patients who still has the Tritube or the tube-exchange-catheter in place when arriving in the post-operative recovery unit
timeFrame: 4 hours
measure: 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
timeFrame: 4 hours
measure: The patient's satisfaction with having the Tritube or the tube-exchange-catheter in place when being awake in the Post anaesthesia care unit
timeFrame: 4 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071
Study officials:
affiliation: Rigshospitalet, University Hospital of Copenhagen Denmark
name: Michael S Kristensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.
citation: Kristensen MS, de Wolf MWP, Rasmussen LS. Ventilation via the 2.4 mm internal diameter Tritube(R) with cuff - new possibilities in airway management. Acta Anaesthesiol Scand. 2017 Jul;61(6):580-589. doi: 10.1111/aas.12894. Epub 2017 Apr 23.
citation: Strom C, Barnung S, Kristensen MS, Bottger M, Tvede MF, Rasmussen LS. Tracheal intubation in patients with anticipated difficult airway using Boedeker intubation forceps and McGrath videolaryngoscope. Acta Anaesthesiol Scand. 2015 Oct;59(9):1154-60. doi: 10.1111/aas.12543. Epub 2015 May 16.