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 Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tritube
|
Device: Tritube
The ultra thin tribute is used used for the ventilation of the patients in this arm
|
| Active Comparator: Standard endotracheal tube
|
Device: Standard enditracheal tube
A standard endotracheal tube is used used for the ventilation of the patients in this arm
|
Outcome Measures
Primary Outcome Measures
- Rate of Excellent intubation conditions [2 hours]
Rate of Excellent intubation conditions judged on the scale excellent/good/fair/poor
Secondary Outcome Measures
- 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) [2 hours]
The intubation difficulty scale , range 0 to 7, 0 indicates easy intubation, 1 - 5 indicates slight difficulty, 5< indicates moderate to major difficulty
- Time to intubated [2 hours]
Time from the tube is advanced past the vocal cords until the cuff is inflated in the trachea
- Time to the patient becomes ventilated via the tube [2 hours]
Time from the tube is advanced past the vocal cords until the cuff is inflated in the trachea and CO2 waveform is observed
- Number of intubation attempts [2 hours]
one attempt is every-time the tube is advanced past the incisors
- 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]
- the"percent of glottic opening" , POGO, with the tube in place [2 hors]
- Intubation conditions Strom scale [2 hours]
Direction of the tube-stylet combination excellent/good/poor, easy/fair/difficult. Advancement of the tube-stylet combination excellent/good/poor easy/fair/difficult
- 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 [4 hours]
Visual analog scale from 1-10, 1= no nuisance, 10= unberable
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients for anaesthesia for surgery in the Head-/neck/ear/nose/throat
-
planned for oral intubation with video-laryngoscopy
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with risk factors for difficult direct laryngoscopy
Exclusion Criteria:
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Patient with increased secretions in the airway (Pneumonia, bronchitis, productive cough)
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Patients planned for awake intubation
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Patients where mask-ventilation is judged to could become impossible
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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
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Patients who are scheduled for rapid sequence induction (RSI) due to risk of aspiration
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Patients with stridor
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Patients with hypoxemia (Saturation < 90 % in room air)
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Operation duration planned to > 2.5 hours
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Patients with the need for a nerve-stimulation-tube during surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071 | Copenhagen | Denmark | 2100 |
Sponsors and Collaborators
- Michael Seltz Kristensen
Investigators
- Principal Investigator: Michael S Kristensen, MD, Rigshospitalet, University Hospital of Copenhagen Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Kristensen MS, de Wolf MWP, Rasmussen LS. Ventilation via the 2.4 mm internal diameter Tritube(®) 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. Review.
- Strøm C, Barnung S, Kristensen MS, Bøttger 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.
- H-18023689 Tritube