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

Larynx Cancer Clinical Trial

— Tritube  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03653039
• Other study ID #: H-18023689 Tritube
• Status: Completed
• Phase: N/A
• Start date: September 12, 2018
• Est. completion date: February 14, 2019

Study information

• Verified date: February 2024
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 14, 2019
• Est. primary completion date: February 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laryngeal Neoplasms
• Larynx Cancer
• Mouth Neoplasms
• Oral Neoplasm
• Pharyngeal Neoplasms
• Pharynx Cancer

Intervention

Device:
• Tritube
The ultra thin tribute is used used for the ventilation of the patients in this arm
• Standard enditracheal tube
A standard endotracheal tube is used used for the ventilation of the patients in this arm

Locations

Country	Name	City	State
Denmark	Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Michael Seltz Kristensen

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

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