Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Oral Neoplasm Head and Neck Neoplasms Laryngeal Diseases Laryngeal Neoplasms Larynx Cancer Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Pharynx Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tritube

Device

The ultra thin tribute is used used for the ventilation of the patients in this arm

Standard enditracheal tube

Device

A standard endotracheal tube is used used for the ventilation of the patients in this arm

Primary outcomes

  1. Rate of Excellent intubation conditions

    Time frame: 2 hours

    Rate of Excellent intubation conditions judged on the scale excellent/good/fair/poor

Secondary outcomes

  1. 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

  2. The Intubation Difficulty Score (IDS)

    Time frame: 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

  3. Time to intubated

    Time frame: 2 hours

    Time from the tube is advanced past the vocal cords until the cuff is inflated in the trachea

  4. Time to the patient becomes ventilated via the tube

    Time frame: 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

  5. Number of intubation attempts

    Time frame: 2 hours

    one attempt is every-time the tube is advanced past the incisors

  6. The rate of succesful intubation with 60 seconds

    Time frame: 1 minute

  7. Number of remodellings of the stilette

    Time frame: 2 hours

  8. rate of use for "reverse loading" of the tube on the stylet

    Time frame: 2 hours

  9. the "percent of glottic opening" , (POGO), Before the tube is inserted

    Time frame: 2 hours

  10. the"percent of glottic opening" , POGO, with the tube in place

    Time frame: 2 hors

  11. Intubation conditions Strom scale

    Time frame: 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

  12. The surgeons score of the space and working conditions in the mouth/pharynx and larynx after intubation

    Time frame: 2 hours

  13. The difference between ET CO2 and arterial blood-gas CO2 after 15 minutes of surgery

    Time frame: 20 minutes

  14. 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

  15. The duration of the tube-exchange catheter being in the trachea after its placement / (Tube-exchange-catheter group)

    Time frame: 4 hours

  16. 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

  17. 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

  18. The patient's satisfaction with having the Tritube or the tube-exchange-catheter in place when being awake in the Post anaesthesia care unit

    Time frame: 4 hours

    Visual analog scale from 1-10, 1= no nuisance, 10= unberable

Sponsors and collaborators

Lead sponsor

Michael Seltz Kristensen

Other

Registry information

Official study 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

Acronym: Tritube

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 31, 2018
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.