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Oral NeoplasmTritubeNCT03653039

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

A study testing Tritube and Standard enditracheal tube in people with Oral Neoplasm and Pharynx Cancer, run by Michael Seltz Kristensen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oral Neoplasm, Pharynx Cancer, Larynx Cancer
What is being tested?
Tritube and Standard enditracheal tube
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteDenmark
Study dates
12 Sep 2018to 14 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

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

    Copenhagen, 2100

Other trials in Denmark

About this study

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

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.

Read the 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.

Being tested
Tritube, Standard enditracheal tube
Medical subject headings
Mouth Neoplasms, Pharyngeal Neoplasms, Laryngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TritubeDevice

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

  • Standard enditracheal tubeDevice

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

Study groups in NCT03653039
Study groupRoleWhat they receive
TritubeExperimentalNot described
Receives: Device: Tritube
Standard endotracheal tubeActive comparatorNot described
Receives: Device: Standard enditracheal tube

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Excellent intubation conditions

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

    Measured: 2 hours

Secondary outcomes (18)

  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

    Measured: 2 hours

  2. 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

    Measured: 2 hours

  3. Time to intubated

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

    Measured: 2 hours

  4. 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

    Measured: 2 hours

  5. Number of intubation attempts

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

    Measured: 2 hours

  6. The rate of succesful intubation with 60 seconds

    Measured: 1 minute

  7. Number of remodellings of the stilette

    Measured: 2 hours

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

    Measured: 2 hours

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

    Measured: 2 hours

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

    Measured: 2 hors

  11. 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

    Measured: 2 hours

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

    Measured: 2 hours

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

    Measured: 20 minutes

  14. the duration of the Tritube being in the trachea after return of spontaneous ventilation and deflation of the cuff /(Tritube group)

    Measured: 4 hours

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

    Measured: 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

    Measured: 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

    Measured: 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

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

    Measured: 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2018
  2. Study start12 Sep 2018
  3. Primary completion14 Feb 2019
  4. Study completion14 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised controlled
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03653039
Sponsor's protocol ID
H-18023689 Tritube
Acronym
Tritube
Status last verified
Feb 2024
First submitted
28 Aug 2018
Last updated
29 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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. doi: 10.1111/j.1399-6576.2007.01352.x.

    PubMed 17635389

  • 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.

    PubMed 28436022

  • 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.

    PubMed 25982220

Questions about this trial

What is this clinical trial studying?

A study testing Tritube and Standard enditracheal tube in people with Oral Neoplasm and Pharynx Cancer, run by Michael Seltz Kristensen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Excellent intubation conditions (time frame: 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03653039, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.

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