NCT03653039

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

September 12, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2019

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

August 28, 2018

Last Update Submit

February 28, 2024

Conditions

Oral NeoplasmPharynx CancerLarynx Cancer

Outcome Measures

Primary Outcomes (1)

  • Rate of Excellent intubation conditions

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

    2 hours

Secondary Outcomes (18)

  • 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

  • Time to intubated

    2 hours

  • Time to the patient becomes ventilated via the tube

    2 hours

  • Number of intubation attempts

    2 hours

  • +13 more secondary outcomes

Study Arms (2)

Tritube

EXPERIMENTAL
Device: Tritube

Standard endotracheal tube

ACTIVE COMPARATOR
Device: Standard enditracheal tube

Interventions

TritubeDEVICE

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

Tritube
Standard enditracheal tubeDEVICE

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

Standard endotracheal tube

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Copenhagen, 2100, Denmark

Location

Related 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.

    PMID: 17635389BACKGROUND

  • 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.

    PMID: 28436022BACKGROUND

  • 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.

    PMID: 25982220BACKGROUND

MeSH Terms

Conditions

Mouth NeoplasmsPharyngeal NeoplasmsLaryngeal Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesOtorhinolaryngologic NeoplasmsPharyngeal DiseasesOtorhinolaryngologic DiseasesLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract Neoplasms

Study Officials

  • Michael S Kristensen, MD

    Rigshospitalet, University Hospital of Copenhagen Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomised controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 28, 2018

First Posted

August 31, 2018

Study Start

September 12, 2018

Primary Completion

February 14, 2019

Study Completion

February 14, 2019

Last Updated

February 29, 2024

Record last verified: 2024-02

Locations

DK(1)