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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 (Tritube)

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ClinicalTrials.gov Identifier: NCT03653039
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Seltz Kristensen, Rigshospitalet, Denmark

Tracking Information
First Submitted Date  ICMJE August 28, 2018
First Posted Date  ICMJE August 31, 2018
Last Update Posted Date January 7, 2019
Actual Study Start Date  ICMJE September 12, 2018
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2018)
Rate of Excellent intubation conditions [ Time Frame: 2 hours ]
Rate of Excellent intubation conditions judged on the scale excellent/good/fair/poor
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2018)
  • 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 ]
  • 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
  • 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
  • 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
  • Number of intubation attempts [ Time Frame: 2 hours ]
    one attempt is every-time the tube is advanced past the incisors
  • The rate of succesful intubation with 60 seconds [ Time Frame: 1 minute ]
  • Number of remodellings of the stilette [ Time Frame: 2 hours ]
  • rate of use for "reverse loading" of the tube on the stylet [ Time Frame: 2 hours ]
  • the "percent of glottic opening" , (POGO), Before the tube is inserted [ Time Frame: 2 hours ]
  • the"percent of glottic opening" , POGO, with the tube in place [ Time Frame: 2 hors ]
  • 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
  • The surgeons score of the space and working conditions in the mouth/pharynx and larynx after intubation [ Time Frame: 2 hours ]
  • The difference between ET CO2 and arterial blood-gas CO2 after 15 minutes of surgery [ Time Frame: 20 minutes ]
  • 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 ]
  • The duration of the tube-exchange catheter being in the trachea after its placement / (Tube-exchange-catheter group) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 4 hours ]
    Visual analog scale from 1-10, 1= no nuisance, 10= unberable
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomised controlled
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Oral Neoplasm
  • Pharynx Cancer
  • Larynx Cancer
Intervention  ICMJE
  • Device: Tritube
    The ultra thin tribute is used used for the ventilation of the patients in this arm
  • Device: Standard enditracheal tube
    A standard endotracheal tube is used used for the ventilation of the patients in this arm
Study Arms  ICMJE
  • Experimental: Tritube
    Intervention: Device: Tritube
  • Active Comparator: Standard endotracheal tube
    Intervention: Device: Standard enditracheal tube
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 29, 2018)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael S Kristensen, MD 004535458033 michael.seltz.kristensen@regionh.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03653039
Other Study ID Numbers  ICMJE H-18023689 Tritube
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Seltz Kristensen, Rigshospitalet, Denmark
Study Sponsor  ICMJE Michael Seltz Kristensen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael S Kristensen, MD Rigshospitalet, University Hospital of Copenhagen Denmark
PRS Account Rigshospitalet, Denmark
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP