Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Oral Neoplasm Pharynx Cancer Larynx Cancer Device: Tritube Device: Standard enditracheal tube Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : September 12, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tritube Device: Tritube
The ultra thin tribute is used used for the ventilation of the patients in this arm

Active Comparator: Standard endotracheal tube Device: Standard enditracheal tube
A standard endotracheal tube is used used for the ventilation of the patients in this arm




Primary Outcome Measures :
  1. Rate of Excellent intubation conditions [ Time Frame: 2 hours ]
    Rate of Excellent intubation conditions judged on the scale excellent/good/fair/poor


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653039


Contacts
Layout table for location contacts
Contact: Michael S Kristensen, MD 004535458033 michael.seltz.kristensen@regionh.dk

Locations
Layout table for location information
Denmark
Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071 Recruiting
Copenhagen, Denmark, 2100
Contact: Michael S Kristensen, MD    +45 35458033    michael.seltz.kristensen@rh.regionh.dk   
Principal Investigator: Michael S Kristensen, MD         
Sponsors and Collaborators
Michael Seltz Kristensen
Investigators
Layout table for investigator information
Principal Investigator: Michael S Kristensen, MD Rigshospitalet, University Hospital of Copenhagen Denmark

Publications:
Layout table for additonal information
Responsible Party: Michael Seltz Kristensen, Principal Investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03653039    
Other Study ID Numbers: H-18023689 Tritube
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Laryngeal Neoplasms
Pharyngeal Neoplasms
Mouth Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Mouth Diseases