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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)

Primary Purpose

Oral Neoplasm, Pharynx Cancer, Larynx Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Tritube
Standard enditracheal tube
Sponsored by
Michael Seltz Kristensen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oral Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tritube

Standard endotracheal tube

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Time to intubated
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 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
one attempt is every-time the tube is advanced past the incisors
The rate of succesful intubation with 60 seconds
Number of remodellings of the stilette
rate of use for "reverse loading" of the tube on the stylet
the "percent of glottic opening" , (POGO), Before the tube is inserted
the"percent of glottic opening" , POGO, with the tube in place
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
The surgeons score of the space and working conditions in the mouth/pharynx and larynx after intubation
The difference between ET CO2 and arterial blood-gas CO2 after 15 minutes of surgery
the duration of the Tritube being in the trachea after return of spontaneous ventilation and deflation of the cuff /(Tritube group)
The duration of the tube-exchange catheter being in the trachea after its placement / (Tube-exchange-catheter group)
The ration of patients who still has the Tritube or the tube-exchange-catheter in place when arriving in the post-operative recovery unit
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
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

Full Information

First Posted
August 28, 2018
Last Updated
January 4, 2019
Sponsor
Michael Seltz Kristensen
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1. Study Identification

Unique Protocol Identification Number
NCT03653039
Brief Title
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
Acronym
Tritube
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 12, 2018 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Seltz Kristensen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Neoplasm, Pharynx Cancer, Larynx Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tritube
Arm Type
Experimental
Arm Title
Standard endotracheal tube
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Tritube
Intervention Description
The ultra thin tribute is used used for the ventilation of the patients in this arm
Intervention Type
Device
Intervention Name(s)
Standard enditracheal tube
Intervention Description
A standard endotracheal tube is used used for the ventilation of the patients in this arm
Primary Outcome Measure Information:
Title
Rate of Excellent intubation conditions
Description
Rate of Excellent intubation conditions judged on the scale excellent/good/fair/poor
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
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
Title
The Intubation Difficulty Score (IDS)
Description
The intubation difficulty scale , range 0 to 7, 0 indicates easy intubation, 1 - 5 indicates slight difficulty, 5< indicates moderate to major difficulty
Time Frame
2 hours
Title
Time to intubated
Description
Time from the tube is advanced past the vocal cords until the cuff is inflated in the trachea
Time Frame
2 hours
Title
Time to the patient becomes ventilated via the tube
Description
Time from the tube is advanced past the vocal cords until the cuff is inflated in the trachea and CO2 waveform is observed
Time Frame
2 hours
Title
Number of intubation attempts
Description
one attempt is every-time the tube is advanced past the incisors
Time Frame
2 hours
Title
The rate of succesful intubation with 60 seconds
Time Frame
1 minute
Title
Number of remodellings of the stilette
Time Frame
2 hours
Title
rate of use for "reverse loading" of the tube on the stylet
Time Frame
2 hours
Title
the "percent of glottic opening" , (POGO), Before the tube is inserted
Time Frame
2 hours
Title
the"percent of glottic opening" , POGO, with the tube in place
Time Frame
2 hors
Title
Intubation conditions Strom scale
Description
Direction of the tube-stylet combination excellent/good/poor, easy/fair/difficult. Advancement of the tube-stylet combination excellent/good/poor easy/fair/difficult
Time Frame
2 hours
Title
The surgeons score of the space and working conditions in the mouth/pharynx and larynx after intubation
Time Frame
2 hours
Title
The difference between ET CO2 and arterial blood-gas CO2 after 15 minutes of surgery
Time Frame
20 minutes
Title
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
Title
The duration of the tube-exchange catheter being in the trachea after its placement / (Tube-exchange-catheter group)
Time Frame
4 hours
Title
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
Title
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
Title
The patient's satisfaction with having the Tritube or the tube-exchange-catheter in place when being awake in the Post anaesthesia care unit
Description
Visual analog scale from 1-10, 1= no nuisance, 10= unberable
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael S Kristensen, MD
Phone
004535458033
Email
michael.seltz.kristensen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Kristensen, MD
Organizational Affiliation
Rigshospitalet, University Hospital of Copenhagen Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael S Kristensen, MD
Phone
+45 35458033
Email
michael.seltz.kristensen@rh.regionh.dk
First Name & Middle Initial & Last Name & Degree
Michael S Kristensen, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
17635389
Citation
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.
Results Reference
background
PubMed Identifier
28436022
Citation
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.
Results Reference
background
PubMed Identifier
25982220
Citation
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.
Results Reference
background

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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

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