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Trial registered on ANZCTR


Registration number
ACTRN12619000425190
Ethics application status
Approved
Date submitted
8/03/2019
Date registered
15/03/2019
Date last updated
22/08/2019
Date data sharing statement initially provided
15/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of a new direct wire-guided oral intubation device
Scientific title
Effect of using a direct wire-guided tracheal intubation system on oral intubation
Secondary ID [1] 297680 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Airway management 311959 0
Condition category
Condition code
Anaesthesiology 310537 310537 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Assessment of a new wire-guided endotracheal tube (ETT).
Our hypothesis is that this device will provide reproducible railroading of the ETT over the guidewire, with minimal hold-up and a very low rate of endotracheal tube impingement on entering the glottic inlet. This will therefore provide reliable and atraumatic endotracheal intubation.
This ETT is designed to have the same rate of deformation as the guidewire over which it will be passed, with the channel for the guidewire located within the wall of the ETT. Traditional introducers/bougies are passed through the glottic inlet, and then an ETT is passed (railroaded) over the introducer. This is a standard (and commonly used) technique in anaesthesia practice, however it has its drawbacks - namely there is often a gap between the introducer and the ETT due to differences in the diameters of the introducer and the ETT lumen. This can result in the ETT catching on laryngeal (or other) structures during the railroading process, and potentially results in tissue trauma. The non-kinking guidewire in this new system acts as an introducer, but the design reduces issues relating to the gap between traditional 'introducers/bougies' and the ETT. We hypothesise that this, along with the ETT's soft silicone tip, will help to minimise ETT 'hold-up' and tissue trauma. Additionally, because the rate of deformation of the ETT matches the rate of deformation of the guidewire we also hypothesise that it will reduce the risk of ETT misplacement.
The system (ETT and guidewire) will be used in patients who require an endotracheal tube for their surgery. The procedure will involve using a Karl Storz C-Mac D-blade to insert an adequate length of the guidewire in the trachea, and then railroading the ETT from the oropharynx (under vision) into the trachea, and confirming correct placement via standard methods.
The study will be conducted at Royal Hobart Hospital by a small group of consultant anaesthetists, with recruitment of 300 patients expected to take approximately 2 years. Elective surgery patients will be screened on upcoming operating lists and recruited on lists involving the study anaesthetists (investigators).
With regard to "strategies used to assess or monitor fidelity...[of]...the intervention", we have a departmental research nurse who will be involved in observing the procedures and in data collection. Apart from following the study protocol and recording the information on a specific Case Record Form for each procedure, there are no other specific strategies relaying to this.
Intervention code [1] 313912 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319398 0
The rate of significant ETT tip impingement (defined as obstruction while passing the ETT through the glottic inlet into the trachea, not relieved by withdrawal and rotation of the tube), as graded by the experienced anaesthetist performing the procedure (direct observation).

This will be assessed based on the ease, or otherwise, with which the ETT is railroaded over the wire. If the ETT passes easily with no difficulty, or if it encounters some resistance but this is overcome by simply withdrawing the ETT, and rotating it, then this will not be classified as "significant impingement". Anything other than these 2 relatively minor issues will be classified as "significant impingement".
Timepoint [1] 319398 0
Immediate - at time of intubation
Secondary outcome [1] 368016 0
Grading of difficulty of passage of the ETT through the laryngeal inlet using a 4 point scale:
1) No difficulty;
2) Obstruction while passing the tracheal tube, relieved by withdrawal and rotation of the tube;
3) Obstruction necessitating more than one manipulation, including external laryngeal manipulation;
4) Direct laryngoscopy required to insert tracheal tube.
Timepoint [1] 368016 0
Immediate - at time of intubation
Secondary outcome [2] 368017 0
Resistance during passage of ETT (graded as mild, moderate or severe).

This will be graded subjectively by the experienced anaesthetist performing the procedure (direct observation).
Timepoint [2] 368017 0
Immediate - at time of intubation
Secondary outcome [3] 368018 0
Prevalence of oesophageal intubation.

This is a composite outcome determined by some or all of the following (as judged clinically by the experienced anaesthetist performing the procedure): absence of normal capnography and chest movement, confirmed by videolaryngoscopy and chest auscultation.
Timepoint [3] 368018 0
Immediate - at time of intubation
Secondary outcome [4] 368019 0
Composite endpoint of all events recorded as an airway injury (judged using direct observation by the treating anaesthetist):
- visible lip abrasion;
- visible dental damage to enamel;
- vocal cord injury (vocal cord abrasion or reduced movement or function);
- tracheobronchial injury (abrasion or bleeding);
- injury to digestive tract (abrasion or bleeding);
- hoarseness (present in recovery 30 minutes after arrival);
- sore throat (painful, not just scratchy, present in recovery 30 minutes after arrival).
Timepoint [4] 368019 0
30 minutes after arrival in recovery
Secondary outcome [5] 368020 0
Intubation time (defined as time from removal of face mask until ETT cuff inflated and correct positioning confirmed by capnography).

This will be assessed by direct observation using a stopwatch/timer on the anaesthetic machine, and will be reported by the anaesthetist performing the procedure.
Timepoint [5] 368020 0
Immediate - at time of intubation
Secondary outcome [6] 368021 0
Lowest oxygen saturation during intubation process (from removal of face mask until ETT cuff inflated and correct position confirmed by capnography).

This will be assessed by reviewing the lowest oxygen saturation (measured using a pulse oximeter) recorded or noted on the anaesthetic monitor.
Timepoint [6] 368021 0
Immediate - at time of intubation

Eligibility
Key inclusion criteria
- ASA 1 –3;
- older than 18 years of age;
- fasted at least 6 hours for solids and 2 hours for clear liquids;
- undergoing elective procedures requiring endotracheal intubation with an expected easy intubation.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- predicted difficult intubation;
- predicted difficult bag-mask ventilation;
- morbid obesity (BMI> 35);
- significant pulmonary disease;
- decreased cervical spine mobility;
- known pathology or previous major surgery in the mouth, pharynx or larynx;
- patients where a ‘rapid sequence’ or ‘modified rapid sequence’ induction is deemed clinically appropriate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Considering an anticipated endotracheal tip impingement rate of 1 % with a precision of 1.5% of the point estimate, and 99% confidence to ensure the upper limit of the failure rate is = 2.5%, the calculated sample size is 292. The study size has been determined with consideration that many studies are underpowered to show the required precision with an appropriately low failure rate. We intend to recruit 300 patients.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 13348 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 25947 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 302206 0
Hospital
Name [1] 302206 0
Royal Hobart Hospital
Address [1] 302206 0
Department of Anaesthesia & Perioperative Medicine,
Level 4, H Block,
Royal Hobart Hospital,
48 Liverpool Street, Hobart, TASMANIA, 7000
Country [1] 302206 0
Australia
Funding source category [2] 302242 0
Self funded/Unfunded
Name [2] 302242 0
Dr Sasanka Dhara
Address [2] 302242 0
Department of Anaesthesia & Perioperative Medicine,
Level 4, H Block,
Royal Hobart Hospital,
48 Liverpool Street, Hobart, TASMANIA, 7000
Country [2] 302242 0
Australia
Primary sponsor type
Individual
Name
Dr Michael Challis
Address
Department of Anaesthesia & Perioperative Medicine,
Level 4, H Block,
Royal Hobart Hospital,
48 Liverpool Street, Hobart, TASMANIA, 7000
Country
Australia
Secondary sponsor category [1] 302053 0
Individual
Name [1] 302053 0
Dr Sasanka Dhara
Address [1] 302053 0
Department of Anaesthesia & Perioperative Medicine,
Level 4, H Block,
Royal Hobart Hospital,
48 Liverpool Street, Hobart, TASMANIA, 7000
Country [1] 302053 0
Australia
Other collaborator category [1] 280586 0
Individual
Name [1] 280586 0
Dr Danny McGlone
Address [1] 280586 0
Department of Anaesthesia & Perioperative Medicine,
Level 4, H Block,
Royal Hobart Hospital,
48 Liverpool Street, Hobart, TASMANIA, 7000
Country [1] 280586 0
Australia
Other collaborator category [2] 280587 0
Individual
Name [2] 280587 0
Dr Tom Mohler
Address [2] 280587 0
Department of Anaesthesia & Perioperative Medicine,
Level 4, H Block,
Royal Hobart Hospital,
48 Liverpool Street, Hobart, TASMANIA, 7000
Country [2] 280587 0
Australia
Other collaborator category [3] 280588 0
Individual
Name [3] 280588 0
Dr Savas Totonidis
Address [3] 280588 0
Department of Anaesthesia & Perioperative Medicine,
Level 4, H Block,
Royal Hobart Hospital,
48 Liverpool Street, Hobart, TASMANIA, 7000
Country [3] 280588 0
Australia
Other collaborator category [4] 280589 0
Individual
Name [4] 280589 0
Dr Craig Young
Address [4] 280589 0
Department of Anaesthesia & Perioperative Medicine,
Level 4, H Block,
Royal Hobart Hospital,
48 Liverpool Street, Hobart, TASMANIA, 7000
Country [4] 280589 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302885 0
Tasmania Health and Medical Human Research Ethics Committee
Ethics committee address [1] 302885 0
Office of Research Services
University of Tasmania
Private Bag 1
Hobart, TAS, 7001
Ethics committee country [1] 302885 0
Australia
Date submitted for ethics approval [1] 302885 0
25/05/2016
Approval date [1] 302885 0
21/09/2016
Ethics approval number [1] 302885 0
H0015791

Summary
Brief summary
An endotracheal tube (ETT) is used to safely and securely manage a patient's airway during anaesthesia. Sometimes these can be difficult to insert, requiring the use of an introducer - something smaller and solid that fits inside the ETT, and is easier to insert into the trachea ('wind pipe') than the tube initially. One of the problems that exists with this technique is that any gap between the ETT and the introducer can lead to the ETT getting caught on structures around the vocal cords as it is railroaded over the introducer.
Our study uses a novel ETT/guidewire system that was developed to overcome these problems. The ETT has a channel for the guidewire in its wall, and the rate of deformation of the ETT matches the rate of deformation of the guidewire. This allows the ETT to follow the path of the guidewire easily.
We will use an accepted technique of visualising the vocal cords (using a video laryngoscope) to pass the guidewire into the 'wind pipe', and then railroad the ETT over the guidewire under vision.
Our hypothesis is that this system will have a very low rate of ETT hold-up or impingement on entering the 'wind pipe', and therefore provide reliable and atraumatic intubation.
We will record the incidence of all complications, including trauma to any airway structures, misplacement of the tube, difficulty placing the tube in the 'wind pipe', problems with oxygen levels during the procedure, and the time taken for the procedure.
We expect the system to be very effective and reliable, based on preliminary studies on manikins and cadavers, and also based on one human study done overseas using this system.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91734 0
Dr Michael Challis
Address 91734 0
Department of Anaesthesia & Perioperative Medicine
level 4, H Block
Royal Hobart Hospital
48 Liverpool Street, Hobart, TASMANIA, 7000
Country 91734 0
Australia
Phone 91734 0
+61 3 6166 8523
Fax 91734 0
+61 3 6173 0408
Email 91734 0
michael.challis@ths.tas.gov.au
Contact person for public queries
Name 91735 0
Dr Michael Challis
Address 91735 0
Department of Anaesthesia & Perioperative Medicine
level 4, H Block
Royal Hobart Hospital
48 Liverpool Street, Hobart, TASMANIA, 7000
Country 91735 0
Australia
Phone 91735 0
+61 3 6166 8523
Fax 91735 0
+61 3 6173 0408
Email 91735 0
michael.challis@ths.tas.gov.au
Contact person for scientific queries
Name 91736 0
Dr Michael Challis
Address 91736 0
Department of Anaesthesia & Perioperative Medicine
level 4, H Block
Royal Hobart Hospital
48 Liverpool Street, Hobart, TASMANIA, 7000
Country 91736 0
Australia
Phone 91736 0
+61 3 6166 8523
Fax 91736 0
+61 3 6173 0408
Email 91736 0
michael.challis@ths.tas.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Summarised data will be presented after patient data is de-identified and stored. This is to comply with privacy regulations.
What supporting documents are/will be available?
No other documents available
Summary results
No Results