Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000320853
Ethics application status
Approved
Date submitted
23/02/2021
Date registered
22/03/2021
Date last updated
30/06/2022
Date data sharing statement initially provided
22/03/2021
Date results information initially provided
30/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the extubation force resisted by different methods of securing an endotracheal tube placed via a surgical cricothyroidotomy by emergency physicians: A double-blind randomised controlled trial in cadavers.
Scientific title
A comparison of methods to secure an endotracheal tube cricothyroidotomy: A double-blind randomised controlled trial in cadavers.
Secondary ID [1] 303535 0
Nil known
Universal Trial Number (UTN)
U1111-1265-2820
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Difficult airway 320865 0
Can't intubate can't oxygenate (CICO) scenario 320866 0
Condition category
Condition code
Emergency medicine 318683 318683 0 0
Resuscitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A novel method of tying an endotracheal tube (ETT) using a fabric twill tape will be used to secure an ETT placed through the cricothyroidotomy (surgical airway) in cadavers. The technique involves a series of square knots to ensure the tape cannot alter it's length (as it is around the neck) whilst also tightly securing the ETT (to prevent inadvertent extubation). This method will be taught to candidates participating on a cadaveric airway course for critical care clinicians.
Intervention description:
a) The intervention will be taught by the authors of the study (senior emergency physicians and directors of the cadaveric airway course).
b) The teaching intervention is brief - less than 10 minutes per technique
c) The participants are observed by the study authors whilst performing the techniques and guidance will be available if difficulty is encountered.
Regarding washout - the order of techniques will be randomised for each participant and they will undertake each procedure on a different cadaver. The washout period is the time taken to move to the next cadaver.
Intervention code [1] 319816 0
Treatment: Other
Comparator / control treatment
A standard method of tying an endotracheal tube (ETT) using a fabric twill tape will be used to secure an ETT placed through the cricothyroidotomy (surgical airway) in cadavers. The technique involves a Lark's foot knot to ensure the tape cannot alter it's length (as it is around the neck) whilst also tightly securing the ETT (to prevent inadvertent extubation). This method will be taught to candidates participating on a cadaveric airway course for critical care clinicians.
Intervention description:
a) The intervention is taught by the authors of the study (senior emergency physicians and directors of the cadaveric airway course).
b) The teaching intervention is brief - less than 10 minutes per technique
c) The participants are observed by the study authors whilst performing the techniques and guidance will be available if difficulty is encountered.
Control group
Active

Outcomes
Primary outcome [1] 326629 0
Longitudinal force required to extubate (remove the ETT from the airway) as measure using a digital force scale. The investigator will be blinded to the securing method used by way of a fenestrated drape that conceals the knot.
Timepoint [1] 326629 0
After the securing procedure is complete.
Secondary outcome [1] 392204 0
Ease of securing the ETT as assessed by visual analogue scale completed by the participant.
Timepoint [1] 392204 0
After completing the securing technique.

Eligibility
Key inclusion criteria
Emergency physician attending the cadaveric airway course.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who do not feel confident in knot tying (although this is unlikely in a group of critical care clinicians attending a cadaveric airway course).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants undertake both techniques in random order.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomisation to randomise the sequence of techniques and order of participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For a clinically significant difference of 200g force leading to extubation, assuming a standard deviation (difference in extubating force between techniques) less than or equal to the clinically significant mean difference i.e. 200g. Alpha of 0.05 and Power of 0.8
Sample size = 20.
The statistical significance of these measures will be tested using paired statistical testing procedures, i.e. paired Student’s t-test, Wilcoxon Signed Rank Test or McNemars test, respectively, as appropriate depending on data symmetry. P values < 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/06/2021
Actual
9/06/2021
Date of last participant enrolment
Anticipated
Actual
9/06/2021
Date of last data collection
Anticipated
Actual
9/06/2021
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 307958 0
Hospital
Name [1] 307958 0
Alfred Health
Country [1] 307958 0
Australia
Primary sponsor type
Hospital
Name
Emergency & Trauma Centre, The Alfred Hospital
Address
The Alfred Hospital
Commercial Road
Melbourne, VIC 3000
Country
Australia
Secondary sponsor category [1] 308672 0
None
Name [1] 308672 0
Address [1] 308672 0
Country [1] 308672 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307947 0
The University of Melbourne Human Ethics Advisory Group
Ethics committee address [1] 307947 0
The University of Melbourne Human Ethics Advisory Group
Office of Research Ethics and Integrity (OREI)
The University of Melbourne
1/21 Bedford St
North Melbourne
Victoria
AUSTRALIA 3010
Ethics committee country [1] 307947 0
Australia
Date submitted for ethics approval [1] 307947 0
30/09/2020
Approval date [1] 307947 0
01/10/2020
Ethics approval number [1] 307947 0
2058001

Summary
Brief summary
In this study we have chosen to compare two methods to secure an endotracheal tube placed via a surgical airway (cricothyroidotomy). Whilst there are numerous descriptions in the literature about how to undertake the technique of cricothyroidotomy there is a paucity of evidence regarding the best methods to prevent inadvertent extubation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109022 0
Dr Christopher Groombridge
Address 109022 0
The National Trauma Research Institute
Alfred Health
Commercial Road
Melbourne
Victoria
3004
Country 109022 0
Australia
Phone 109022 0
+61 390763405
Fax 109022 0
Email 109022 0
[email protected]
Contact person for public queries
Name 109023 0
Dr Christopher Groombridge
Address 109023 0
The National Trauma Research Institute
Alfred Health
Commercial Road
Melbourne
Victoria
3004
Country 109023 0
Australia
Phone 109023 0
+61 390763405
Fax 109023 0
Email 109023 0
[email protected]
Contact person for scientific queries
Name 109024 0
Dr Christopher Groombridge
Address 109024 0
The National Trauma Research Institute
Alfred Health
Commercial Road
Melbourne
Victoria
3004
Country 109024 0
Australia
Phone 109024 0
+61 390763405
Fax 109024 0
Email 109024 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Analysed data will be submitted for publication.
Individual participant data will not be made available in order to maintain the privacy of the small sample of physicians from this single centre airway course.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Groombridge CJ, Maini A, Mathew J, Kim Y, Fitzgera... [More Details]
Plain language summaryNo Following a surgical cricothyroidotomy in fresh fr... [More Details]

Documents added automatically
No additional documents have been identified.