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Trial registered on ANZCTR


Registration number
ACTRN12613000911796
Ethics application status
Approved
Date submitted
10/06/2013
Date registered
15/08/2013
Date last updated
15/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial comparing the effectiveness of standard teaching methods and new teaching methods for anaesthetic registrars on how to manage a 'Can't intubate Can't Ventilate' (CICV) scenario
Scientific title
A randomised controlled trial comparing the effectiveness of standard teaching methods and new teaching methods for anaesthetic registrars on how to manage a 'Can't intubate Can't Ventilate' (CICV) scenario
Secondary ID [1] 282645 0
CMDHB trial number 1177
Universal Trial Number (UTN)
U1111-1144-1905
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Can not intubate can not ventilate scenarios 289347 0
Condition category
Condition code
Anaesthesiology 289684 289684 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Registrars randomised to the intervention group will receive both the standard teaching and the new teaching methods for management of a 'Can't Intubate Can't Ventilate' (CICV) scenario. The standard teaching method involves teaching 2 different techniques using airway models. The two different techniques taught are: 1. Needle Cricothyrotomy: A cricothyrotomy is a needle placed through the skin and cricothyroid membrane to establish a means to oxygenate the patient during certain life-threatening situations, such as airway obstruction by a foreign body, angioedema, or massive facial trauma. Cricothyrotomy is nearly always performed as a last resort in cases where or tracheal and nasotracheal intubation are impossible or contraindicated, and ventilation is impossible. Cricothyrotomy is easier and quicker to perform than tracheotomy, does not require manipulation of the cervical spine, and is associated with fewer complications. However, while cricothyrotomy may be life-saving in extreme circumstances; this technique is only intended to be a temporizing measure until a definitive airway can be established. 2. Surgical Cric: Surgical cricothyroidotomy is an emergent airway approach in which the clinician makes an incision in the cricothyroid membrane and passes a tracheotomy or endotracheal tube into the trachea. The four step technique is a recognized method of surgical cricothyroidotomy. The new teaching method will involve random spontaneous testing with feedback on these 2 different techniques over a 6 month period. Both groups will be reassessed by blinded assessors at baseline, 6 months and 12 months.
Intervention code [1] 287313 0
Other interventions
Comparator / control treatment
The control group will receive the standard teaching method for management of a 'Can't Intubate Can't Ventilate' scenario. The control group will be reassessed by blinded assessors at baseline, 6 months and 12 months. The standard teaching method takes approximately 3 hours.
Control group
Active

Outcomes
Primary outcome [1] 289771 0
Time to perform a needle cricothyroidotomy assessed with a stopwatch
Timepoint [1] 289771 0
At time 12 months.
Primary outcome [2] 290195 0
Time to perform a surgical airway assessed with a stop watch.
Timepoint [2] 290195 0
12 months
Secondary outcome [1] 303212 0
Global rating scores(GRS). We will be using the GRS developed by S.Boet (BJA 107(4): 533-9 (2011)). The GRS is a method of assessing how efficiently the procedure was completed.
Timepoint [1] 303212 0
At time 0 and 6 months and 12 months
Secondary outcome [2] 303347 0
Task specific check list(TCL). We will be using the TCL developed by S.Boet (BJA 107(4): 533-9 (2011)). The TCL is a method of assessing how methodically the procedure was completed.
Timepoint [2] 303347 0
At time 0 and 6 and 12 months

Eligibility
Key inclusion criteria
Anaesthetic registrars with greater than 6 months anaesthetic experience.
Minimum age
23 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
less than 6 months anaesthesia.
if leaving NZ in less than one year

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The recruitment, assessment and intervention will occur in two waves 6 months apart. The recruitment wave will be included as a fixed effect in all analyses, and removed if non-significant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation
Stratified block randomisation will be used to allocate participants into one of the two intervention arms. The strata will consist of the waves, and the permuted blocks within the strata will have random block sizes of undisclosed size. The randomisation schedule will be generated using computer code written by the study statistician and based on the standard pseudo-random number generator used in the R software (v 3.0.0) with seed set using the decimal part of the seconds reading in the system time.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
none
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Primary analyses will consist in fitting separate ANCOVA models to each primary outcome using baseline outcome values as continuous covariates and intervention group as factor, using the ITT analysis set. P-values will be adjusted for false discovery rate control at 5% and confidence intervals about the effect sizes computed based on a false coverage rate of 95% to adjust for the multiplicity. The primary alternative hypothesis will be selected if both adjusted p-values reach the significance threshold with both primary outcomes being improved on average.

Secondary analyses will consist in a repetition of the primary analysis in the PP set and also for the secondary outcomes in the ITT set.

Sample size computation:
The minimal clinically important difference (MCID) is set at 30 for both procedures. A standard deviation of 36 seconds is assumed for both procedures, based on data from the literature (Ref BJA 2011: 107:533-9 and Anaesthesia 2007 oct) on needle cricothyrotomy whose time to completion is more variable than surgical cricothyrotomy. Assuming a conservative correlation figure of 0.3 between baseline and outcome and a reasonable design effect of 1.1 due to the clustering (wave) variable, we will require 23 participants in each group to detect the MCID with 80% power at the stated significance level. Assuming a 10% attrition fraction, we will seek to recruit 26 participants per arm, for a total of 52.

Recruitment
Recruitment status
Not yet 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 outside Australia
Country [1] 5136 0
New Zealand
State/province [1] 5136 0
Auckland

Funding & Sponsors
Funding source category [1] 287425 0
Hospital
Name [1] 287425 0
Middlemore Hospital, Dept Anaesthesia.
Address [1] 287425 0
Dept Anaesthesia, Middlemore Hospital, 100 Hospital Road, Otahuhu, Auckland, 1640 New Zealand
Country [1] 287425 0
New Zealand
Primary sponsor type
Hospital
Name
Middlemore Hospital
Address
Dept Anaestheisa, middlmore hospital, 100 Hospital Road, Otahuhu, auckland 1640.
Country
New Zealand
Secondary sponsor category [1] 286484 0
None
Name [1] 286484 0
Address [1] 286484 0
Country [1] 286484 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289406 0
Northern X Regional Ethics Commitee
Ethics committee address [1] 289406 0
Health and Disability Ethics Committees
Ministry of Health
1 the Terrace
PO Box 5013
Wellington
6011
Ethics committee country [1] 289406 0
New Zealand
Date submitted for ethics approval [1] 289406 0
16/11/2012
Approval date [1] 289406 0
29/11/2012
Ethics approval number [1] 289406 0
12/NTA/88

Summary
Brief summary
A. Study Objectives:
To compare two groups of anaesthetic registrars in their ability to manage a CICV(cant intubate, cant ventilate) scenario.
Both groups will have the standard teaching method for CICV- then proceed to :-
Group A: No further teaching for CICV (control)
Group B : New Teaching method for CICV.
We will then reassess the registrars at time 0,3,6, and 12 months with blinded assessors for the primary endpoint (time to perform the techniques) and secondary endpoint( task specific check lists and global rating scores)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40642 0
Dr louise sherman
Address 40642 0
Dept anaesthesia, Middlemore hospital, 100 Hospital road, Otahuhu, auckland. 1640
Country 40642 0
New Zealand
Phone 40642 0
+ 642760000
Fax 40642 0
Email 40642 0
louise.sherman@middlemore.co.nz
Contact person for public queries
Name 40643 0
Dr louise sherman
Address 40643 0
Dept anaesthesia,
Middlemore hospital,
100 Hospital Road,
otahuhu,
auckland 1640.
Country 40643 0
New Zealand
Phone 40643 0
+ 642760000
Fax 40643 0
Email 40643 0
louise.sherman@middlemore.co.nz
Contact person for scientific queries
Name 40644 0
Dr louise sherman
Address 40644 0
Dept anaesthesia,
middlemore hospital,
100 Hospital Road,
otahuhu,
auckland 1640
Country 40644 0
New Zealand
Phone 40644 0
+642760000
Fax 40644 0
Email 40644 0
louise.sherman@middlemore.co.nz

No information has been provided regarding IPD availability
Summary results
No Results