Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000541505
Ethics application status
Approved
Date submitted
5/05/2015
Date registered
27/05/2015
Date last updated
4/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
TEMP-T study: cognitive aids for airway cart set-up in preparation for emergency intubation.
Scientific title
Does the use of a cognitive aid by Emergency Department airway clinicians reduce the omission rate of critical equipment when preparing for intubation compared to no cognitive aid.
Secondary ID [1] 286644 0
nil
Universal Trial Number (UTN)
none
Trial acronym
TEMP-T
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intubation 294969 0
Emergency intubation 294970 0
Airway management 294971 0
Condition category
Condition code
Anaesthesiology 295231 295231 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Control (no cognitive aid). This arm proceeds with airway cart set-up as in their routine clinical practice, Arm 2: Airway Checklist. The airway checklist includes a list of intubation equipment suggested for non-operating room use by the Australian Resuscitation Council. This arm uses the airway checklist as a cognitive aid while setting up the airway cart, Arm 3: Airway Template. The airway template is designed to lie on top of the airway trolley and uses silhouettes of intubation equipment to prompt their inclusion in set-up and also their location on the trolley. This arm uses the airway template as a cognitive aid while setting up the airway cart. The airway cart set-up process will be monitored by a study investigator, but the use or non-use of the cognitive aid will be up to the study participant. The entire process of airway cart set-up takes on average less than 5 minutes, and the study participant can use the cognitive aid for the entirety of this process.
Intervention code [1] 291786 0
Behaviour
Comparator / control treatment
No cognitive aid (preparation as usual)
Control group
Active

Outcomes
Primary outcome [1] 294985 0
Omission rate of critical airway equipment. Omission rate will be calculated using the minimum essential airway equipment required for emergency intubation listed by the Australian Resuscitation Council as a "gold standard".
Timepoint [1] 294985 0
On completion of airway trolley set-up
Secondary outcome [1] 314505 0
Time to complete airway trolley set-up
Timepoint [1] 314505 0
Completion of airway trolley set-up
Secondary outcome [2] 314506 0
Accuracy of airway trolley set-up (were the correct sizes used). Accuracy of sizing will be based on standard age-based equipment for the child in the clinical vignette.
Timepoint [2] 314506 0
Completion of airway trolley set-up
Secondary outcome [3] 314507 0
Variability in location of equipment with use / non-use of cognitive aid for airway trolley set-up. Equipment location will be determined by dividing the airway trolley into 4 rows. The photograph of the airway trolley post set-up will be assessed to determine which row each item is set up in. Each arm of the study (control, checklist, and template) will be assessed for variability of equipment location on the airway trolley.
Timepoint [3] 314507 0
On completion of airway trolley set up.
Secondary outcome [4] 314653 0
Staff confidence with airway trolley set up.
Timepoint [4] 314653 0
Staff will be surveyed post airway trolley set up to rate their confidence that they have not omitted any equipment on a visual analog scale.
Secondary outcome [5] 314654 0
Staff satisfaction with cognitive aid.
Timepoint [5] 314654 0
Staff who have been randomised to use a cognitive aid for airway trolley set up wil be asked to rate their satisfaction with the cognitive aid on a visual analog scale.

Eligibility
Key inclusion criteria
Medical and nursing staff working in the resuscitation area of the Emergency Department of The Royal Children’s Hospital who would be expected to set up the airway trolley as part of their everyday work.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Prior enrollment in the study.

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)
Participants will be approached during clinical shifts in the resuscitation area of the Emergency Department of The Royal Children's Hospital. A sealed envelope containing randomisation groups (control, template, or checklist) for 3 blocks of participants (ED consultant / fellow, ED registrar, ED resuscitation nurse or nurse practitioner) will be opened.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence was generated for 63 patients, 1/3 consultants / fellows, 1/3 registrar's, and 1/3 nurses or nurse practitioners. Randomization will use block randomization using computer generated quasi-random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Our sample size calculation is based upon the absolute omission rate. We estimate from observations of current practice that omission rate is 80% without any template/checklist usage. We estimate that introduction of the template or checklist will result in an improvement to a 20% omission rate. Using a superiority design, recruiting 21 participants per group delivers a power of 0.99 with an alpha of 0.05, therefore 63 participants will be recruited. This is recruitment is feasible with current staffing levels at RCH ED. We estimate that the omission rate will improve from the 80% control rate to 20% using the template or the checklists. Using a superiority design, recruiting 21 participants per group delivers a power of 0.99 with an alpha of 0.05. The statistical analysis will be by intention to treat. The primary outcome is dichotomous and effect sizes will be presented as proportions of intervention and control groups who have reduced their omission rate. Primary and secondary outcomes have non-Gaussian distributions. Odds ratios and 95% confidence intervals will be calculated. Primary outcome analysis will be the comparison of proportions of two independent samples using Chi squared test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/05/2015
Actual
18/05/2015
Date of last participant enrolment
Anticipated
30/06/2015
Actual
30/06/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
63
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3750 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 9629 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 291217 0
Self funded/Unfunded
Name [1] 291217 0
Country [1] 291217 0
Primary sponsor type
Hospital
Name
The Royal Children's Hospital
Address
50 Flemington Road
Parkville, Victoria
3052
Country
Australia
Secondary sponsor category [1] 289896 0
None
Name [1] 289896 0
Address [1] 289896 0
Country [1] 289896 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292780 0
The Royal Children's Hospital Human Research and Ethics Committee
Ethics committee address [1] 292780 0
50 Flemington Road
Parkville, Vic
3052
Ethics committee country [1] 292780 0
Australia
Date submitted for ethics approval [1] 292780 0
Approval date [1] 292780 0
29/04/2015
Ethics approval number [1] 292780 0
35078A

Summary
Brief summary
The study is a prospective randomized controlled study.
The study is designed as a paper-based intervention of senior medical and nursing staff working in the resuscitation room environment in the Emergency Department of The Royal Childrens Hospital.
The study is single centred.
The study is designed to assess the utility of paper-based interventions (checklist or template) in standardizing airway trolley set-up compared to no intervention. As a randomized controlled study, the primary study objective should be free of bias.
Data collected will include the participant role (medical or nursing) and level of seniority. Additionally, study information will include the rate of omitted items from airway trolley set-up, the error rate in airway trolley set-up, the time taken to set up the airway trolley, and staff confidence and satisfaction with airway trolley set-up. A photo of the airway trolley set up will be recorded for blinded assessment of variability in equipment location. No identifiable information will be recorded at any stage of the investigation.
Data will be collected during the participant encounter for omission rate, error rate, and satisfaction / confidence survey. This data will be recorded on a standardized Clinician Report Form (CRF). This will be stored in a locked study cabinet accessible only to the primary investigator. A photograph of the airway trolley set-up will be taken with a dedicated digital camera at the time of participant encounter for later analysis. This will be stored on a password protected external hard drive.
Study preparation and planning will take approximately 2 months. Participant recruitment, based on a total number of participants of 63 with 7 study investigators recruiting 3-5 participants per week, will take approximately 1 month. Data collection and analysis will take approximately 2-3 months.
Trial website
Trial related presentations / publications
Long et al. Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine (2016) 24:8
Public notes
Attachments [1] 434 434 0 0
/AnzctrAttachments/368484-TEMP-T protocol v7.docx
Attachments [2] 435 435 0 0
/AnzctrAttachments/368484-TEMP-T participant consent form v2.doc.docx
Attachments [3] 436 436 0 0
/AnzctrAttachments/368484-Intubation Checklist v14.pdf
Attachments [4] 437 437 0 0
/AnzctrAttachments/368484-Airway Mat ELong v4.pdf
Attachments [5] 438 438 0 0
/AnzctrAttachments/368484-TEMP-T pre-amble and vignette v4.doc
Attachments [6] 439 439 0 0
/AnzctrAttachments/368484-TEMP-T Participant Survey v2.doc

Contacts
Principal investigator
Name 56994 0
Dr Elliot Long
Address 56994 0
Emergency Department
The Royal Children's Hospital
50 Flemington Road, Parkville, Victoria
3052
Country 56994 0
Australia
Phone 56994 0
+61 3 9345 7901
Fax 56994 0
+61 3 9345 6006
Email 56994 0
elliot.long@rch.org.au
Contact person for public queries
Name 56995 0
Dr Elliot Long
Address 56995 0
Emergency Department
The Royal Children's Hospital
50 Flemington Road, Parkville, Victoria
3052
Country 56995 0
Australia
Phone 56995 0
+61 3 9345 7901
Fax 56995 0
+61 3 9345 6006
Email 56995 0
elliot.long@rch.org.au
Contact person for scientific queries
Name 56996 0
Dr Elliot Long
Address 56996 0
Emergency Department
The Royal Children's Hospital
50 Flemington Road, Parkville, Victoria
3052
Country 56996 0
Australia
Phone 56996 0
+ 61 3 9345 7901
Fax 56996 0
+61 3 9345 6006
Email 56996 0
elliot.long@rch.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomised controlled trial of cognitive aids for emergency airway equipment preparation in a Paediatric Emergency Department.2016https://dx.doi.org/10.1186/s13049-016-0201-z
N.B. These documents automatically identified may not have been verified by the study sponsor.