ANZCTR - Registration

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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]

nil

Universal Trial Number (UTN)

none

Trial acronym

TEMP-T

Linked study record

Health condition

Health condition(s) or problem(s) studied:

intubation

Emergency intubation

Airway management

Condition category

Condition code

Anaesthesiology

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]

Behaviour

Comparator / control treatment

No cognitive aid (preparation as usual)

Control group

Active

Outcomes

Primary outcome [1]

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]

On completion of airway trolley set-up

Secondary outcome [1]

Time to complete airway trolley set-up

Timepoint [1]

Completion of airway trolley set-up

Secondary outcome [2]

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]

Completion of airway trolley set-up

Secondary outcome [3]

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]

On completion of airway trolley set up.

Secondary outcome [4]

Staff confidence with airway trolley set up.

Timepoint [4]

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]

Staff satisfaction with cognitive aid.

Timepoint [5]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Royal Childrens Hospital - Parkville

Recruitment postcode(s) [1]

3052 - Parkville

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

The Royal Children's Hospital

Address

50 Flemington Road
Parkville, Victoria
3052

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Royal Children's Hospital Human Research and Ethics Committee

Ethics committee address [1]

50 Flemington Road
Parkville, Vic
3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

29/04/2015

Ethics approval number [1]

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]

/AnzctrAttachments/368484-TEMP-T protocol v7.docx

Attachments [2]

/AnzctrAttachments/368484-TEMP-T participant consent form v2.doc.docx

Attachments [3]

/AnzctrAttachments/368484-Intubation Checklist v14.pdf

Attachments [4]

/AnzctrAttachments/368484-Airway Mat ELong v4.pdf

Attachments [5]

/AnzctrAttachments/368484-TEMP-T pre-amble and vignette v4.doc

Attachments [6]

/AnzctrAttachments/368484-TEMP-T Participant Survey v2.doc

Contacts

Principal investigator

Name

Dr Elliot Long

Address

Emergency Department
The Royal Children's Hospital
50 Flemington Road, Parkville, Victoria
3052

Country

Australia

Phone

+61 3 9345 7901

Fax

+61 3 9345 6006

elliot.long@rch.org.au

Contact person for public queries

Name

Elliot Long

Address

Emergency Department
The Royal Children's Hospital
50 Flemington Road, Parkville, Victoria
3052

Country

Australia

Phone

+61 3 9345 7901

Fax

+61 3 9345 6006

elliot.long@rch.org.au

Contact person for scientific queries

Name

Elliot Long

Address

Emergency Department
The Royal Children's Hospital
50 Flemington Road, Parkville, Victoria
3052

Country

Australia

Phone

+ 61 3 9345 7901

Fax

+61 3 9345 6006

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

Source	Title	Year of Publication	DOI
Embase	A randomised controlled trial of cognitive aids for emergency airway equipment preparation in a Paediatric Emergency Department.	2016	https://dx.doi.org/10.1186/s13049-016-0201-z

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically