Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000025134
Ethics application status
Approved
Date submitted
13/12/2018
Date registered
10/01/2019
Date last updated
10/01/2019
Date data sharing statement initially provided
10/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient risks associated with blue and green ambient light in modern interventional suites - an anaesthetic perspective.
Scientific title
Patient risks associated with blue and green ambient light in modern interventional suites and incorrect drug identification by anaesthetic staff
Secondary ID [1] 296875 0
Nil known.
Universal Trial Number (UTN)
U1111-1225-5104
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impaired visual performance 310801 0
Condition category
Condition code
Eye 309476 309476 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Volunteer participants that have met the inclusion criterion of passing the Stage 1 visual tests: the Ishihara test for colour blindness, the Farnsworth D-15 hue visual test and the drug labelling test in white light conditions will progress to Stage Two and complete the Farnsworth D-15 hue and drug labelling tests using a random order of items in 1) ambient green light; and in 2) ambient blue light.
The ‘Farnsworth-Test’, 15 cups with different hues will be given to participants to be put in order of hue from the starter cup with a standard colour. Complete passing to mild failure (13-15 correctly) is deemed acceptable. Anything that results in >2 mismatched cups is considered a failure of the test. Accuracy and time to complete the test is recorded.
The Drug-Labelling-Test’, 15 names of commonly-used drugs in anaesthesia (on international standardized colour labels) will be provided on an A4 form (left side), which needs to be matched by participants using identical drug labels on the form’s right side . Accuracy and time to complete the test is recorded. The number of inaccurate selections of drug label will be recorded out of 15.
Ambient Blue light is defined as 1000+/-50 lux of blue light (~470nm) incident on the test objects. Ambient Green light is defined as 1000+/-50 lux of green light (~550nm) incident on the test objects.
The testing procedure commences immediately upon entering the room, and the total time in each light exposure is approximately 5 minutes. The researcher will administer the tests. Participants are allowed up to a maximum of 5 minutes to complete each test. All participants will experience green and blue light conditions with approximately 3 minutes between conditions, to allow for task components to be reset for the subsequent test.
Intervention code [1] 313152 0
Other interventions
Comparator / control treatment
Scores obtained under standard white light (all successes) will be compared with scores obtained under coloured light scores to assess variations in performance.
The human visual system is sensitive to different wavelengths of light; as such it will be necessary to control the illumination of each coloured ambient condition (i.e. white, blue, green). The visual standard sensitivity function for photopic vision will be used to ensure the same perceived brightness for each light source will be used when carrying out experiments.
Ambient white light is defined as 1000+/-50 lux of white light incident on the test objects.
All participants will experience the white light condition. Each participant will experience each of the light conditions, white, green and blue, sequentially, according to a randomised sequence. The 'washout' duration is approximately 3 minutes between lighting conditions.
Control group
Active

Outcomes
Primary outcome [1] 308434 0
Ishihara colour perception test score.
Timepoint [1] 308434 0
Complete test in 5 minutes.
Primary outcome [2] 308435 0
Farnsworth D-15 test score.
Timepoint [2] 308435 0
Complete test in 5 minutes.
Primary outcome [3] 308436 0
Drug Labelling Test score.
Timepoint [3] 308436 0
Complete test in 5 minutes.
Secondary outcome [1] 354952 0
Nil.
Timepoint [1] 354952 0
N/A

Eligibility
Key inclusion criteria
- Volunteers aged >18 years
- Anaesthetists, anaesthetic health practitioners and nurses who participate in any of prescription, preparation, administration, and checking of medications.
- Written informed consent by the volunteer.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- A failure of the Ishihara Test.
- A failure of the Farnsworth D-15 hue test and/or drug labelling test in white light conditions.

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)

Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size and methods for this study have been devised in consultation with a statistician from QIMR Berghofer Medical Research Institute. The primary outcome is success, defined as a score of 13 or more on the Farnsworth D-15 hue test. The acceptable success rate is defined as 0.99 (acceptable failure rate < 0.01), since it would be severely detrimental to patients if anaesthetic staff were unable to distinguish between colours in theatre lighting conditions. Using a binomial test, to have 95% confidence that the success rate was greater than 0.99, we would need to observe 299 successes out of 299 anaesthetic staff recruited. Thus 300 participants involved in Stage 2 will be required to allow for balanced numbers for each randomised sequence. Summary statistics and 95% confidence intervals will be reported.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/01/2019
Actual
Date of last participant enrolment
Anticipated
16/09/2019
Actual
Date of last data collection
Anticipated
16/09/2019
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12720 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 25146 0
4029 - Herston
Recruitment postcode(s) [2] 25147 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 301444 0
Hospital
Name [1] 301444 0
Department of Anaesthesia, Royal Brisbane and Womens Hospital.
Country [1] 301444 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital.
Address
Butterfield Street, Herston, Queensland, 4029. Australia.
Country
Australia
Secondary sponsor category [1] 301133 0
None
Name [1] 301133 0
Address [1] 301133 0
Country [1] 301133 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302179 0
Royal Brisbane & Womens Hospital HREC
Ethics committee address [1] 302179 0
Post Office Royal Brisbane & Women's Hospital Herston Qld 4029
Ethics committee country [1] 302179 0
Australia
Date submitted for ethics approval [1] 302179 0
Approval date [1] 302179 0
10/12/2018
Ethics approval number [1] 302179 0
LNR/2018/QRBW/43509

Summary
Brief summary
As hospitals move towards modern interventional suites, this study aims to identify potential safety risks related to ambient light-related performance deficiencies. Specifically, the aims are to measure the influence of spectral selection in the operating theatre and interventional suite environments and to interpret safety risks for patients in relation to the performance of anaesthetic staff in blue and green ambient light conditions.
Blue and green spectral conditions will negatively affect the ability of anaesthetic staff to correctly detect colour hues using the Farnsworth test and diminish performance in a drug labelling matching task, in staff who performed adequately in white light conditions. This may indicate the potential hazards of incorrect drug identification, impaired patient monitoring performance and delayed clinical response in clinical practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89386 0
Prof Andre van Zundert
Address 89386 0
Royal Brisbane & Women's Hospital,
Butterfield Street, Herston. Qld. 4029.
Country 89386 0
Australia
Phone 89386 0
+617 36465673
Fax 89386 0
Email 89386 0
[email protected]
Contact person for public queries
Name 89387 0
Prof Andre van Zundert
Address 89387 0
Royal Brisbane & Women's Hospital,
Butterfield Street, Herston. Qld. 4029.
Country 89387 0
Australia
Phone 89387 0
+617 36465673
Fax 89387 0
Email 89387 0
[email protected]
Contact person for scientific queries
Name 89388 0
Prof Andre van Zundert
Address 89388 0
Royal Brisbane & Women's Hospital,
Butterfield Street, Herston. Qld. 4029.
Country 89388 0
Australia
Phone 89388 0
+617 36465673
Fax 89388 0
Email 89388 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
777Informed consent form    376582-(Uploaded-13-12-2018-17-36-03)-Study-related document.doc
778Study protocol    376582-(Uploaded-13-12-2018-17-37-18)-Study-related document.docx
779Ethical approval    376582-(Uploaded-13-12-2018-17-38-16)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.