Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000687190p
Ethics application status
Submitted, not yet approved
Date submitted
29/04/2019
Date registered
7/05/2019
Date last updated
22/04/2020
Date data sharing statement initially provided
7/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Establishing fitness to drive protocols following elective day surgery
Scientific title
Establishing fitness to drive protocols following elective day surgery
Secondary ID [1] 298089 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impaired driving 312599 0
Elective surgery 312712 0
Condition category
Condition code
Public Health 311109 311109 0 0
Other public health
Surgery 311110 311110 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Over a two week period, participants will be observed pre-operatively (V1) and post-operatively (V2 and V3) as they undergo scheduled elective day surgery procedures.

Specifically, performance assessments will take place in three stages;

T1: No greater than 1 week pre-surgery admission (in-lab)
T2: up to 24 hours post-hospital discharge (T2a) and at day/s 3 (T2b) and 7 (T2c) postoperatively (at-home)
T3: at 8-days postoperatively (in-lab)

The CANTAB System will be used to assess the cognitive effects at V1 (in-lab), V2a, V2b, V2c (at-home) and V3 (in-lab). Seven tasks will be used in this study to assess cognitive, executive and memory function, specifically:
1. Reaction time (Processing and Psychomotor Speed)
2. Paired Associates Learning
3. Spatial Working Memory (Working Memory & strategy)
4. Attention Switching Task (Attention Switching) – Renamed Multitasking Task (MTT)
5. One Touch Stocking of Cambridge (Planning)
6. Rapid Visual Information Processing (Sustained Attention)
7. Visual Analogue Scale (VAS)

Driving performance will be assessed using the Forum 8 driving simulator at V1 and V3, for a 40 minute duration. The simulator consists of a car unit with adjustable car seats and a dashboard and includes a steering wheel, turn sign indicators, gear lever, brake and accelerator pedals for vehicle control. The system generates realistic roadway scenery which is presented on three integrated TV screens 1.90 meters in front of the centre of the steering wheel. The speed and gear number are displayed on the dashboard and screen. Auditory feedback is provided by speakers and included the sound of the engine, braking, speeding in curves, and driving off-road.

Real-life driving performance will be assessed from V1-V3 using the in-situ IndigoGPS system. The system combines GLONASS GPS technology with in-vehicle diagnostics to provide live tracking and driver activity reporting.
Intervention code [1] 314319 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319885 0
Postoperative driving performance- Weaving of the car
Timepoint [1] 319885 0
After the scheduled day procedure. Specifically, performance at V1 (pre-operative) will be compared to performance at V3 (postoperative). This will be assessed using the Forum 8 driving simulator. Weaving of the car, expressed as standard deviation of the lateral position (SDLP) will be assessed.
Primary outcome [2] 319886 0
Postoperative neurocognitve performance- Reaction time (Processing and Psychomotor Speed)
Timepoint [2] 319886 0
After the scheduled day procedure. Specifically, performance at V1 (pre-operative) will be compared to performance at V2 (V2a, V2b and V2c) and at V3 (postoperative). This will be assessed using the The CANTAB online test. Outcomes include:
1. Reaction time (Processing and Psychomotor Speed)
Primary outcome [3] 319887 0
Postoperative driving performance (in-situ)- Ignition activity (on/off)
Timepoint [3] 319887 0
After the scheduled day procedure. Specifically, performance at V1 (pre-operative) will be compared to performance at V3 (postoperative). This will be assessed using the IndigoGPS system. Ignition activity (on/off), is one of the primary study outcomes (see secondary outcomes for additional outcomes).
Secondary outcome [1] 369785 0
Postoperative medication consumption
Timepoint [1] 369785 0
After the scheduled day procedure. Specifically, medication lists will be completed during the V2 post-operative period (V2a, V2b and V2c). Outcome will be self-disclosed mediation type, dose, duration, polypharmacy
Secondary outcome [2] 369786 0
Operative medication consumption during elective surgery procedure
Timepoint [2] 369786 0
After the scheduled day procedure. Specifically, medication data specific to their elected surgical procedure will be collected via medical records (mediation type, dose, duration, polypharmacy).
Secondary outcome [3] 370023 0
Postoperative driving performance- Standard deviation of speed (SDS, km/h), (Primary outcome)
Timepoint [3] 370023 0
After the scheduled day procedure. Specifically, performance at V1 (pre-operative) will be compared to performance at V3 (postoperative). This will be assessed using the Forum 8 driving simulator. Standard deviation of speed (SDS, km/h) will be assessed
Secondary outcome [4] 370024 0
Postoperative Driving Performance- concentration lapses, (Primary outcome)
Timepoint [4] 370024 0
After the scheduled day procedure. Specifically, performance at V1 (pre-operative) will be compared to performance at V3 (postoperative). This will be assessed using the Forum 8 driving simulator. Lapses will be assessed
Secondary outcome [5] 370025 0
Postoperative Neuocognitive Performance- Paired Associates Learning (Primary Outcome)
Timepoint [5] 370025 0
After the scheduled day procedure. Specifically, performance at V1 (pre-operative) will be compared to performance at V2 (V2a, V2b and V2c) and at V3 (postoperative). This will be assessed using the the CANTAB online test. Outcomes include:
2. Paired Associates Learning
Secondary outcome [6] 370026 0
Postoperative Neuocognitive Performance- Spatial Working Memory (Working Memory & strategy) (Primary Outcome)
Timepoint [6] 370026 0
After the scheduled day procedure. Specifically, performance at V1 (pre-operative) will be compared to performance at V2 (V2a, V2b and V2c) and at V3 (postoperative). This will be assessed using the the CANTAB online test. Outcomes include:
3. Spatial Working Memory (Working Memory & strategy)
Secondary outcome [7] 370027 0
Postoperative Neurocognitive Performance- Attention Switching Task (Attention Switching) – Renamed Multitasking Task (MTT) (Primary Outcome)
Timepoint [7] 370027 0
After the scheduled day procedure. Specifically, performance at V1 (pre-operative) will be compared to performance at V2 (V2a, V2b and V2c) and at V3 (postoperative). This will be assessed using the The CANTAB online test. Outcomes include:

4. Attention Switching Task (Attention Switching) – Renamed Multitasking Task (MTT)
Secondary outcome [8] 370028 0
Postoperative Neurocognitive Performance- One Touch Stocking of Cambridge (Planning) (Primary Outcome)
Timepoint [8] 370028 0
After the scheduled day procedure. Specifically, performance at V1 (pre-operative) will be compared to performance at V2 (V2a, V2b and V2c) and at V3 (postoperative). This will be assessed using the The CANTAB online test. Outcomes include:

5. One Touch Stocking of Cambridge (Planning)

Secondary outcome [9] 370029 0
Postoperative Neurocognitive Performance- Rapid Visual Information Processing (Sustained Attention) (Primary Outcome)
Timepoint [9] 370029 0
After the scheduled day procedure. Specifically, performance at V1 (pre-operative) will be compared to performance at V2 (V2a, V2b and V2c) and at V3 (postoperative). This will be assessed using the The CANTAB online test. Outcomes include:

6. Rapid Visual Information Processing (Sustained Attention)

Secondary outcome [10] 370030 0
Postoperative Neurocognitive Performance- subjective effects (Primary outcome)
Timepoint [10] 370030 0
After the scheduled day procedure. Specifically, performance at V1 (pre-operative) will be compared to performance at V2 (V2a, V2b and V2c) and at V3 (postoperative). This will be assessed using the The CANTAB online test. Outcomes include:

7. Visual Analogue Scale (VAS)
Secondary outcome [11] 370031 0
Postoperative driving performance (in situ)- Speed (odometer) (Primary outcome)
Timepoint [11] 370031 0
After the scheduled day procedure. Specifically, performance at V1 (pre-operative) will be compared to performance at V3 (postoperative). This will be assessed using the IndigoGPS system. Speed (odometer) is one of the primary study outcomes.
Secondary outcome [12] 370032 0
Postoperative Driving Performance (in-situ)- harsh braking (Primary outcome)
Timepoint [12] 370032 0
After the scheduled day procedure. Specifically, performance at V1 (pre-operative) will be compared to performance at V3 (postoperative). This will be assessed using the IndigoGPS system; harsh braking, is one of the primary study outcomes.
Secondary outcome [13] 370033 0
Postoperative Driving Performance (in-situ)- harsh acceleration (Primary outcome)
Timepoint [13] 370033 0
After the scheduled day procedure. Specifically, performance at V1 (pre-operative) will be compared to performance at V3 (postoperative). This will be assessed using the IndigoGPS system; harsh acceleration is one of the primary study outcomes.
Secondary outcome [14] 370034 0
Postoperative driving performance (in-situ)- second to second speed (Primary outcome)
Timepoint [14] 370034 0
After the scheduled day procedure. Specifically, performance at V1 (pre-operative) will be compared to performance at V3 (postoperative). This will be assessed using the IndigoGPS system; second to second speed, is one of the primary study outcomes.
Secondary outcome [15] 370035 0
Postoperative driving performance (in-situ)- journey tracking (Primary outcome)
Timepoint [15] 370035 0
After the scheduled day procedure. Specifically, performance at V1 (pre-operative) will be compared to performance at V3 (postoperative). This will be assessed using the IndigoGPS system; journey tracking is one of the primary study outcomes.
Secondary outcome [16] 370036 0
Postoperative driving performance (in-situ)- tailgating (Primary outcome)
Timepoint [16] 370036 0
After the scheduled day procedure. Specifically, performance at V1 (pre-operative) will be compared to performance at V3 (postoperative). This will be assessed using the IndigoGPS system; tailgating is one of the primary study outcomes.
Secondary outcome [17] 370090 0
Postoperative sleep- Sleep Onset Latency (SoL)
Timepoint [17] 370090 0
After the scheduled day procedure. Specifically, sleep outcomes for the week preceding the scheduled day procedure (1 week pre-operative) will be compared to sleep outcomes for the week following the scheduled procedure (v2-v3). The outcome will be Sleep Onset Latency (minutes). This will be assessed using an Actigraph sleep watch.
Secondary outcome [18] 370091 0
Postoperative sleep- Sleep duration (minutes)
Timepoint [18] 370091 0
After the scheduled day procedure. Specifically, sleep outcomes for the week preceding the scheduled day procedure (1 week pre-operative) will be compared to sleep outcomes for the week following the scheduled procedure (v2-v3). The outcome will be Sleep duration (minutes). This will be assessed using an Actigraph sleep watch.
Secondary outcome [19] 370092 0
Postoperative sleep- Wake after Sleep Onset (WASO)
Timepoint [19] 370092 0
After the scheduled day procedure. Specifically, sleep outcomes for the week preceding the scheduled day procedure (1 week pre-operative) will be compared to sleep outcomes for the week following the scheduled procedure (v2-v3). The outcome will be Wake after sleep onset (Minutes). This will be assessed using an Actigraph sleep watch.
Secondary outcome [20] 370093 0
Postoperative sleep- sleep efficiency (SE)
Timepoint [20] 370093 0
After the scheduled day procedure. Specifically, sleep outcomes for the week preceding the scheduled day procedure (1 week pre-operative) will be compared to sleep outcomes for the week following the scheduled procedure (v2-v3). The outcome will be sleep efficiency (%). This will be assessed using an Actigraph sleep watch.

Eligibility
Key inclusion criteria
Male or female, aged 21 to 55 years;
Undergoing elective day surgery procedures from July 2019 - March 2020
Willing and able to provide written informed consent;
Understands and is willing and able to comply with all study procedures;
Fluent in written and spoken English;
Is a regular driver (> 4,000 km/year) with three years of driving with a full driver’s licence;

Willing to abstain from the following prior to their scheduled in-lab visits (V1 and V3):
No caffeine-containing products within 12 hours prior to testing;
No alcohol within 24 hours prior to testing
No illicit substance use for one week prior to, and for the duration of the trial.
Minimum age
21 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to understand or comply with testing procedures;
Inability to speak or read English;
History of neurological conditions or previous or current history of psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders;
Pregnant, potentially pregnant or lactating;
Unable to participate in scheduled visit, treatment plan, tests and other study procedures according to the protocol;
Current participation in any other studies involving investigational or marketed products within 30 days prior to the screening visit;
Have previously participated in this study.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Demographic data will be presented with summary statistics (number of participants, mean, standard deviation, median and range for variables) for each study. Separate linear mixed effect (LME) models with Maximum Likelihood (ML) estimation will be applied to assess differences in neurocognitive and driving performance variables. Post hoc comparisons will be undertaken where significant condition or interaction effects are observed to determine the significance of differences between groups as a function of treatment group.

Correlations between cognitive outcome scores and the driving simulator across time points will be conducted using Pearson product moment coefficient r. The predictive ability of performance on cognitive outcome to performance on the driving simulator task will be assessed using linear regression models. All statistical analyses will be conducted with the use of SPSS 24.0 (SPSS Inc., USA), and tests are two-tailed with a conventional level of significance of p< 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2020
Actual
Date of last participant enrolment
Anticipated
30/06/2021
Actual
Date of last data collection
Anticipated
31/08/2021
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13668 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 13669 0
St Vincent's Private Hospital - Fitzroy
Recruitment hospital [3] 13670 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 26351 0
3065 - Fitzroy
Recruitment postcode(s) [2] 26352 0
3084 - Heidelberg
Recruitment postcode(s) [3] 26350 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 302618 0
Other
Name [1] 302618 0
2019/20 Royal Automotove Club Victoria (RACV) Sir Edmund Herring Memorial Scholarship
Country [1] 302618 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Swinburne University of Technology
Address
427-451 Burwood Road
Hawthorn, Victoria, 3122
Country
Australia
Secondary sponsor category [1] 302537 0
None
Name [1] 302537 0
Address [1] 302537 0
Country [1] 302537 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303251 0
Swinburne University of Technology Human Research Ethics (SUHREC)
Ethics committee address [1] 303251 0
Research Ethics Officer,
Swinburne Research (H68),
Swinburne University of Technology,
P O Box 218,
Hawthorn, Victoria, 3122.
Ethics committee country [1] 303251 0
Australia
Date submitted for ethics approval [1] 303251 0
03/05/2019
Approval date [1] 303251 0
Ethics approval number [1] 303251 0

Summary
Brief summary
Abstinence from driving a motor vehicle is recommended for 24 hours following procedural sedation. Despite this, as many as 1 in 10 people drive in the first 24 hours after day surgery, and nearly the same amount report driving home immediately after they have been discharged form hospital.

Drivers are often guided by their treating physicians to abstain from driving until ‘physical and mental recovery is compatible with safe driving’, however, there is no clear standard on what
constitutes compatibility with safe driving, nor what benchmark is considered acceptable in terms of physical and mental recovery.



This project aims to gather vital information about the performance-based effects of sedating-type medications on driving performance to provide treatment-relevant data to inform postoperative driving restrictions and inform patient discharge procedures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93014 0
Dr Amie Hayley
Address 93014 0
Swinburne University of Technology,
Faculty of Health, Arts and Design
School of Health Sciences
Centre for Human Psychopharmacology
Mail H24
PO Box 218
Hawthorn, Victoria, 3122
Country 93014 0
Australia
Phone 93014 0
+61 434292666
Fax 93014 0
Email 93014 0
ahayley@swin.edu.au
Contact person for public queries
Name 93015 0
Amie Hayley
Address 93015 0
Swinburne University of Technology,
Faculty of Health, Arts and Design
School of Health Sciences
Centre for Human Psychopharmacology
Mail H24
PO Box 218
Hawthorn, Victoria, 3122
Country 93015 0
Australia
Phone 93015 0
+61 3 92145585
Fax 93015 0
Email 93015 0
ahayley@swin.edu.au
Contact person for scientific queries
Name 93016 0
Amie Hayley
Address 93016 0
Swinburne University of Technology,
Faculty of Health, Arts and Design
School of Health Sciences
Centre for Human Psychopharmacology
Mail H24
PO Box 218
Hawthorn, Victoria, 3122
Country 93016 0
Australia
Phone 93016 0
+61 3 92145585
Fax 93016 0
Email 93016 0
ahayley@swin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This will be discussed with the sponsor prior to disclosure


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
No additional documents have been identified.