ANZCTR - Registration

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Impaired driving

Elective surgery

Condition category

Condition code

Public Health

Other public health

Surgery

Other surgery

Intervention/exposure

Study type

Observational

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Postoperative driving performance- Weaving of the car

Timepoint [1]

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]

Postoperative neurocognitve performance- Reaction time (Processing and Psychomotor Speed)

Timepoint [2]

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]

Postoperative driving performance (in-situ)- Ignition activity (on/off)

Timepoint [3]

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]

Postoperative medication consumption

Timepoint [1]

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]

Operative medication consumption during elective surgery procedure

Timepoint [2]

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]

Postoperative driving performance- Standard deviation of speed (SDS, km/h), (Primary outcome)

Timepoint [3]

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]

Postoperative Driving Performance- concentration lapses, (Primary outcome)

Timepoint [4]

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]

Postoperative Neuocognitive Performance- Paired Associates Learning (Primary Outcome)

Timepoint [5]

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]

Postoperative Neuocognitive Performance- Spatial Working Memory (Working Memory & strategy) (Primary Outcome)

Timepoint [6]

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]

Postoperative Neurocognitive Performance- Attention Switching Task (Attention Switching) – Renamed Multitasking Task (MTT) (Primary Outcome)

Timepoint [7]

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]

Postoperative Neurocognitive Performance- One Touch Stocking of Cambridge (Planning) (Primary Outcome)

Timepoint [8]

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]

Postoperative Neurocognitive Performance- Rapid Visual Information Processing (Sustained Attention) (Primary Outcome)

Timepoint [9]

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]

Postoperative Neurocognitive Performance- subjective effects (Primary outcome)

Timepoint [10]

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]

Postoperative driving performance (in situ)- Speed (odometer) (Primary outcome)

Timepoint [11]

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]

Postoperative Driving Performance (in-situ)- harsh braking (Primary outcome)

Timepoint [12]

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]

Postoperative Driving Performance (in-situ)- harsh acceleration (Primary outcome)

Timepoint [13]

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]

Postoperative driving performance (in-situ)- second to second speed (Primary outcome)

Timepoint [14]

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]

Postoperative driving performance (in-situ)- journey tracking (Primary outcome)

Timepoint [15]

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]

Postoperative driving performance (in-situ)- tailgating (Primary outcome)

Timepoint [16]

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]

Postoperative sleep- Sleep Onset Latency (SoL)

Timepoint [17]

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]

Postoperative sleep- Sleep duration (minutes)

Timepoint [18]

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]

Postoperative sleep- Wake after Sleep Onset (WASO)

Timepoint [19]

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]

Postoperative sleep- sleep efficiency (SE)

Timepoint [20]

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

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]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [2]

St Vincent's Private Hospital - Fitzroy

Recruitment hospital [3]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3168 - Clayton

Recruitment postcode(s) [2]

3065 - Fitzroy

Recruitment postcode(s) [3]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Other

Name [1]

2019/20 Royal Automotove Club Victoria (RACV) Sir Edmund Herring Memorial Scholarship

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

Swinburne University of Technology

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Swinburne University of Technology Human Research Ethics (SUHREC)

Ethics committee address [1]

Research Ethics Officer, 
Swinburne Research (H68), 
Swinburne University of Technology, 
P O Box 218, 
Hawthorn, Victoria, 3122.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/05/2019

Approval date [1]

Ethics approval number [1]

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

Public notes

Contacts

Principal investigator

Name

Dr Amie Hayley

Address

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

Australia

Phone

+61 434292666

Email

[email protected]

Contact person for public queries

Name

Amie Hayley

Address

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

Australia

Phone

+61 3 92145585

Email

[email protected]

Contact person for scientific queries

Name

Amie Hayley

Address

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

Australia

Phone

+61 3 92145585

Email

[email protected]

Trial Review

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