ANZCTR - Registration

Reset your password and enable multi-factor authentication (MFA)

For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.

Go to the Login page, click ‘reset password’ and follow the instructions.
Check your email for the link to set a new password.
Create a new password that meets requirements.
Return to the Login page and enter your new password. A verification code will be sent to your email.
Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12625000647437

Ethics application status

Approved

Date submitted

21/11/2024

Date registered

18/06/2025

Date last updated

18/06/2025

Date data sharing statement initially provided

18/06/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

VIsualisation of critical care aGItation and sedation with higher resoLution Assessments and evaluation of a fitNess Tracker: The VIGILANT study

Scientific title

VIsualisation of critical care aGItation and sedation with higher resoLution Assessments and evaluation of a fitNess Tracker in ICU patients: The VIGILANT study

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

The VIGILANT study

Linked study record

Health condition

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

Sedation

Agitation

Intensive Care

Delirium

Mortality

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Anaesthesiology

Pain management

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This study is observational. An updated charting model, registered by the bedside nurses, will be implemented in the ICU as part of standard care and will apply to all patients, regardless of study participation. The study will involve the collection of high-resolution agitation and sedation scores to better capture sedation dynamics, made possible by the increased monitoring frequency provided by this updated charting system. Agitation and sedation scores will continue to be recorded using the Richmond Agitation-Sedation Scale, which has been used in the Christchurch ICU for many years.
Sedation (-5 to 0) will be recorded hourly using the lightest sedation for that hour. Agitation (1 to 4) will be recorded at 15-minute intervals when the patient is agitated. If the patient is not agitated this will be left blank. Data will be collected for the duration of the participants ICU stay using the same chart used for vital signs and drug administration. Data on sedation, agitation, and sedation drugs will be gathered and transferred to an electronic database at discharge. Adherence to this system can be easily assessed by observing patient charts. Roughly 300 participants will be enrolled in the trial. Data collection is expected to take 18 months, finishing in early 2027.

Up to 100 participants will have a smartwatch attached to their wrist to measure heart rate and acceleration data. The smartwatch will remain attached for up to 7 days or until the participant no longer requires sedation. If the participant is extubated during the 7-day period, the watch will be left on to measure the participant’s agitation leading up to and following extubation. If the participant is being extubated outside the 7-day period, and there is at least 12 hours lead-time, the smartwatch may be given to them again to record the extubation and subsequent 12 to 24 hours. In both cases, the watch will be removed 12 to 24 hours following extubation, or if the participant has had a RASS score not exceeding 0 for a minimum of 6 hours post extubation.

Up to 30 participants will have 6 blood samples taken to measure concentrations of propofol, fentanyl and morphine. These participants will be required to meet the following criteria;
• 18 to 80 years of age
• Body mass index 18 to 35 mg/m2
• Expected ICU length of stay of three days or more

For each patient, three samples will be taken on day of admission at 8, 12, and 24 hour time points. Additional samples are taken at 48 and 72 hour time and finally a sample timed with the decision by the treating team to wean sedation.
As soon as a patient is identified as eligible for the main study, they will also be assessed for eligibility for the smartwatch and blood sampling sub studies. If there are no contraindications, consent for all study components will be sought concurrently. Recruitment for the smartwatch and blood sampling sub studies will continue until target enrolment is reached; after that point, only sedation chart data will be collected.
The system will be fully implemented for all ICU patients from the 1st of July, and the study will observe patients admitted after this point for an 18-month period.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Total agitation exposure.

Timepoint [1]

Agitation will be recorded every 15 minutes whenever it is present during periods of intravenous sedation.

Primary outcome [2]

Total sedation exposure.

Timepoint [2]

Sedation will be recorded hourly during periods of intravenous sedation.

Primary outcome [3]

Movement and heart rate data.

Timepoint [3]

The smartwatch will be attached and begin recording data as soon as possible after participant enrolment. It will remain in place for up to 7 days or until intravenous sedation is discontinued, whichever comes first. If sedation weaning and extubation occur outside this 7-day window, the smartwatch will be reattached to capture data during this period. In both cases, the smartwatch will be removed 12 to 24 hours following extubation, or when the participant's RASS score does not exceed 0 for a minimum of 6 hours post-extubation, whichever comes first.

Secondary outcome [1]

Days alive out of the ICU at day 30 after ICU admission.

Timepoint [1]

30 days after ICU admission.

Secondary outcome [2]

Days alive out of the hospital at day 30 after ICU admission

Timepoint [2]

30 days after ICU admission.

Secondary outcome [3]

Days alive and free of delirium at day 30 after ICU admission.

Timepoint [3]

30 days after ICU admission.

Secondary outcome [4]

Blood levels of propofol, fentanyl, and morphine.

Timepoint [4]

Three samples will be taken at 8, 12, and 24 hour time points. Additional samples are taken at 48 and 72 hours and finally a sample timed with the decision by the treating team to wean sedation.

Eligibility

Key inclusion criteria

ICU participants
• requiring intravenous sedation with a targeted level within the range of -2 to 1 (as determined by the Richmond Agitation-Sedation Scale (RASS)).
• who are anticipated to need sedation for at least 48 hours.

For participants eligible for blood sampling the following will also apply;
• 18 to 80 years of age
• Body mass index 18 to 35 mg/m2
• Expected ICU length of stay of three days or more

Minimum age

16 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• Participants who are not expected to survive for 48 hours are excluded from the study
• Participants who are administered neuromuscular blockers
• Participants who cannot move their arms will not have a smartwatch attached but may still be included in the trial of the new Agitation scoring system (for smart watch participation)
• Patients unsuited for additional blood sampling, for example difficulty with blood access or an increased risk for needing blood transfusion (for blood sampling participation)

Study design

Purpose

Duration

Selection

Timing

Prospective

Statistical methods / analysis

The number of participants was chosen to maximise the amount of data which could be collected within a reasonable time frame for the study. Less participants can be monitored by the smartwatches due to the additional criteria for smart watch use. A relatively small number of participants will have blood samples assayed due to the relatively high financial cost of these assays.
Descriptive statistics will be used to present baseline characteristics and data for outcomes. Medians and interquartile range (IQR) will be used for continuous data and numbers and proportions (%) for categorial data.
Regression analysis will be used to analyse categorical and continuous data.
Recorded values from the smart watch and blood samples will be correlated to subjective the clinical observation RASS scale at Christchurch Hospital ICU. The correlation will be assessed using a cross-correlation method to assess similarity of trajectory and bias separately. This data will also be used to design and test a model to estimate and predict RASS scores from physiological data.
To investigate the performance error (PE) of the fentanyl PK-model we will use following formula including the actual plasma concentration (Cm) and the predicted concentration (Cp):
PE (%) = Cm – Cp / Cp x 100. For each patient, the median performance error will be calculated as a measure of bias, and the median absolute performance error as a measure of accuracy.
A two-sided p-level below 0.05 will be considered statistically significant. Statistical analysis will be performed in-house using MATLAB (MathWorks, USA) and the programming software R, version 4.2.2 or later (R Core, 2017. R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria).

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/07/2025

Actual

Date of last participant enrolment

Anticipated

31/12/2026

Actual

Date of last data collection

Anticipated

31/03/2027

Actual

Sample size

Target

300

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Canterbury Doctoral Scholarship

Address [1]

Country [1]

New Zealand

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Erik and Edith Fernströms foundation

Address [2]

Country [2]

Sweden

Funding source category [3]

University

Name [3]

Karolinska Institutet Axel Hirsch travel scholarship

Address [3]

Country [3]

Sweden

Primary sponsor type

University

Name

University of Canterbury

Address

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Health and Disability Ethics Committee

Ethics committee address [1]

https://ethics.health.govt.nz/about/southern-health-and-disability-ethics-committee/

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

22/10/2024

Approval date [1]

10/03/2025

Ethics approval number [1]

2025 FULL 19639

Summary

Brief summary

Hypothesis; "Increasing the frequency with which sedation and agitation is recorded, and continuous monitoring of sedated patients with wearable devices, will provide more useful assessments than standard intermittent scoring, enabling improved correlation of sedation quality with patient outcomes. Measuring blood fentanyl levels will improve our understanding of how these levels change over time and how they correlate with sedation and agitation recordings."
The VIGILANT study is an observational study investigating how ICU sedation and agitation patterns relate to patient outcomes. 
Current tools for assessing sedation are limited by inconsistent frequency which cannot accurately capture sedation dynamics. This study will use the Richmond agitation and sedation scale which has been part of standard of care in Christchurch ICU for many years but it will be registered at an increased and standardized frequency to capture sedation dynamics. This is made possible by the implementing of an updated model of our 24 h chart which allows for more registration points. Additionally, some participants will wear a smart watch to measure their motion and heart rate, and a small subset of participants will have blood samples taken to measure drug levels. The study aims to use this data to improve understanding of sedation dynamics and improve sedation and agitation monitoring, through improved standards and development of objective continuous physiological measurements. Ultimately this study aims to improve sedation management, leading to improved patient outcomes and reduced length of stay.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Geoff Shaw

Address

Dept. of Intensive Care, Christchurch Hospital; 2 Riccarton Avenue, Christchurch Central City, Christchurch 4710

Country

New Zealand

Phone

+64 21 619 686

Fax

[email protected]

Contact person for public queries

Name

Geoff Shaw

Address

Dept. of Intensive Care, Christchurch Hospital; 2 Riccarton Avenue, Christchurch Central City, Christchurch 4710

Country

New Zealand

Phone

+64 21 619 686

Fax

[email protected]

Contact person for scientific queries

Name

Geoff Chase

Address

Dept. of Intensive Care, Christchurch Hospital; 2 Riccarton Avenue, Christchurch Central City, Christchurch 4710

Country

New Zealand

Phone

+64 21 619 686

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor

• HDEC has approved sharing of anonymized participant data.

What individual participant data might be shared?

• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
• Safety data

What types of analyses could be done with individual participant data?

• Any type of analysis (i.e. no restrictions on data re-use)

When can requests for individual participant data be made (start and end dates)?

From:
After publication of main results
To:
No end date

Where can requests to access individual participant data be made, or data be obtained directly?

• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically