ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621001052820

Ethics application status

Approved

Date submitted

16/03/2021

Date registered

10/08/2021

Date last updated

13/09/2022

Date data sharing statement initially provided

10/08/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

“Delirium in Trauma Patients in ICU: a prospective observational cohort study”
(DELTA-ICU)

Scientific title

“Investigating the Rate of Delirium in Trauma Patients in ICU: a prospective observational cohort study”
(DELTA-ICU)

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

DELTA-ICU

Linked study record

Health condition

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

Delirium

Trauma

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Neurological

Other neurological disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Rate of delirium as a percentage of the total number of delirium assessments in ICU trauma patients defined as a positive CAM-ICU test.
Of those included in the study, 25 patients, or 10% of the total sample, will be selected at random based on the order that they present with every fifth patient given the opportunity to undergo polysomnography. Polysomnography will involved vital signs as well as muscle tone and electroencephalography performed during sleep. This will occur as a single 8 hour study only once during the patients ICU stay. The polysomnography session will occur between day 2 and day 7 of ICU stay. The person who will administer and interpret the polysomnography for this is is a senior sleep scientist from the Department of Respiratory and Sleep medicine at John Hunter Hospital.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Rate of delirium during ICU stay as a propotion of the total number of assessments performed. This will be measured using the Confusion Assessment Method in ICU (CAM-ICU) tool as a dichotomous outcome.

Timepoint [1]

CAM-ICU will be udertaken twice daily by nursing staff in the ICU for the duration of a patient's ICU stay.

Secondary outcome [1]

Severity of delirium, using Confusion Assessment Method (CAM-S) scale

Timepoint [1]

Twice daily, whenever delirium assessment occurs, for the duration of ICU stay

Secondary outcome [2]

Sleep characteristics, by way of polysomnography

Timepoint [2]

Once during the ICU stay, between day 3 and 5, only for 10% of the patients included in the sample.

Secondary outcome [3]

Mortality rate

Timepoint [3]

at 90 days after admission to CIU

Secondary outcome [4]

ICU length of stay, collected via data-linkage to medical records

Timepoint [4]

At ICU discharge

Secondary outcome [5]

Hospital length of stay, collected via data-linkage to medical records

Timepoint [5]

At hospital discharge

Secondary outcome [6]

Deep venous thrombosis, collected via data-linkage to medical records

Timepoint [6]

At ICU discharge

Secondary outcome [7]

Rate of pulmonary or other infection, collected via data-linkage of medical records

Timepoint [7]

At ICU discharge

Secondary outcome [8]

Bleeding from injury site, collected via data-linkage of medical records

Timepoint [8]

At ICU discharge

Secondary outcome [9]

Pressure ulcers, collected via data-linkage of medical records

Timepoint [9]

At ICU discharge

Secondary outcome [10]

Need for organ support, including vasopressors, invasive mechanical ventilation, or renal replacement therapy. Collected via data-linkage of medical records

Timepoint [10]

At ICU discharge

Secondary outcome [11]

Need for blood transfusion, collected via data-linkage of medical records

Timepoint [11]

At ICU discharge

Secondary outcome [12]

Percentage of all sleep stages, including: a. Slow wave sleep, b. Stage 1, c. Stage 2, d. REM. This will be collected by undertaking polysomnography on every fifth patient enrolled to the study after they have given informed consent.

Timepoint [12]

Between day 2 and 4 of ICU stay.

Eligibility

Key inclusion criteria

• 1. Adults (>18 years),
• 2. Trauma patients
• 3. Admitted to the JHH ICU,
• 4. Who can be assessed for delirium twice daily by using the CAM-ICU tool

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• 1. Patients under the age of 18 years of age,
• 2. Comatose (GCS less than 8),
• 3. Patients with confirmed neurological damage from Traumatic Brain Injury (TBI)
• 4. Non-English speaking (would not be able to be assessed with the use of CAM-ICU),
• 5. Pre-existing cognitive impairment, like dementia, etc.

Study design

Purpose

Screening

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

1. Primary outcome will use descriptive statistics
2. Comparison between groups will be done using Student’s t-test for parametric and Mann-Whitney U test for non-parametric data when data is continuous versus categorical. Chi- square or Fisher’s exact test will be used when comparing groups with categorical versus categorical data.
3. Logistic regression to identify the relationship between trauma severity scores and sleep quality with delirium.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

30/09/2022

Actual

Date of last participant enrolment

Anticipated

20/09/2024

Actual

Date of last data collection

Anticipated

3/02/2025

Actual

Sample size

Target

250

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

John Hunter Hospital - New Lambton

Recruitment postcode(s) [1]

2305 - New Lambton

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

John Hunter Hospital

Address [1]

Lookout Road, New Lambton Heights, NSW, 2305

Country [1]

Australia

Primary sponsor type

Hospital

Name

John Hunter Hospital

Address

Lookout Rd., New Lambton Heights, NSW, 2305

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

John Hunter Hospital, Lookout Rd., New Lambton Heights, NSW, 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/03/2021

Approval date [1]

16/06/2021

Ethics approval number [1]

2021/ETH00495

Summary

Brief summary

Delirium is a temporary state of confusion and inattention that occurs in patients who are unwell or have undergone a major injury. Delirium is common and can worsen outcomes. 
This is an observational study of delirium and the factors associated with delirium in trauma patients admitted to the intensive care unit. We hypothesize that the rate of delirium and the severity in this group of patients will be higher than in other populations. There are certain factors that make the occurrence of delirium more likely and this study aims to quantify the occurrence of these factors . Among them is the quality of sleep, as poor quality sleep has been associated with delirium. To do this we will perform nightly assessments of duration of sleep, ask patients who have been discharged from ICU to answer a questionnaire about their sleep in ICU, and a small group of patients will undergo polysomnography, which is a specific sleep test that provides with in depth information about sleep.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr F. Eduardo Martinez

Address

ICU, John Hunter Hospital, Lookout Rd., New Lambton Heights, NSW, 2305

Country

Australia

Phone

+61 415391475

Fax

[email protected]

Contact person for public queries

Name

F. Eduardo Martinez

Address

ICU, John Hunter Hospital, Lookout Rd., New Lambton Heights, NSW, 2305

Country

Australia

Phone

+61 249213000

Fax

[email protected]

Contact person for scientific queries

Name

F. Eduardo Martinez

Address

ICU, John Hunter Hospital, Lookout Rd., New Lambton Heights, NSW, 2305

Country

Australia

Phone

+61 249213000

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

de-identified individual participant data related to published results

When will data be available (start and end dates)?

From the date of publication and five years after that.

Available to whom?

Peer-reviewed journal editors who request it.

Available for what types of analyses?

To verify the validity of the data.

How or where can data be obtained?

Through direct contact with the chief investigator only. Contact via email: [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
11027	Study protocol					381630-(Uploaded-16-03-2021-15-12-54)-Study-related document.docx

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

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Documents added automatically