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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] 303713 0
Nil
Universal Trial Number (UTN)
Trial acronym
DELTA-ICU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium 321134 0
Trauma 321135 0
Condition category
Condition code
Injuries and Accidents 318940 318940 0 0
Other injuries and accidents
Neurological 319613 319613 0 0
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] 320020 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326868 0
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] 326868 0
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] 392915 0
Severity of delirium, using Confusion Assessment Method (CAM-S) scale
Timepoint [1] 392915 0
Twice daily, whenever delirium assessment occurs, for the duration of ICU stay
Secondary outcome [2] 397452 0
Sleep characteristics, by way of polysomnography
Timepoint [2] 397452 0
Once during the ICU stay, between day 3 and 5, only for 10% of the patients included in the sample.
Secondary outcome [3] 397453 0
Mortality rate
Timepoint [3] 397453 0
at 90 days after admission to CIU
Secondary outcome [4] 397454 0
ICU length of stay, collected via data-linkage to medical records
Timepoint [4] 397454 0
At ICU discharge
Secondary outcome [5] 397455 0
Hospital length of stay, collected via data-linkage to medical records
Timepoint [5] 397455 0
At hospital discharge
Secondary outcome [6] 399380 0
Deep venous thrombosis, collected via data-linkage to medical records
Timepoint [6] 399380 0
At ICU discharge
Secondary outcome [7] 399381 0
Rate of pulmonary or other infection, collected via data-linkage of medical records
Timepoint [7] 399381 0
At ICU discharge
Secondary outcome [8] 399382 0
Bleeding from injury site, collected via data-linkage of medical records
Timepoint [8] 399382 0
At ICU discharge
Secondary outcome [9] 399383 0
Pressure ulcers, collected via data-linkage of medical records
Timepoint [9] 399383 0
At ICU discharge
Secondary outcome [10] 399384 0
Need for organ support, including vasopressors, invasive mechanical ventilation, or renal replacement therapy. Collected via data-linkage of medical records
Timepoint [10] 399384 0
At ICU discharge
Secondary outcome [11] 399385 0
Need for blood transfusion, collected via data-linkage of medical records
Timepoint [11] 399385 0
At ICU discharge
Secondary outcome [12] 399386 0
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] 399386 0
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?
No
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] 18936 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 33442 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 308125 0
Hospital
Name [1] 308125 0
John Hunter Hospital
Country [1] 308125 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
Lookout Rd., New Lambton Heights, NSW, 2305
Country
Australia
Secondary sponsor category [1] 308882 0
None
Name [1] 308882 0
Address [1] 308882 0
Country [1] 308882 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308111 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 308111 0
John Hunter Hospital, Lookout Rd., New Lambton Heights, NSW, 2305
Ethics committee country [1] 308111 0
Australia
Date submitted for ethics approval [1] 308111 0
22/03/2021
Approval date [1] 308111 0
16/06/2021
Ethics approval number [1] 308111 0
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 109578 0
Dr F. Eduardo Martinez
Address 109578 0
ICU, John Hunter Hospital, Lookout Rd., New Lambton Heights, NSW, 2305
Country 109578 0
Australia
Phone 109578 0
+61 415391475
Fax 109578 0
Email 109578 0
ed.martinez@health.nsw.gov.au
Contact person for public queries
Name 109579 0
Dr F. Eduardo Martinez
Address 109579 0
ICU, John Hunter Hospital, Lookout Rd., New Lambton Heights, NSW, 2305
Country 109579 0
Australia
Phone 109579 0
+61 249213000
Fax 109579 0
Email 109579 0
ed.martinez@health.nsw.gov.au
Contact person for scientific queries
Name 109580 0
Dr F. Eduardo Martinez
Address 109580 0
ICU, John Hunter Hospital, Lookout Rd., New Lambton Heights, NSW, 2305
Country 109580 0
Australia
Phone 109580 0
+61 249213000
Fax 109580 0
Email 109580 0
ed.martinez@health.nsw.gov.au

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: ed.martinez@health.nsw.gov.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11027Study protocol    381630-(Uploaded-16-03-2021-15-12-54)-Study-related document.docx



Results publications and other study-related documents

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