Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000487516
Ethics application status
Approved
Date submitted
2/04/2024
Date registered
19/04/2024
Date last updated
19/04/2024
Date data sharing statement initially provided
19/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Do environmental upgrades in the ICU affect patient's lived experience, sleep, and long-term outcomes? A non-randomised study.
Scientific title
The ICU of the Future - evaluation of the impact of environmental upgrades on patient outcomes in a non-randomised population
Secondary ID [1] 311776 0
None
Universal Trial Number (UTN)
U1111-1292-1554
Trial acronym
Linked study record
Linked to study record ACTRN12623000541606.
The main study, registered as ACTRN12623000541606 was designed as a randomised clincal trial. However, due to patient flow and staff allocation dynamics in the ICU, patients cannot always be enrolled using randomisation or may be missed. As such, we have obtained ethics approval for a sub-study to the original study utilising a case-control study design for patients that are not part of the RCT.

Health condition
Health condition(s) or problem(s) studied:
Sleep deprivation in ICU 333427 0
Mental health in the ICU 333428 0
Condition category
Condition code
Mental Health 330103 330103 0 0
Other mental health disorders
Public Health 330104 330104 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ICU of the Future project is a multi-layered co-design project aimed at achieving the interlinked goals of enabling clinical excellence, improving the patient experience and outcomes, and decreasing the short and long-term burden of admission to the ICU, by using the best available evidence and technology to design an optimal ICU environment. Within the scope of this project, innovative and bespoke design and technological solutions were applied to tailor two allocated bedspaces (beds 19 and 20) to The Prince Charles Hospital ICU patient cohort. Beds 19 and 20 at the TPCH ICU were rebuilt in September – November 2022 to implement the following solutions:
Noise reduction
Multiple solutions were implemented to reduce the noise levels in the upgraded bedspaces. To increase sound absorption, acoustically absorbing wall tiles (that satisfied infection control requirements) were installed, as well as acoustic absorption in the ceiling. To block externally created sounds, the two open-plan bedspaces were converted to single rooms, with a glass door at the front with a double layer of acoustic glass installed to maximise the blocking of sound. Various measures were included to control, reduce, and mask the sounds created within the bedspace. Sound masking was installed, and beds with in-built speakers communicating wirelessly with the patient entertainment system were purchased, allowing the patients to hear the sounds they want to hear (e.g. music) to mask unwanted sounds. Also, the alarm monitors were moved from next to the patient’s head to a monitor closer to the nurse’s computer.
Lights
A bespoke circadian lighting system was installed, closely mimicking natural daylight (the bedspaces are both internal with no windows). This includes an artificial skylight to also assist with circadian rhythms and give the patients a sense of the time of day.
Patient experience
Multiple solutions were implemented to assist with improving the patient experience, improve cognitive stimulation and distraction, and improve the ability to connect with family, friends, and the outside world. Virtual windows and artificial skylights were installed. A patient entertainment system was also installed, and virtual visiting made available to the patient. Bespoke pendants were created to minimise the clutter in the small bedspaces, and design features implemented to make the bedspace feel less clinical.

Patients admitted to environmentally upgraded bedspaces 19 and 20 within the context of regular unit operation, and who were not randomised as part the associated randomised clinical trial (ACTRN12623000541606), will be invited to participate in this study. Outside the RCT, patients are allocated to available beds by the floor coordinator based on clinical acuity and needs and available staffing to maintain a safe and efficient patient care environment. If patients are allocated to these bedspaces outside the RCT, they will remain in the space irrespective of their participation in the research study.

Study plan:
1. Sleep evaluation:
Sleep evaluation will be performed in multiple ways.
1. Single forehead sensor EEG
2. Polysomnography
3. Validated sleep questionnaires

1.1. Single forehead sensor EEG:
Sleep will be measured continuously for the study period (for minimum of 2 days up to maximum 4 days (determined by whether they are still in ICU) following recruitment to the study) using the Somfit single forehead sensor EEG. This is a recently developed wearable device that is light and comfortable for patients to wear while enabling collection of high-quality EEG signals. The technology has previously been tested in other patient cohorts, but not in ICU. We are currently validating this as part of the HREC/2022/QPCH/84211: Validation of a single forehead sensor against polysomnography and evaluation of circadian rhythms in the ICU study (registration number ACTRN12622000854730). When/if we validate that these sensors provide data with sufficient accuracy, we will stop doing the polysomnography part described below.

1.2. Polysomnography:
Polysomnography (PSG) is the gold standard for sleep monitoring. Sleep will be concurrently measured using the portable Somtê polysomnography recorder for a 24-hour period between day 1 and 4 after recruitment to participate. PSG refers to the application of sensors and electrodes for the continuous monitoring of physiological variables during sleep. The Somtê is a small, portable PSG that is worn as a belt across the patient’s thorax. Ten sensors are attached to the patient: 2 under the chin, 1 next to each eye, and 6 on the scalp. The sensors will measure and monitor muscle tone changes using electromyogram (EMG), eye movements using electrooculogram (EOG) and electrical activity in the brain using electroencephalogram (EEG). The EEG sensors will be attached to the patient’s skin using conductive electrode paste. The equipment also has an inbuilt oximeter to measure pulse oximetry and can also measure patient body position as well as background light and sound. The equipment also collects ECG, leg EMG, nasal pressure / thermistor, and ribcage / abdominal movements.

1.3. Validated sleep questionnaire:
Patients will be asked to complete the “sleep in the ICU questionnaire” at the end of their ICU admission. The aim of this questionnaire is to establish the patients’ reported quality and quantity of sleep as well as the reasons for sleep disruptions.

1.4. Other / demographic data collection:
Demographics and other relevant data will be collected and analysed against sleep quality / quantity as well as circadian rhythm disturbances (see below). Data collected include:

• Gender
• Age
• ICU and hospital length of stay
• Mechanical ventilation time
• Mortality
• Severity of illness – SOFA score + APACHE 3
• Medications, specifically benzodiazepines, melatonin, antidepressants, analgesia, inotropes, corticosteroids
• Past medical history, including pre-existing diagnosed sleep disorders
• Primary diagnosis and active problems
• Organ supports, e.g. ventilatory / haemodynamic / renal
• Lines / catheters / drains / feeding tubes (including type + timing of feeding)
• Mobility (amount + highest mobility level) at time of inclusion

2. Circadian rhythms:
Data will be collected from environmental sensors, study records, participants, medical records and routinely collected biological samples. The following parameters will be analysed to evaluate the circadian synchronisation of the patients and study their influence on the outcome of the patients:

2.1. Continuous physiological data (routinely monitored):
Body temperature, heart rate and heart rate variability, blood pressure, enteral feeding rhythm. Also, any relevant medications (e.g. medications that has got the potential to modify patients’ heart rate and blood pressure) will be documented.

2.2. Sleep:
As listed above.

2.3. Blood:
4.5 ml of blood will be collected from participating patients every 4 hours via their arterial line for a 48-hour study period. Participation in the study involves allowing an additional 54ml (less than 4 tablespoons) of blood in total to be collected. Some of the blood will be tested by the TPCH pathology department following normal processes. Some of the blood samples (for RNA analysis) will be de-identified, appropriately labelled and stored at the appropriate temperature in a freezer in the clinical sciences building, before being transferred to the study investigators at the University of Queensland’s Institute for Molecular Bioscience (IMB) for analysis by a team of experts on circadian rhythms. Cortisol, melatonin and IGF1 levels will be analysed, as well as untargeted RNA-sequencing and proteomics analysis, and lastly expression of circadian clock genes in white blood cells, which will allow the evaluation of the impact of the ICU environment on the global circadian rhythmicity of the patients. Measure of WBC circadian clock has been shown to be a valuable readout of the human circadian clock. Also, inflammatory markers (full blood count and c-reactive protein) and haemoglobin will be analysed.

3. Long-term (6 months) outcomes
3.1 Ongoing sleep quality and quantity:
We will perform home sleep testing to evaluate the quality and quantity of sleep at the 6-month timepoint and correlate this with the sleep quality / quantity during ICU admission. Home sleep testing will be performed using the Somfit device to collect physiological data, which is worn on the patient’s forehead using a single-use adhesive-gel electrode. It is paired to a mobile phone which transmits data via Bluetooth. We will also ask the patient to complete the validated Pittsburgh Sleep Quality Index (PSQI) – a 19-item self-report questionnaire that assesses sleep quality over a 1-month time interval. Completion of the index takes approximate 10 minutes.

3.2 Incidence of Post-Intensive Care Syndrome (PICS)
Participants will be asked to complete a suite of carefully selected self-reported measures encompassing three functional domains; (physical, cognitive, and psychological) which will be available both electronically (for those who provide an email address) and as a hard copy (for those who provide a postal address). Completion takes approximately 20-25 minutes. Where participants are unable to complete electronic or hard copy, a member of the research team will contact them on their nominated phone number and complete the questionnaires with the participant over the phone using a standardised script. Means of collection will also be recorded.
Intervention code [1] 328334 0
Treatment: Other
Comparator / control treatment
Bedspaces 17, 18, and 21 of the ICU have been selected as control to the environmentally upgraded bedspaces 19 and 20 due to their general layout (e.g. no window, footprint, etc.). Patients admitted to these bedspaces by the ICU floor coordinator as part of the regular unit bedflow, and who are not randomised as part the associated randomised clinical trial (ACTRN12623000541606), will be invited to participate as control group for this study.

These bedspaces have not been rebuilt and remain structured as part of an open plan ICU design. The bed spaces are generally part of an open floor ICU design, each enclosed by conventional walls on two sides with the option to enclose the space with curtains on the remaining two sides. In comparison to the intervention group, the addressed solutions remained unaltered:
Noise reduction
• No additional features were implemented to increase sound absorption
• No sounds masking features available
• No entertainment system/speakers available, however, patients may use their own devices
• Alarms and monitors remained at their typical locations at the head of the bed
Lights
• Bed spaces do not have access to windows
• No circadian lighting or artificial skylights
• Lighting is provided by conventional hospital ICU lighting, which is reduced over night throughout the ICU at the discretion of attending clinicians and staff
Patient experience
• No entertainment system provided, but patients and/or staff may use personal devices
• Cognitive stimulation and distraction is dependent on individual initiative
• Designed for clinical efficiency

Data may also be analysed against historical data collected as part of other clinical trial associated with the ICU of the future (most prominently ACTRN12622000854730 and ACTRN12622000220763).
Control group
Active

Outcomes
Primary outcome [1] 337865 0
Objective sleep quality (composite primary outcome) and duration
Timepoint [1] 337865 0
continuous measurement over a 2-3 day period within 2 days following recruitment
Primary outcome [2] 337866 0
Perceived quality of sleep
Timepoint [2] 337866 0
Day 3 of the study or at the end of ICU admission, whichever comes first
Primary outcome [3] 337867 0
Maintenance of circadian rhythms between improved and unmodified ICU bedspaces
Timepoint [3] 337867 0
24 hours within 2 days of recruitment (physiological data continuously throughout for 24 hours; sleep via polysomnography continuously throughout for 24 hours; blood collection every 4 hours for a 24 hour period)
Secondary outcome [1] 433503 0
Objective sleep quality (composite primary outcome) and duration
Timepoint [1] 433503 0
2-3 day period continuous measurement (as possible and tolerated by the patient with the option to remove the sensor during the day) 6 months after ICU discharge
Secondary outcome [2] 433504 0
Perceived quality of sleep
Timepoint [2] 433504 0
6 month post ICU discharge
Secondary outcome [3] 433505 0
Prevalence of post-intensive care syndrome (PICS) 6 months post ICU discharge
Timepoint [3] 433505 0
approximately 15 -20 minutes 6 month post ICU discharge
Secondary outcome [4] 433506 0
Impact of PICS on employment and quality of life 6 months post ICU discharge
Timepoint [4] 433506 0
5-10 minutes 6 months post ICU discharge
Secondary outcome [5] 433508 0
Changes to the perceived patterns of circadian alertness 6 months post ICU discharge
Timepoint [5] 433508 0
Day 3 of the study or at the end of ICU admission, whichever comes first, repeat measure 6 month post ICU discharge

Eligibility
Key inclusion criteria
• Adult patients (age greater than or equal to 18 years)
• Admitted to intervention or control beds, but not randomised as part of trial ACTRN12623000541606
• Written informed consent by patient or legally authorised person
• Expected to remain in ICU for >24 hours
• Residing in Australia
• Sufficiently fluent in English to complete recruitment and data collection processes
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Age <18 years
• Unable or unwilling to provide consent to participate
• Patients admitted to ICU immediately following cardiac surgery (including transplantation)
• Deeply and moderately sedated patients (RASS score -3, -4 or -5)
• Recent substantial neurological insult (e.g. stroke)
• Death is deemed imminent
• Patients who are deemed to be agitated, aggressive or display unpredictable behaviours

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Manually analysed PSG data (gold standard) will be validated against manually analysed single forehead sensor data. PSG and equivalent single sensor sleep outcomes will be compared using paired t-tests or the Wilcoxon signed-rank test, depending on the distribution of the sleep outcome. Agreement between PSG and equivalent single sensor sleep outcomes will be evaluated using Bland-Altman plots. Similar analysis will be performed comparing automatically scored against manually scored sleep data. Environmental noise and light, and nursing interventions, will be linked to sleep data where able to analyse reasons for disrupted sleep.

Patients with delirium will be analysed and compared to patients without delirium. Delirium will be assessed twice daily during the study period using CAM-ICU (routinely collected in ICU). Data will be uploaded to IBM SPSS v24 for analysis. Analysis will involve 4 steps:
1. Descriptive statistics will be used to analyse demographic and diagnostic data, using measures of central tendency, range, and frequency
2. The prevalence (present on admission) and incidence (occurring during hospital stay) of delirium
3. Identification of delirium cases (any ‘positive’ assessment) and non-cases and description of each group using demographic data, diagnostic data, and length of stay
4. Comparison of cases and non-cases on demographic and diagnostic data and length of stay will be undertaken using methods appropriate to type of data: T-tests, Chi Square and ANOVA.


For circadian rhythmicity, differential rhythmicity in the different biological parameters will be assessed with a modified version of the DryR analysis tool. Briefly, we will use a multiple mixed linear model with a subsequent model selection based on the Bayesian information criterion to identify differential rhythmic parameters in patients admitted to the ICU. The mixed linear model will include fixed effects from a harmonic regression model and a random effect (patient–specific) on the intercept that deals with the subject–to–subject variation and dependency of the repeated measures. Rhythmic parameters including amplitude and acrophase will be computed from the selected model for each of the conditions. This will identify the parameters that impact on circadian rhythms in the ICU. Also, the incidence of delirium will be collected as described above and analysed against the incidence and severity of circadian rhythm disruptions to explore any correlation between delirium and circadian rhythm abnormalities.

Furthermore, multiple regression analysis tests will be conducted to predict whether variations in lighting cycles (e.g., intensity, spectral power distribution) improve clinical measures for recovery (e.g., hours of sleep at night-time).

Composite outcome to identify the incidence of Post-Intensive Care Syndrome (PICS):
For the purpose of this study a case of PICS will be de?ned as any participant with scores indicating impaired physical (SF36 – Physical Function <32.0), psychological (HADS >7 or TSQ > 5) and/or cognitive function (PROMIS Score <35). Participants who meet criteria for PTSD on TSQ or score highly for Anxiety or Depression on HADS will be notified about their score, and encouraged to attend their GP, or call 1300 MHCALL if they feel in distress. The incidence of PICS will be described using proportions and associated 95% confidence intervals and compared between sub-populations (such as ICU stay <48hrs, planned vs. emergent admission, ventilated vs. non-ventilated) and type of bedspace admitted to. Multivariable regression analysis will be used to identify factors associated with PICS (or not getting PICS). The overall characteristics of the sample will be described using summary statistics. This will help inform the generalisability of our results. The number of patients approached and consented will be tabulated, together with the number who were lost to follow-up, withdrew from the study, or died.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/03/2024
Date of last participant enrolment
Anticipated
14/11/2025
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
30
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26348 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 42321 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 316109 0
Charities/Societies/Foundations
Name [1] 316109 0
The Prince Charles Hospital Foundation
Country [1] 316109 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Critical Care Research Group
Address
Country
Australia
Secondary sponsor category [1] 318287 0
Government body
Name [1] 318287 0
Metro North Hospital and Health Service
Address [1] 318287 0
Country [1] 318287 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314941 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 314941 0
Ethics committee country [1] 314941 0
Australia
Date submitted for ethics approval [1] 314941 0
14/02/2024
Approval date [1] 314941 0
29/02/2024
Ethics approval number [1] 314941 0
HREC/2023/MNHB/94755

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133190 0
Mr Oystein Tronstad
Address 133190 0
Critical Care Research Group, Level 3, Clinical Sciences Building The Prince Charles Hospital Rode Road Chermside, Queensland, 4032
Country 133190 0
Australia
Phone 133190 0
+61 422212452
Fax 133190 0
Email 133190 0
Oystein.Tronstad@health.qld.gov.au
Contact person for public queries
Name 133191 0
Oystein Tronstad
Address 133191 0
Critical Care Research Group, Level 3, Clinical Sciences Building The Prince Charles Hospital Rode Road Chermside, Queensland, 4032
Country 133191 0
Australia
Phone 133191 0
+61 422212452
Fax 133191 0
Email 133191 0
Oystein.Tronstad@health.qld.gov.au
Contact person for scientific queries
Name 133192 0
Oystein Tronstad
Address 133192 0
Critical Care Research Group, Level 3, Clinical Sciences Building The Prince Charles Hospital Rode Road Chermside, Queensland, 4032
Country 133192 0
Australia
Phone 133192 0
+61 422212452
Fax 133192 0
Email 133192 0
Oystein.Tronstad@health.qld.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 data underlying published results will be shared upon reasonable request to the Principal Investigator.
When will data be available (start and end dates)?
Available for 5 years after publication.
Available to whom?
Data will be available to fellow researchers who provide a methodologically-sound proposal who are approved by the Principal Investigator.
Available for what types of analyses?
Data will only be available to achieve the aims of the approved proposal.
How or where can data be obtained?
Data can be obtained through email request to the Principal Investigator, Oystein Tronstad (oystein.tronstad@health.qld.gov.au).


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.