Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000919112
Ethics application status
Approved
Date submitted
27/05/2019
Date registered
1/07/2019
Date last updated
8/06/2021
Date data sharing statement initially provided
1/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
How does the ICU environment affect patient sleep?
Scientific title
How the ICU environment affects sleep - a baseline study to help develop an improved ICU bedspace to support and improve sleep
Secondary ID [1] 298333 0
None
Universal Trial Number (UTN)
U1111-1234-1431
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep deprivation in ICU 312979 0
Condition category
Condition code
Mental Health 311485 311485 0 0
Other mental health disorders
Public Health 311532 311532 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Study design:
Prospective observational study.

Study plan / participants and recruitment:
Environmental sensors will be placed in three bed-spaces for a minimum 3-week period. These 3 bed spaces have been chosen as they are a sample of the different types of bed-spaces in the TPCH ICU. One is a single patient room, one is an open plan bedspace with natural light and one is an open plan bedspace without natural light. Environmental factors will be measured concurrently for this period.

All consented patients will be assessed for delirium, and a minimum of 5 patients with / without delirium will be included. The results for these two cohorts will be compared to evaluate whether there are any differences in sleep patterns and quality between delirious and non-delirious patients.

Patients will be admitted to ICU and allocated a bedspace as per current routine clinical practice and procedures. The patients that are admitted to the 3 bed-spaces listed above will be approached to participate in the study and provide consent for a 24 hour sleep investigation study concurrent with the environmental measurements.

Consent:
The treating clinical team will notify the researchers of potential candidates. Identified potential participants will then be screened for suitability by an investigator, in consultation with the treating medical officer. Patients will be informed of the purpose and aims of the study and informed consent will be obtained prior to commencing the study. Participants will frequently be incapable of consent in which case consent will be obtained from surrogates making decisions for eligible patients.

Study plan:
Consented patients will have their sleep monitored for 24 hours. They will be monitored overnight between 18.00 & 08.00 via a validated portable sleep monitor. Also, activity will be recorded for a 24-hour period via a validated activity monitor. For the period where the patients are not monitored via a sleep monitor (08.00 - 18.00), the patients' sleep will be monitored by bedside nurse assessments, and recorded in 15-minute blocks. A blood test (5ml) will be taken in the evening before the patient goes to sleep, to determine the melatonin and stress biomarker levels. Patients will also be asked to complete two questionnaires about the quality and quantity of sleep. Perceived sleep quality will be measured in the morning after completing the sleep investigation using the "Richards-Campbell Sleep Questionnaire (RCSQ)" if the patient is deemed to be cognitively able to complete the questionnaire. The patient’s ability to complete the questionnaire will be determined by the researcher after a discussion with the treating medical team. If the patient is unable to complete the survey, the night shift nurse will complete it. Also, patients will be asked to complete the "sleep in the ICU questionnaire" on discharge from ICU.

Equipment:

Sleep will be measured and analysed using the Somtê polysomnography (PSG) recorder. 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. Nine sensors are attached to the patient; 2 under the chin, 1 next to each eye, and 5 on the scalp. These sensors will be attached to the patient’s skin using a water-based glue. The sensors will measure and monitor muscle tone changes using electromyogram (EMG), eye movements using electroocculogram (EOG) and electrical activity in the brain using electroencephalogram (EEG). 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.

Patient activity will be monitored and measured using the ActiwatchTM actigraphy monitor. This is worn on the wrist, and records physical motion and light intensity. It will be worn on the arm with the minimum number of lines and cannulae, to ensure that arm movements are not limited by the patient attachments.

Periods of interrupted or poor-quality sleep and sleep arousals identified will be investigated to determine any alignment with environmental disturbances during the monitoring periods. Data will be obtained from environmental measurements and graphed to determine if there are any correlations between environmental factors and sleep quality or disturbance. These will then be investigated further, with the aim to determine the primary contributors to the sleep disturbance. Also, clinical notes will be reviewed to see if there were any assessments or clinical interventions that could contribute to these sleep disturbance events.
Intervention code [1] 314572 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320187 0
Sleep quality (composite primary outcome) and duration will be objectively measured over a 24 hour period determined by PSG (overnight) and actigraphy (24 hour period).
Timepoint [1] 320187 0
A one off assessment after informed consent obtained.
Primary outcome [2] 320393 0
Perceived quality of sleep determined by validated questionnaires (Richards-Campbell Sleep Questionnaire (RCSQ) & sleep in the ICU questionnaire).
Timepoint [2] 320393 0
RCSQ will be completed the morning after PSG was completed.
Sleep in the ICU questionnaire will be completed on discharge from ICU.
Secondary outcome [1] 370802 0
Environmental factors that disrupt patient's sleep, determined by sensors capturing continuous sound, light, temperature and motion monitoring in the patient's bed-space.
Timepoint [1] 370802 0
A one off assessment after informed consent obtained.

Eligibility
Key inclusion criteria
Inclusion criteria:
• Adult patients (age greater than or equal to 18 years)
• Admitted to the bed-spaces where environmental measurements are being undertaken
• Written informed consent by patient or legally authorized person
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
• Age <18 years
• Unable or unwilling to provide consent to participate
• Deeply and moderately sedated patients (RASS score -3, -4 or -5)
• General anaesthetic, drug overdose or alcohol intoxication in the preceding 24 hours
• Death is deemed imminent
• Brain death
• Cardiovascular instability as determined clinically by the treating therapist or medical staff
• Patients who are deemed to be agitated, aggressive or display unpredictable behaviours
• Patients with open sternums
• Patients with an active infection by a resistant organism

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Observations of interrupted sleep will be plotted against environmental fluctuations and recurrent ICU events such as handovers, interventions, ward rounds, medical emergencies to assess the extent to which each event contributes to observed variations. Patients with delirium will be analysed and compared to patients without delirium. Melatonin and stress biomarker levels will be analysed and correlated to quality of sleep, and sleep disturbances.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/07/2019
Actual
Date of last participant enrolment
Anticipated
30/06/2020
Actual
Date of last data collection
Anticipated
5/07/2020
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13822 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 26580 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 302874 0
Hospital
Name [1] 302874 0
The Prince Charles Hospital / Metro North HHS
Country [1] 302874 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Prince Charles Hospital Critical Care Research Group
Address
Critical Care Research Group
Level 3, Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside, 4032
Country
Australia
Secondary sponsor category [1] 302827 0
Hospital
Name [1] 302827 0
The Prince Charles Hospital
Address [1] 302827 0
The Prince Charles Hospital
Rode Road
Chermside, 4032
Country [1] 302827 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303450 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 303450 0
Ethics committee country [1] 303450 0
Australia
Date submitted for ethics approval [1] 303450 0
14/11/2018
Approval date [1] 303450 0
29/01/2019
Ethics approval number [1] 303450 0
HREC/18/QPCH/82: FUTURE ICU

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

Contacts
Principal investigator
Name 93694 0
Mr Oystein Tronstad
Address 93694 0
Critical Care Research Group
Level 3, Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside, 4032, Qld
Country 93694 0
Australia
Phone 93694 0
+61 7 3139 7232
Fax 93694 0
Email 93694 0
[email protected]
Contact person for public queries
Name 93695 0
Oystein Tronstad
Address 93695 0
Critical Care Research Group
Level 3, Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside, 4032, Qld
Country 93695 0
Australia
Phone 93695 0
+61 7 3139 7232
Fax 93695 0
Email 93695 0
[email protected]
Contact person for scientific queries
Name 93696 0
Oystein Tronstad
Address 93696 0
Critical Care Research Group
Level 3, Clinical Sciences Building
The Prince Charles Hospital
Rode Road
Chermside, 4032, Qld
Country 93696 0
Australia
Phone 93696 0
+61 7 3139 7232
Fax 93696 0
Email 93696 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study's primary purpose is for providing a baseline to allow comparison with new ICU bed-space prototype.


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.