Do environmental upgrades in the ICU affect patient's lived experience, sleep, and long-term outcomes? A non-randomised study.

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.