eValuatIon of The ALl New Environment for crITicallY Ill Patients (VITALITY)

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective observational study is to investigate if mechanically ventilated patients who are treated in one of the new intensive care unit (ICU) rooms have less delirium compared to patients who are treated in the conventional rooms on the same ICU. The investigators will further evaluate the impact on sleep quality, circadian rhythm, global cognitive function and general outcome parameters. The investigators recorded light and noise conditions in the ICU rooms before start of the redesigning process (subproject light and noise in the intensive care unit (LiNo-ICU)). The investigators will compare data regarding light and noise in the ICU rooms before and after the redesigning process (non-patient related data; ethical vote amendment 08.05.2014).

Detailed Description
-----------------
Delirium is one of the most frequently seen brain organ dysfunctions in the intensive care unit (ICU). Depending on the ICU population, up to 87% have delirium at some point during their critical illness. Patients with delirium have a 3fold increased risk of dying compared to patients without delirium. Studies could show that sedation is the most common independent risk factor for transitioning to delirium. However, the no-sedation approach is often challenging. ICU patients who are not sedated often develop severe anxiety and agitation. These symptoms are often treated with sedatives that have delirogenic side effects. One of the major reasons for anxiety and agitation of patients is the ICU environment which causes distress. The feelings of being surveyed all the time by monitors, being exposed to different kinds of machinery or equipment which sometimes do not work properly are major stressors. The objective of the interdisciplinary research project Parametrische (T)Raumgestaltung was the development of two redesigned intensive care rooms that help to reduce patients' anxiety, helplessness and stress through a holistic architectural approach. The patient's perception and needs, his or her obvious feelings of helplessness and fear are the starting point for a concept that is able to reduce stress factors such as functional and purely technical environment, insufficient lighting conditions and noise. Minimizing or eliminating these common stress factors in the ICU could reduce the need for sedatives and thereby reducing the incidence of ICU delirium.

Official Title
-----------------
eValuatIon of The ALl New Environment for crITicallY Ill Patients (VITALITY)

Conditions
-----------------
Intensive Care Unit Environment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients with age ≥ 18 years Expected intensive Care unit stay ≥ 48 hours Invasive mechanical ventilation or non-invasive mechanical ventilation (with positive ventilation pressure >6 hours/day and high flow >30 liters) on the day of intensive care unit admission Exclusion Criteria: Participation in other clinical studies 10 days before study inclusion and during the study period Patients with psychiatric diseases Patients with a history of stroke and known residual cognitive deficits Patients with a history of cardiopulmonary arrest or pulseless electric activity with cardiopulmonary resuscitation followed by therapeutic hypothermia during entire hospital stay Analphabetism Anacusis or Hypoacusis with hearing aid device, Amaurosis Non-German speaking Allergies to any substance of the electrode fixing material Lacking willingness to save and hand out data within the study Accommodation in an institution due to an official or judicial order History of sleep disorders History or suspicion of hypoxic brain damage (e.g. intracranial bleeding) History or suspicion of elevated intracranial pressure in the last 7 days before study inclusion Patients with an open chest after cardiac surgery The informed consent of the patient or the subject's legally acceptable representative can´t be obtained in time Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critically ill patients in the newly designed ICU rooms<br>Critically ill patients treated in one of the newly designed ICU rooms. | |
| Critically ill patients in the conventional ICU rooms<br>Critically ill patients treated in one of the conventional rooms on the same ICU. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of intensive care unit delirium | Delirium will be measured with the Confusion Assessment Method for the intensive care unit (CAM-ICU) | Participants will be followed up to 10 days after intensive care unit admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circadian plasma melatonin level | Plasma melatonin levels will be assessed in a maximum of three 24-hour periods. Blood samples will be collected every 4 hours within each series of measurements. | Participants will be followed up to 10 days after intensive care unit admission | 
| Circadian plasma cortisone level | Plasma cortison levels will be assessed in a maximum of three 24-hour periods. Blood samples will be collected every 4 hours within each series of measurements. | Participants will be followed up to 10 days after intensive care unit admission | 
| Gene expression of clock genes in blood monocytes | Clock gene levels in blood monocytes will be assessed in a maximum of three 24-hour periods. Blood samples will be collected every 4 hours within each series of measurements. | Participants will be followed up to 10 days after intensive care unit admission | 
| Cholinesterase activity in blood | The Activity of Cholinesterase will be measured at least once a day, maximum three times a day. | Participants will be followed up to 10 days after intensive care unit admission | 
| Core body temperature | Temperature will be measured continuously during those days | Participants will be followed up to 10 days after intensive care unit admission | 
| Severity of intensive care unit delirium | Severity of delirium will be measured with the Intensive Care Delirium Screening Checklist (ICDSC) | Participants will be followed up to 10 days after intensive care unit admission | 
| Severity of anxiety | Severity of anxiety will be measured with the Faces Anxiety Scale (FAS) | Participants will be followed up to 10 days after intensive care unit admission | 
| Post-Traumatic Stress Disorder (PTSD) | At intensive care unit discharge, at hospital discharge, 3 and 6 months after intensive care unit discharge Post-Traumatic Stress Disorder Incidence will be measured with the PTSS-14 Scale | Up to 3 and 6 months after intensive care unit discharge | 
| Barthel Index | Barthel Index will be measured at hospital discharge, 3 and 6 months after intensive care unit discharge. | Up to 3 and 6 months after intensive care unit discharge | 
| Health Related Quality of Life | At 3 and 6 months after intensive care unit discharge. Health Related Quality of Life will be measured with the Short Form questionnaire (SF-36) | Up to 3 and 6 months after intensive care unit discharge | 
| Global cognition and executive function | At intensive care unit discharge, at hospital discharge, 3 and 6 months after intensive care unit discharge. | Up to 3 and 6 months after intensive care unit discharge | 
| Polysomnography | Polysomnography will be performed for a maximum of three 24-hour periods. Polysomnography will start after the 1st, 3rd and 5th night of intensive care unit admission. | Participants will be followed up to 10 days after intensive care unit admission | 
| Subjective sleep quality | Subjective sleep quality will be assessed with the Sleep Questionnaire SF-A from Collegium Internationale Psychiatriae Scalarum at morning of 2nd, 4th and 6th day of study participation. | Participants will be followed up to 10 days after intensive care unit admission | 
| Duration of mechanical and non-mechanical ventilation |  | Participants will be followed for the duration of intensive care stay, an expected average of 1 week | 
| Intensive care unit length of stay |  | Participants will be followed for the duration of intensive care stay, an expected average of 1 week | 
| Hospital length of stay |  | Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks | 
| Level of sedation | Level of sedation will be measured with the Richmond Agitation-Sedation-Scale (RASS) | Participants will be followed up to 10 days after intensive care unit admission | 
| Sedation goal adherence | Adherence of optimal sedation level measured by Richmond Agitation-Sedation-Scale (RASS) | Participants will be followed up to 10 days after intensive care unit admission | 
| Pain level | Pain level will be measured with the Numeric Rating Scale (NRS), or the Visualized Numeric Rating Scale (NRS-V) or the Faces Pain Scale-Revised (FPS-R) or the Behavioral Pain Scale (BPS) or the Behavioral Pain Scale for Non- Intubated (BPS-NI). | Participants will be followed up to 10 days after intensive care unit admission | 
| Amount of administered opioids |  | Participants will be followed up to 10 days after intensive care unit admission | 
| Amount of administered benzodiazepines |  | Participants will be followed up to 10 days after intensive care unit admission | 
| Amount of administered antipsychotics |  | Participants will be followed up to 10 days after intensive care unit admission | 
| Sepsis/Septic shock |  | Participants will be followed up to 10 days after intensive care unit admission | 
| Sequential Organ Failure Assessment (SOFA-Score) |  | Participants will be followed up to 10 days after intensive care unit admission | 
| Simplified Acute Physiology Score (SAPS II) |  | Participants will be followed up to 10 days after intensive care unit admission | 
| Therapeutic Intervention Scoring System (TISS-28) |  | Participants will be followed up to 10 days after intensive care unit admission | 
| Acute Physiological and Chronic Health Evaluation (APACHE II) |  | Participants will be followed up to 10 days after intensive care unit admission | 
| Sleep-wake-behavior monitoring | Sleep-wake-behavior using actigraphy will be assessed continuously. | Participants will be followed up to 10 days after intensive care unit admission | 
| Light levels | Light levels will be measured continuously. | Participants will be followed up to 10 days after intensive care unit admission | 
| Light frequencies | Light frequencies will be measured continuously. | Participants will be followed up to 10 days after intensive care unit admission | 
| Noise levels | Noise levels will be measured continuously. | Participants will be followed for 10 days after intensive care admission | 
| Patients´ perception of the room and light environment |  | Participants will be followed for 10 days after intensive care admission | 
| Hospital mortality |  | Up to 6 months | 
| Multiplex-Genexpression analysis | Ncounter neuroinflammation and micro rna panel are analysed | Participants will be followed up to 10 days after intensive care unit admission |