An observational study in Intensive Care Unit Environment, sponsored by Claudia Spies. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-30.
Sponsored by Claudia Spies · Observational
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).
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.
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This study's enrollment of 74 is below the median of 130 across 867 observational studies indexed under Critical Illness.
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Critically ill patients
Exclusion Criteria:
Critically ill patients treated in one of the newly designed ICU rooms.
Critically ill patients treated in one of the conventional rooms on the same ICU.
Prevalence of intensive care unit delirium
Delirium will be measured with the Confusion Assessment Method for the intensive care unit (CAM-ICU)
Time frame: Participants will be followed up to 10 days after intensive care unit admission
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Core body temperature
Temperature will be measured continuously during those days
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Duration of mechanical and non-mechanical ventilation
Time frame: Participants will be followed for the duration of intensive care stay, an expected average of 1 week
Intensive care unit length of stay
Time frame: Participants will be followed for the duration of intensive care stay, an expected average of 1 week
Hospital length of stay
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Amount of administered opioids
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Amount of administered benzodiazepines
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Amount of administered antipsychotics
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Sepsis/Septic shock
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Sequential Organ Failure Assessment (SOFA-Score)
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Simplified Acute Physiology Score (SAPS II)
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Therapeutic Intervention Scoring System (TISS-28)
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Acute Physiological and Chronic Health Evaluation (APACHE II)
Time frame: 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.
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Light levels
Light levels will be measured continuously.
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Light frequencies
Light frequencies will be measured continuously.
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Noise levels
Noise levels will be measured continuously.
Time frame: Participants will be followed for 10 days after intensive care admission
Patients´ perception of the room and light environment
Time frame: Participants will be followed for 10 days after intensive care admission
Hospital mortality
Time frame: Up to 6 months
Multiplex-Genexpression analysis
Ncounter neuroinflammation and micro rna panel are analysed
Time frame: Participants will be followed up to 10 days after intensive care unit admission
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Claudia Spies