eValuatIon of The ALl New Environment for crITicallY Ill Patients (VITALITY)
- Conditions
- Intensive Care Unit Environment
- Registration Number
- NCT02143661
- Lead Sponsor
- Claudia Spies
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of intensive care unit delirium Participants will be followed up to 10 days after intensive care unit admission Delirium will be measured with the Confusion Assessment Method for the intensive care unit (CAM-ICU)
- Secondary Outcome Measures
Name Time Method Health Related Quality of Life Up to 3 and 6 months after intensive care unit discharge 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)
Post-Traumatic Stress Disorder (PTSD) Up to 3 and 6 months after intensive care unit discharge 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
Barthel Index Up to 3 and 6 months after intensive care unit discharge Barthel Index will be measured at hospital discharge, 3 and 6 months after intensive care unit discharge.
Circadian plasma cortisone level Participants will be followed up to 10 days after intensive care unit admission 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.
Subjective sleep quality Participants will be followed up to 10 days after intensive care unit admission 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.
Duration of mechanical and non-mechanical ventilation Participants will be followed for the duration of intensive care stay, an expected average of 1 week Level of sedation Participants will be followed up to 10 days after intensive care unit admission Level of sedation will be measured with the Richmond Agitation-Sedation-Scale (RASS)
Gene expression of clock genes in blood monocytes Participants will be followed up to 10 days after intensive care unit admission 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.
Cholinesterase activity in blood Participants will be followed up to 10 days after intensive care unit admission The Activity of Cholinesterase will be measured at least once a day, maximum three times a day.
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 Light frequencies Participants will be followed up to 10 days after intensive care unit admission Light frequencies will be measured continuously.
Noise levels Participants will be followed for 10 days after intensive care admission Noise levels will be measured continuously.
Circadian plasma melatonin level Participants will be followed up to 10 days after intensive care unit admission 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.
Core body temperature Participants will be followed up to 10 days after intensive care unit admission Temperature will be measured continuously during those days
Severity of intensive care unit delirium Participants will be followed up to 10 days after intensive care unit admission Severity of delirium will be measured with the Intensive Care Delirium Screening Checklist (ICDSC)
Severity of anxiety Participants will be followed up to 10 days after intensive care unit admission Severity of anxiety will be measured with the Faces Anxiety Scale (FAS)
Global cognition and executive function Up to 3 and 6 months after intensive care unit discharge At intensive care unit discharge, at hospital discharge, 3 and 6 months after intensive care unit discharge.
Hospital length of stay Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks 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 Hospital mortality Up to 6 months Polysomnography Participants will be followed up to 10 days after intensive care unit admission 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.
Pain level Participants will be followed up to 10 days after intensive care unit admission 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).
Sepsis/Septic shock 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 Participants will be followed up to 10 days after intensive care unit admission Sleep-wake-behavior using actigraphy will be assessed continuously.
Intensive care unit length of stay Participants will be followed for the duration of intensive care stay, an expected average of 1 week Light levels Participants will be followed up to 10 days after intensive care unit admission Light levels will be measured continuously.
Multiplex-Genexpression analysis Participants will be followed up to 10 days after intensive care unit admission Ncounter neuroinflammation and micro rna panel are analysed
Sedation goal adherence Participants will be followed up to 10 days after intensive care unit admission Adherence of optimal sedation level measured by Richmond Agitation-Sedation-Scale (RASS)
Amount of administered opioids Participants will be followed up to 10 days after intensive care unit admission Patients´ perception of the room and light environment Participants will be followed for 10 days after intensive care admission
Trial Locations
- Locations (1)
Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow - Klinikum, Charité- Universitätsmedizin
🇩🇪Berlin, Germany