eValuatIon of The ALl New Environment for crITicallY Ill Patients (VITALITY)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Claudia Spies
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Prevalence of intensive care unit delirium
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Prevalence of intensive care unit delirium
Time Frame: 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 Outcomes
- Health Related Quality of Life(Up to 3 and 6 months after intensive care unit discharge)
- Post-Traumatic Stress Disorder (PTSD)(Up to 3 and 6 months after intensive care unit discharge)
- Barthel Index(Up to 3 and 6 months after intensive care unit discharge)
- Level of sedation(Participants will be followed up to 10 days after intensive care unit admission)
- Circadian plasma cortisone level(Participants will be followed up to 10 days after intensive care unit admission)
- Subjective sleep quality(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)
- 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)
- Gene expression of clock genes in blood monocytes(Participants will be followed up to 10 days after intensive care unit admission)
- Cholinesterase activity in blood(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)
- Light frequencies(Participants will be followed up to 10 days after intensive care unit admission)
- Noise levels(Participants will be followed for 10 days after intensive care admission)
- Circadian plasma melatonin level(Participants will be followed up to 10 days after intensive care unit admission)
- Core body temperature(Participants will be followed up to 10 days after intensive care unit admission)
- Severity of intensive care unit delirium(Participants will be followed up to 10 days after intensive care unit admission)
- Severity of anxiety(Participants will be followed up to 10 days after intensive care unit admission)
- Global cognition and executive function(Up to 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)
- Hospital mortality(Up to 6 months)
- Polysomnography(Participants will be followed up to 10 days after intensive care unit admission)
- Pain level(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)
- 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)
- 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)
- Multiplex-Genexpression analysis(Participants will be followed up to 10 days after intensive care unit admission)
- Sedation goal adherence(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)
- Patients´ perception of the room and light environment(Participants will be followed for 10 days after intensive care admission)
Investigators
Claudia Spies
Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow - Klinikum
Charite University, Berlin, Germany