Clinical trial NCT02143661: eValuatIon of The ALl New Environment for crITicallY Ill Patients (VITALITY)
Official title: eValuatIon of The ALl New Environment for crITicallY Ill Patients (VITALITY)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Unit Environment
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2014-05-21
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients

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.

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

Primary outcomes:
measure: Prevalence of intensive care unit delirium
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
Secondary outcomes:
measure: Circadian plasma melatonin level
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Circadian plasma cortisone level
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Gene expression of clock genes in blood monocytes
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Cholinesterase activity in blood
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Core body temperature
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Severity of intensive care unit delirium
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Severity of anxiety
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Post-Traumatic Stress Disorder (PTSD)
timeFrame: Up to 3 and 6 months after intensive care unit discharge
measure: Barthel Index
timeFrame: Up to 3 and 6 months after intensive care unit discharge
measure: Health Related Quality of Life
timeFrame: Up to 3 and 6 months after intensive care unit discharge
measure: Global cognition and executive function
timeFrame: Up to 3 and 6 months after intensive care unit discharge
measure: Polysomnography
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Subjective sleep quality
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Duration of mechanical and non-mechanical ventilation
timeFrame: Participants will be followed for the duration of intensive care stay, an expected average of 1 week
measure: Intensive care unit length of stay
timeFrame: Participants will be followed for the duration of intensive care stay, an expected average of 1 week
measure: Hospital length of stay
timeFrame: Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks
measure: Level of sedation
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Sedation goal adherence
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Pain level
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Amount of administered opioids
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Amount of administered benzodiazepines
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Amount of administered antipsychotics
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Sepsis/Septic shock
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Sequential Organ Failure Assessment (SOFA-Score)
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Simplified Acute Physiology Score (SAPS II)
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Therapeutic Intervention Scoring System (TISS-28)
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Acute Physiological and Chronic Health Evaluation (APACHE II)
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Sleep-wake-behavior monitoring
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Light levels
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Light frequencies
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
measure: Noise levels
timeFrame: Participants will be followed for 10 days after intensive care admission
measure: Patients´ perception of the room and light environment
timeFrame: Participants will be followed for 10 days after intensive care admission
measure: Hospital mortality
timeFrame: Up to 6 months
measure: Multiplex-Genexpression analysis
timeFrame: Participants will be followed up to 10 days after intensive care unit admission
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow - Klinikum, Charité- Universitätsmedizin
Study officials:
affiliation: Charité University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: