Intensive Care Unit EnvironmentNCT02143661
eValuatIon of The ALl New Environment for crITicallY Ill Patients (VITALITY)
An observational study of Intensive Care Unit Environment, run by Claudia Spies at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Environment
- How many people
- 74 participants
- Where
- 1 siteGermany
- Study dates
- May 2014to 11 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow - Klinikum, Charité- Universitätsmedizin
Berlin, 13353
About this study
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).
Read the 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.
- Conditions
- Intensive Care Unit Environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients in the newly designed ICU rooms | Critically ill patients treated in one of the newly designed ICU rooms. | |
| Critically ill patients in the conventional ICU rooms | Critically ill patients treated in one of the conventional rooms on the same ICU. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of intensive care unit delirium
Delirium will be measured with the Confusion Assessment Method for the intensive care unit (CAM-ICU)
Measured: Participants will be followed up to 10 days after intensive care unit admission
Secondary outcomes (34)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Participants will be followed up to 10 days after intensive care unit admission
Core body temperature
Temperature will be measured continuously during those days
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Participants will be followed up to 10 days after intensive care unit admission
Duration of mechanical and non-mechanical ventilation
Measured: Participants will be followed for the duration of intensive care stay, an expected average of 1 week
Intensive care unit length of stay
Measured: Participants will be followed for the duration of intensive care stay, an expected average of 1 week
Hospital length of stay
Measured: 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)
Measured: 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)
Measured: 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).
Measured: Participants will be followed up to 10 days after intensive care unit admission
Amount of administered opioids
Measured: Participants will be followed up to 10 days after intensive care unit admission
Amount of administered benzodiazepines
Measured: Participants will be followed up to 10 days after intensive care unit admission
Amount of administered antipsychotics
Measured: Participants will be followed up to 10 days after intensive care unit admission
Sepsis/Septic shock
Measured: Participants will be followed up to 10 days after intensive care unit admission
Sequential Organ Failure Assessment (SOFA-Score)
Measured: Participants will be followed up to 10 days after intensive care unit admission
Simplified Acute Physiology Score (SAPS II)
Measured: Participants will be followed up to 10 days after intensive care unit admission
Therapeutic Intervention Scoring System (TISS-28)
Measured: Participants will be followed up to 10 days after intensive care unit admission
Acute Physiological and Chronic Health Evaluation (APACHE II)
Measured: 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.
Measured: Participants will be followed up to 10 days after intensive care unit admission
Light levels
Light levels will be measured continuously.
Measured: Participants will be followed up to 10 days after intensive care unit admission
Light frequencies
Light frequencies will be measured continuously.
Measured: Participants will be followed up to 10 days after intensive care unit admission
Noise levels
Noise levels will be measured continuously.
Measured: Participants will be followed for 10 days after intensive care admission
Patients´ perception of the room and light environment
Measured: Participants will be followed for 10 days after intensive care admission
Hospital mortality
Measured: Up to 6 months
Multiplex-Genexpression analysis
Ncounter neuroinflammation and micro rna panel are analysed
Measured: Participants will be followed up to 10 days after intensive care unit admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2017
- Study completion11 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit EnvironmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claudia Spies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charité University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143661
- Sponsor's protocol ID
- Vitality
- Status last verified
- Apr 2020
- First submitted
- 19 May 2014
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Schmidt S, Heinrich M, Wernecke KD, Spies C, Hancke L, Mueller A, Luetz A. Modification in ICU design may influence circadian serum cholinesterase activities: a proof-of-concept pilot study. Intensive Care Med Exp. 2024 Dec 23;12(1):120. doi: 10.1186/s40635-024-00709-5.
PubMed 39715945Spies C, Piazena H, Deja M, Wernecke KD, Willemeit T, Luetz A; ICU Design Working Group. Modification in ICU Design May Affect Delirium and Circadian Melatonin: A Proof of Concept Pilot Study. Crit Care Med. 2024 Apr 1;52(4):e182-e192. doi: 10.1097/CCM.0000000000006152. Epub 2023 Dec 19.
PubMed 38112493
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eValuatIon of The ALl New Environment for crITicallY Ill Patients (VITALITY)
- ClinicalTrials.gov ID
- NCT02143661
- Acronym / sponsor ID
- Vitality
- Conditions
- Intensive Care Unit Environment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Claudia SpiesUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 21 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients in the newly designed ICU rooms | – | –Critically ill patients treated in one of the newly designed ICU rooms. |
| Critically ill patients in the conventional ICU rooms | – | –Critically ill patients treated in one of the conventional rooms on the same ICU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
34 secondary outcomes
Circadian plasma melatonin level
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Circadian plasma cortisone level
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Gene expression of clock genes in blood monocytes
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Cholinesterase activity in blood
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Core body temperature
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Severity of intensive care unit delirium
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Severity of anxiety
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Post-Traumatic Stress Disorder (PTSD)
Time frame: Up to 3 and 6 months after intensive care unit discharge
Barthel Index
Time frame: Up to 3 and 6 months after intensive care unit discharge
Health Related Quality of Life
Time frame: Up to 3 and 6 months after intensive care unit discharge
Global cognition and executive function
Time frame: Up to 3 and 6 months after intensive care unit discharge
Polysomnography
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Subjective sleep quality
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
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Sedation goal adherence
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Pain level
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
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Light levels
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Light frequencies
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Noise levels
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
Time frame: Participants will be followed up to 10 days after intensive care unit admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Derived from this study: PubMed 39715945Schmidt S, Heinrich M, Wernecke KD, Spies C, Hancke L, Mueller A, Luetz A. Modification in ICU design may influence circadian serum cholinesterase activities: a proof-of-concept pilot study. Intensive Care Med Exp. 2024 Dec 23;12(1):120. doi: 10.1186/s40635-024-00709-5.
- Derived from this study: PubMed 38112493Spies C, Piazena H, Deja M, Wernecke KD, Willemeit T, Luetz A; ICU Design Working Group. Modification in ICU Design May Affect Delirium and Circadian Melatonin: A Proof of Concept Pilot Study. Crit Care Med. 2024 Apr 1;52(4):e182-e192. doi: 10.1097/CCM.0000000000006152. Epub 2023 Dec 19.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Charité University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Environment, run by Claudia Spies at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of intensive care unit delirium (time frame: Participants will be followed up to 10 days after intensive care unit admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02143661, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020; AzTrials last refreshed its copy on 7 Nov 2026.