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eValuatIon of The ALl New Environment for crITicallY Ill Patients (VITALITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02143661
Recruitment Status : Completed
First Posted : May 21, 2014
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany

Tracking Information
First Submitted Date May 19, 2014
First Posted Date May 21, 2014
Last Update Posted Date April 30, 2020
Actual Study Start Date May 2014
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 1, 2015)
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)
Original Primary Outcome Measures
 (submitted: May 20, 2014)
Prevalence of intensive care unit delirium [ Time Frame: Participants will be followed up to 6 days after intensive care unit admission ]
Delirium will be measured with the Confusion Assessment Method for the intensive care unit (CAM-ICU)
Change History
Current Secondary Outcome Measures
 (submitted: July 23, 2018)
  • Circadian plasma melatonin level [ Time Frame: 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.
  • Circadian plasma cortisone level [ Time Frame: 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.
  • Gene expression of clock genes in blood monocytes [ Time Frame: 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 [ Time Frame: 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.
  • Core body temperature [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)
  • Post-Traumatic Stress Disorder (PTSD) [ Time Frame: 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 [ Time Frame: 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.
  • Health Related Quality of Life [ Time Frame: 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)
  • Global cognition and executive function [ Time Frame: 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.
  • Polysomnography [ Time Frame: 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.
  • Subjective sleep quality [ Time Frame: 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 [ 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 ]
    Level of sedation will be measured with the Richmond Agitation-Sedation-Scale (RASS)
  • Sedation goal adherence [ Time Frame: 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)
  • Pain level [ Time Frame: 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).
  • 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 ]
    Sleep-wake-behavior using actigraphy will be assessed continuously.
  • Light levels [ Time Frame: Participants will be followed up to 10 days after intensive care unit admission ]
    Light levels will be measured continuously.
  • Light frequencies [ Time Frame: Participants will be followed up to 10 days after intensive care unit admission ]
    Light frequencies will be measured continuously.
  • Noise levels [ Time Frame: Participants will be followed for 10 days after intensive care admission ]
    Noise levels will be measured continuously.
  • 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 ]
    Ncounter neuroinflammation and micro rna panel are analysed
Original Secondary Outcome Measures
 (submitted: May 20, 2014)
  • Circadian plasma melatonin level [ Time Frame: Participants will be followed up to 6 days after intensive care unit admission ]
    Plasma melatonin levels will be assessed in a maximum of three 24-hour periods. The periods will start after the 1st, 3rd and 5th night of intensive care unit treatment. Blood samples will be collected every 4 hours within each series of measurements.
  • Circadian plasma cortisone level [ Time Frame: Participants will be followed up to 6 days after intensive care unit admission ]
    Plasma cortisone levels will be assessed in a maximum of three 24-hour periods. The periods will start after the 1st, 3rd and 5th night of intensive care unit treatment. Blood samples will be collected every 4 hours within each series of measurements.
  • Gene expression of clock genes in blood monocytes [ Time Frame: Participants will be followed up to 6 days after intensive care unit admission ]
    Clock gene levels in blood monocytes will be assessed in a maximum of three 24-hour periods. The periods will start after the 1st, 3rd and 5th night of intensive care unit treatment. Blood samples will be collected every 4 hours within each series of measurements.
  • Cholinesterase activity in blood [ Time Frame: Participants will be followed up to 6 days after intensive care unit admission ]
    The Activity of Cholinesterase will be measured at least once a day, maximum three times a day.
  • Core body temperature [ Time Frame: Participants will be followed up to 6 days after intensive care unit admission ]
    Temperature will be measured continuously during those days
  • Severity of intensive care unit delirium [ Time Frame: Participants will be followed up to 6 days after intensive care unit admission ]
    Severity of delirium will be measured with the Intensive Care Delirium Screening Checklist (ICDSC)
  • Severity of anxiety [ Time Frame: Participants will be followed up to 6 days after intensive care unit admission ]
    Severity of anxiety will be measured with the Faces Anxiety Scale (FAS)
  • Post-Traumatic Stress Disorder (PTSD) [ Time Frame: 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 [ Time Frame: 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.
  • Health Related Quality of Life [ Time Frame: 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)
  • Global cognition and executive function [ Time Frame: 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.
  • Polysomnography [ Time Frame: Participants will be followed up to 6 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.
  • Subjective sleep quality [ Time Frame: Participants will be followed up to 6 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 [ 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 6 days after intensive care unit admission ]
    Level of sedation will be measured with the Richmond Agitation-Sedation-Scale (RASS)
  • Sedation goal adherence [ Time Frame: Participants will be followed up to 6 days after intensive care unit admission ]
    Adherence of optimal sedation level measured by Richmond Agitation-Sedation-Scale (RASS)
  • Pain level [ Time Frame: Participants will be followed up to 6 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).
  • Amount of administered opioids [ Time Frame: Participants will be followed up to 6 days after intensive care unit admission ]
  • Amount of administered benzodiazepines [ Time Frame: Participants will be followed up to 6 days after intensive care unit admission ]
  • Amount of administered antipsychotics [ Time Frame: Participants will be followed up to 6 days after intensive care unit admission ]
  • Sepsis/Septic shock [ Time Frame: Participants will be followed up to 6 days after intensive care unit admission ]
  • Sequential Organ Failure Assessment (SOFA-Score) [ Time Frame: Participants will be followed up to 6 days after intensive care unit admission ]
  • Simplified Acute Physiology Score (SAPS II) [ Time Frame: Participants will be followed up to 6 days after intensive care unit admission ]
  • Therapeutic Intervention Scoring System (TISS-28) [ Time Frame: Participants will be followed up to 6 days after intensive care unit admission ]
  • Acute Physiological and Chronic Health Evaluation (APACHE II) [ Time Frame: Participants will be followed up to 6 days after intensive care unit admission ]
  • Sleep-wake-behavior monitoring [ Time Frame: Participants will be followed up to 6 days after intensive care unit admission ]
    Sleep-wake-behavior using actigraphy will be assessed continuously.
  • Light levels [ Time Frame: Participants will be followed up to 6 days after intensive care unit admission ]
    Light levels will be measured continuously.
  • Light frequencies [ Time Frame: Participants will be followed up to 6 days after intensive care unit admission ]
    Light frequencies will be measured continuously.
  • Noise levels [ Time Frame: Participants will be followed for 6 days after intensive care admission ]
    Noise levels will be measured continuously.
  • Patients´ perception of the room and light environment [ Time Frame: Participants will be followed for 6 days after intensive care admission ]
  • Hospital mortality [ Time Frame: Up to 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title eValuatIon of The ALl New Environment for crITicallY Ill Patients (VITALITY)
Official Title eValuatIon of The ALl New Environment for crITicallY Ill Patients (VITALITY)
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Critically ill patients
Condition Intensive Care Unit Environment
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 20, 2014)
74
Original Estimated Enrollment Same as current
Actual Study Completion Date November 11, 2019
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02143661
Other Study ID Numbers Vitality
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Claudia Spies, Charite University, Berlin, Germany
Study Sponsor Claudia Spies
Collaborators Not Provided
Investigators
Study Director: Claudia Spies, MD, Prof. Charité University, Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date April 2020