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

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).

Study Overview

• Status: Completed
• Conditions: Intensive Care Unit Environment

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
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow - Klinikum, Charité- Universitätsmedizin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Critically ill patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of intensive care unit delirium	Delirium will be measured with the Confusion Assessment Method for the intensive care unit (CAM-ICU)	Participants will be followed up to 10 days after intensive care unit admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Participants will be followed up to 10 days after intensive care unit admission
Core body temperature	Temperature will be measured continuously during those days	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)	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)	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	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.	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)	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.	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.	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.	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
Intensive care unit length of stay		Participants will be followed for the duration of intensive care stay, an expected average of 1 week
Hospital length of stay		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)	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)	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).	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
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
Sepsis/Septic shock		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
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	Sleep-wake-behavior using actigraphy will be assessed continuously.	Participants will be followed up to 10 days after intensive care unit admission
Light levels	Light levels will be measured continuously.	Participants will be followed up to 10 days after intensive care unit admission
Light frequencies	Light frequencies will be measured continuously.	Participants will be followed up to 10 days after intensive care unit admission
Noise levels	Noise levels will be measured continuously.	Participants will be followed for 10 days after intensive care admission
Patients´ perception of the room and light environment		Participants will be followed for 10 days after intensive care admission
Hospital mortality		Up to 6 months
Multiplex-Genexpression analysis	Ncounter neuroinflammation and micro rna panel are analysed	Participants will be followed up to 10 days after intensive care unit admission

Collaborators and Investigators

• Sponsor: Claudia Spies

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): November 11, 2019

Study Registration Dates

• First Submitted: May 19, 2014
• First Submitted That Met QC Criteria: May 20, 2014
• First Posted (Estimate): May 21, 2014

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: Vitality