NCT02143661

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 74 (actual)
• Sponsor: Claudia Spies · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intensive Care Unit Environment

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-04-01
• Completion: 2019-11-11
• First posted: 2014-05-21
• Last updated: 2020-04-30

Locations

1 site across 1 country: Germany