Prevention of Delirium With Light in the Intensive Care Unit

Charite University, Berlin, Germany

Overview

The purpose of this multicenter randomised controlled trial is to investigate if circadian light at the patients bedside (using Philips HealWell system, CE marked)significantly reduces prevalence of delirium in mechanically ventilated intensive care unit patients.

Patients, who are randomly assigned to the "Lightening arm" will have the circadian light for the whole ICU stay. Light levels at the patients bedside will be measured continuously: embedded light sensors provide irradiance and luminous lux recordings in red, green, and blue color bands and a white light measurement in lux

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Delirium

Interventions

Circadian lightOTHER

Artificial ceiling lighting throughout the day will be provided by the Philips HealWell system, CE marked, which is able to deliver varying light levels and warmer or cooler light according to the time of the day (circadian light). Emergency or examination lighting can be set on demand as circumstances require. Lighting conditions at the patients bedside will be characterized by transformations on the time-series of light levels as measured by a luxmeter. The following metrics will be used for lighting characterization in a period of 24h: mean levels of bright and dark periods, contrast between bright and dark periods, clustering of bright and dark periods, and circadian variation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female patients with age 18 years and above * Intensive Care Unit stay ≥ 48 hours * Invasive mechanical ventilation or not invasive mechanical ventilation (with positive ventilation pressure \>6hours/day and highflow \>30 litres) on the day of Intensive Care Unit admission Exclusion Criteria: * Patients with a history Intensive Care Unit stay during the actual hospital stay * Patients with delirium on the day of Intensive Care Unit admission * Patients with psychiatric diseases * Patients with a history of stroke and known cognitive dysfunctions * Participation in other clinical studies 10 days before study inclusion and during the study period * Psychiatric disease * History of stroke with known residual cognitive deficits * History of Asystolia or pulseless electric activity with cardiopulmonary resuscitation during entire hospital stay * Analphabetism * Unability of German language use * Anacusis or Hypoacusis with hearing aid device, Amaurosis * Allergies to any ingredient 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 * 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

Locations (1)

Center of Sleep Medicine, Campus Charité Mitte, Charité - Universitaetsmedizin

Berlin, State of Berlin, Germany

Outcomes

Primary Outcomes

Prevalence of delirium

Dekirium will be measured with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)