Prevention of Delirium With Light in the Intensive Care Unit (PreDeLight-ICU)

Charité University Medicine Berlin

Status

Withdrawn

Conditions

Delirium

Treatments

Other: Circadian light

Study type

Interventional

Funder types

Other

Identifiers

NCT01727375

PreDeLight-ICU

Details and patient eligibility

About

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.

Full description

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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