Prevention of Delirium With Light in the Intensive Care Unit

NCT ID: NCT01727375

Last Updated: 2015-10-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-11-30

Brief Summary

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.

Detailed 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

Conditions

Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard light

In this arm patients receive standard lightening conditions

Group Type: NO_INTERVENTION

No interventions assigned to this group

Ciradian light

In this arm patients receive artificial ceiling light (circadian light) at the bedside.

Group Type: EXPERIMENTAL

Circadian light

Intervention Type: OTHER

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.

Interventions

Circadian light

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Claudia Spies

Univ.-Prof. Dr. Claudia Spies

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Spies, MD, Prof.

Role: STUDY_DIRECTOR

Dept. of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - Universitaetsmedizin Berlin

Locations

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

Berlin, State of Berlin, Germany

Countries

Germany

Other Identifiers

PreDeLight-ICU

Identifier Type: -

Identifier Source: org_study_id